Better Research for Better Health: University of Oxford and Fiocruz partner to improve health research and capacity development globallyby The Editorial Team
Child abuse and neglect is considered one of the medical and social problems with a high prevalence and thus importance. Child welfare policies and practices varies widely across countries. In Sudan, Family and Child Protection Units were established to tackle cases of child abuse, yet a significant number of cases never reach the unit, therefore does not get appropriate care allowing for further consequences of abuse to commence. It is believed that a number of these missed cases actually reach for health care services via emergency departments of hospitals yet they are not being regularly referred. A study was conducted to investigate the reasons behind this gap for further understanding the issue.
Survey launched to understand clinical and research impact of INTERGROWTH-21st tools after 170,000 downloadsby The Editorial Team
Webinar: Pregnant Women & Vaccines Against Emerging Epidemic Threats: Ethics Guidance for Preparedness, Research, and Response, 5 March 2019by The Editorial Team
Several of Global Health Trials' Regional Faculties have implemented exceptional, cost-effective blended learning schemes, using a computer room and the Global Health Network's free eLearning courses to create a novel way of building their research teams' skills and knowledge. The Nigerian faculty explain their experiences here, and you can download their "how to" document on the right hand side of the screen, to use at your own site!
While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility. Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials.
ORRCA (www.orrca.org.uk) is a free, online, searchable database of research around recruitment to Clinical Trials. It aims to help users identify promising recruitment interventions and inform the matching or tailoring of these interventions to specific recruitment challenges faced by different types of trial.
Development of an online resource for recruitment research in clinical trials to organise and map current literatureby Anna Kearney, Nicola Harman, Anna Rosala-Hallas, Claire Beecher, Jane Blazeby, Peter Bower, Mike Clarke, William Cragg, Sinead Dune, Heidi Gardner, Patricia Healy, Lisa Maguire, Nicola Mills, Leila Rooshenas, Ceri Rowlands, Shaun Treweek, Akke Vellinga, Paula Williamson, Carrol Gamble
Transparency in the conduct and reporting of clinical trials is supported by the guidance produced on the content of clinical trial protocols and reporting standards for clinical trials. While the principle features of the statistical analysis are required within this guidance it is generally accepted that a separate Statistical Analysis Plan is also developed as the level of detail appropriate for a SAP is excessive for a protocol. However, there is no detailed guidance on the content of a SAP and consequently, there is marked variation in practice.
The workshop was attended by 120 total participants over two days, and here we provide a report of the workshop, as well as all the presentations from the day.
In the 2013-2016 west Africa outbreak of Ebola Virus Disease (EVD), most of the planned clinical trials failed to reach a conclusion within the time frame of the epidemic. We conduct a comprehensive evaluation of commonly used two- and multi-arm clinical trial designs based on real data, which was recorded during the 2013-16 EVD epidemic in west Africa
Summary of two-day international workshop on new challenges in research ethics in Lima, Peru, August 2018by REDe
Participate in Doctors Without Borders (MSF) survey on the value of sharing medical case reports from humanitarian and resource limited settingsby The Editorial Team
REPORT OF THE 2018 ONE DAY FREE WORKSHOP ON CLINICAL RESEARCH CAPACITY BUILDING FOR CLINICAL RESEARCH IN NIGERIAby Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead, morenike Ukpong, AUGUSTINE ONYEAGHALA - Senior Contributor, ogundokun Olusegun - Senior Contributor, Regional Faculty Committee Member, Ekezie Ralueke Oluchukwu
This report details the workshop held on 7th July 2018 at the Nigerian Airforce Conference Centre, Abuja.
This Guide to Efficient Trial Management, published by the Trial Manager's Network (UK) and available freely online, is a must for all trial managers or coordinators. This link is for the 6th Edition (2018)
Pragmatism in practice: lessons learned during screening and enrollment for a randomised controlled trial in rural northern Ethiopiaby Meseret Molla, Henok Negussie, Moses Ngari, Esther Kivaya, Patricia Njuguna, Fikre Enqueselassie, James A. Berkley, Gail Davey
We use the example of the Gojjam Lymphoedema Best Practice Trial (GoLBeT), a pragmatic trial in a remote rural setting in northern Ethiopia, to extract lessons relevant to other investigators balancing the demands of practicality and community acceptability with internal and external validity in clinical trials.
The Nigerian Global Health Trial Conference 2018 took place on the 30th and 31st of January 2018 the Sickle Cell Centre, Idi-Araba, Lagos. The full report here is shared to allow others to experience and learn from the event.
We have to learn as much as we can about the benefits, risks, costs, and appropriate role of disclosing participant-level data, in service to the ultimate goal of honoring each trial volunteer's altruism.
a milestone for data transparency in clinical research is within reach- it is hoped this is not unnecessarily delayed.
Jimmy Whitworth calls for a more sustainable and palatable pathway be will to build consensus and to create a broad coalition.
Mark Walport and Paul Brest argues that we need to ensure that research outputs are used to maximise knowledge and potential health benefits
In this paper, Andrew Vickers argues that attitudes towards data sharing in the clinical trial community need to rethought, drastically
This study looks at the challneges of data sharing globally.
Publishing the results of all clinical trials, whoever funds them, is required for ethical, scientific, economic, and societal reasons
Rapid release of prepublication data has served the field of genomics well. Attendees at a workshop in Toronto recommend extending the practice to other biological data sets.
Sharing data is not only about the technical dimension such as data management, repositories and libraries; developing countries are concerned about factors that impede data sharing, in particular, fairness
Lack of proportionality. Seven specifications of public interest that override post-approval commercial interests on limited access to clinical databy Strech D, Littmann J
Comparing potential commercial interests with seven specifications of relevant public interest reveals the lack of proportionality inherent in the current practices of EMA and NICE.
John A. Spertus suggests that there needs to be some consideration about the practicalities of data sharing- in how it is shared, investment, and ensuring that data are appropriately analyzed
This article argues that scientists need to feel greater urgency to share their findings quickly, and they need additional avenues to facilitate this process.
Clinical trial transparency and orphan drug development: recent trends in data sharing by the pharmaceutical industryby So D, Joly Y, Knoppers BM
This paper summarises major developments in clinical trial transparency between January and June 2013 and analyses the composition of datasets released by GlaxoSmithKline.
This article looks at the benefits of data sharing, and argues for increasing the accessibility of data
This article details the procedures and requirements for researchers in sharing data from clinical trials.
This article proposes some key characteristics needed in a clinical data warehouses for biomedical research
This article asks the question: how do we achieve fair trade in the sharing of clinical data?
We aimed to make individual patient data from the International Stroke Trial (IST), available for public use, to facilitate the planning of future trials and to permit additional secondary analyses.
This article argues against selective publication and for a clear view of the totality of evidence relevant to many research questions and clinical decisions.
Policies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data analysis may address these subversive practices by improving accountability among industry and investigators.
Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge.
This study looks at the sharing of data between researchers; it details concerns about speed of reply, and highlights an unfortunate situation where researchers are more concerned with losing an advantage than advancing science.
This article investigate clinical trialists’ opinions and experiences of sharing of clinical trial data with investigators who are not directly collaborating with the research team.
Improving health research governance and management in the Western Pacific: A WHO Expert Consultationby Manju Rani, Hendrik Bekedam, Brian S. Buckley
WHO organised an expert consultation on research in the Western Pacific
This article looks at how access to GAIN information has furthered advances in he understanding of the genetic underpinnings of mental-health disorders, diabetes, and psoriasis.
EMA is discussing how to shape the new policy with academics, patient organizations, and drug companies; their final advice is due by the end of next month.
Heather A Piwowar proposes that AHCs can and should lead the transition towards a culture of biomedical data sharing.
The Lancet suggests that transparency in science will increase public trust and reduce the deliberate manipulation of data to score political, financial, or ideological points.
This argues for all the positives of data sharing
In this round table paper, we suggest goals for data sharing and a work plan for reaching them, and challenge respondents to move beyond well intentioned but largely aspirational data sharing plans.
This article argues that it is inappropriate to prescribe exactly when or how researchers should preserve and share data.
This article looks at the ethical problems involved in data sharing within the Genome-Wide Association Studies in Developing Countries
GSK reccently trailed the sharing of deidentified patient-level data. This article describes the approach adopted and answers some of the most common questions received
This article argues that expanded data sharing must be pursued thoughtfully.
This paper discusses important developments in data-sharing policy and highlights factors in health research that may affect policy implementation
This article argues that WHO need to take leadership of the data sharing debate
Is there a duty to share? Ethics of sharing research data in the context of public health emergenciesby Pinky Langat, Dmitri Pisartchik, Diego Silva, Carrie Bernard, Kolby Olsen, Maxwell Smith, Sachin Sahni, Ross Upshur
This article explores the foundation and nature of a duty, if any, that researchers have to share data, specifically in the context of public health emergencies.
A leading US pharmaceutical company, AbbVie, has taken legal action against Europe’s medicines regulator to try to prevent it from releasing data it holds on the safety and efficacy of one of its drugs.
This article describes how to prepare data for sharing with other researchers in a way that minimises risk with respect to the privacy and confidentiality of research participants.
This article aims to address inadequate reporting in randomised controlled trials.
After a global push, cancer clinical trial data is to be shared.
The BMJ Group and the Association of the British Pharmaceutical Industry conference discusses the dangers and promises of trial data
Medical journals should insist on the release of all raw data and a written independent clinical audit.
Peter C. Gøtzsche's speech on the moral obligation and societal benefits of providing free access to all anonymized raw patient data from clinical research
Gøtzsche argues that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests
Peter Gøtzsche argues why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available
The BMj's new policy is a necessary first step towards the full sharing of all anonymised trial data
This paper describes this policy as well as the limited access data sets currently available from NHLBI.
This article suggests the use of trust-enabling techniques to create a solution in which researchers and participants both win with data sharing.
This article presents an overview of genetic privacy breaching strategies, and reviews potential mitigation methods for privacy-preserving dissemination of sensitive data and highlight different cases that are relevant to genetic applications.
The EMA argues that access to full — though appropriately deidentified — data sets from clinical trials will benefit the research-based biopharmaceutical industry.
The impact of the papers we publish depends increasingly on the data they describe. In insisting on data access for referees and readers, we prioritize scientific integrity above all and place the interests of research participants before impact.
As public pressure builds for drug companies to make more results available from clinical trials, the industry should not forget that it relies on collective goodwill to test new therapies.
This article proposes a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles
Transparency interrupted: the curtailment of the European Medicines Agency's Policy on access to documents.by Peter Doshi
Peter Doshi looks at the curtailment of EMA’s policy on access to documents, which is rgues is a major step backward for the transparency of clinical trials and for public health.
The article describes several approaches that can be used in meeting the challenges posed by the sharing of confidential data.
This guide looks at whether deidentification is sufficient in data sharing.
This article looks at rules and regulations for data sharing.
Sharing individual level data from observational studies and clinical trials: a perspective from NHLBIby Sean A Coady, Elizabeth Wagner
The National Heart, Lung, and Blood Institute (NHLBI) has developed a data-sharing protocol focused on balancing the interests of study participants, study investigators, and the research community with independent oversight by the NHLBI IRB.
Editorial: Research data ownership and dissemination: is it too simple to suggest that 'possession is nine-tenths of the lawby Cleary, M, Jackson, D, Walter, G
This article argues that ownership of research data is a complex issue and warrents cafeful examination.
This article provides a description of the barriers to sharing in biobanking, discusses key themes, and concludes that empirical research is required to determine the full extent of the challenges addressed in the literature.
This article looks at the problems caused by inaccessible data to journal reporting, finance and funding; it then looks at possible solutions.
The current study examines genomic research participants' attitudes to explore differences in data sharing preferences between parents of pediatric patients and adult patients.
Elizabeth Pisani and colleagues highlight obstacles to data sharing in public health. However, they omit a potentially crucial one: investigators manipulating evidence that might contradict their hypotheses or conclusions.
Elliot Antman explore issues surrounding data sharing in scientific research
This article looks at the problems of data sharing in clinical trials, data ownership and development of databases to enable safe sharing processes.
The European Commission is looking into ways to support EU member states to address re-emerging preventable diseases and to increase vaccine coverage in Europe. This policy discussion is set against the background of an increase of vaccination hesitancy in several countries, vaccines shortages and vaccines R&D challenges. As part of this process, The European Commission has launched a public consultation.
This study used in-depth interviews and focus group discussions with 48 stakeholders in Vietnam to explore the experiences, attitudes, and expectations that inform ethical and effective approaches to sharing clinical research data.
Views of Ethical Best Practices in Sharing Individual-Level Data From Medical and Public Health Researchby Susan Bull, Nia Roberts, Michael Parker
This scoping review of empirical research and conceptual literature examined stakeholders’ perspectives of ethical best practices in data sharing, particularly in low- and middle-income settings.
Sharing Individual Participant Data from Clinical Trials: An Opinion Survey Regarding the Establishment of a Central Repositoryby Catrin Tudur Smith, Kerry Dwan, Douglas G. Altman, Mike Clarke, Richard Riley, Paula R. Williamson
An article looking at the major issues facing access to, and sharing of, Individual Participant Data.
Amid increasing calls for more effective sharing of individual-level data, commitment to promote access to research data is evident within South Africa’s public research sector, but national guidance and regulation are absent.
A useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’
Seminar presented by the EQUATOR Network's Dr Jen de Beyer from the Centre for Statistics in Medicine, University of Oxford - 11th Sept 2017by GRN coordinator
The Global Health Network showcased its work at the recent ECTMIH 2017 conference in Antwerp. It was a pleasure to meet so many researchers working across varied areas of Global Health. Many thanks to those of you who stopped by the exhibition stand. There was a lot of interest in the network with over 250 signups for more information as well as many great conversations about our online tools and member-sites. Many of you shared some great suggestions for areas to look to develop further such as health economics and NTDs as well as ideas for new eLearning courses.
To highlight the types of activities run by The Global Health Network's innovative regional faculties, and how those can raise the capacity for research, dedicated faculty leaders Glory Oluwagbenga Ogunfowokun (Nigeria) and Jackeline Alger (Honduras) have created these video interviews
Responding to the growing mandate for researchers to share their clinical data, WWARN is joining with partners to host a 3-day workshop in January sponsored by the British Council’s Newton Researcher Links Programme in order to develop the skills and network needed to produce high quality data capable of maximising the impact of initial findings.
Abstract We investigated an outbreak of exanthematous illness in Maceió by using molecular surveillance; 76% of samples tested positive for chikungunya virus. Genetic analysis of 23 newly generated genomes identified the East/Central/South African genotype, suggesting that this lineage has persisted since mid-2014 in Brazil and may spread in the Americas and beyond.
The Nigerian Regional Faculty ran a workshop about Biostatistics on May 20th-21st, 2017. The workshop was well attended with 61 participants, and covered a useful range of topics. You can download the presentations from the day here.
Abstract Background Chikungunya fever is a globally spreading mosquito-borne disease that shows an unexpected neu- rovirulence. Even though the neurological complications have been a major cause of intensive care unit admission and death, to date, there is no systematic analysis of their spectrum available. Objective To review evidence of neurological manifesta- tions in Chikungunya fever and map their epidemiology, clinical spectrum, pathomechanisms, diagnostics, therapies and outcomes. Methods Case report and systematic review of the litera- ture followed established guidelines. All cases found were assessed using a 5-step clinical diagnostic algorithm assigning categories A–C, category A representing the highest level of quality. Only A and B cases were con- sidered for further analysis. After general analysis, cases were clustered according to geospatial criteria for subgroup analysis. Results Thirty-six of 1196 studies were included, yielding 130 cases. Nine were ranked as category A (diagnosis of Neuro-Chikungunya probable), 55 as B (plausible), and 51 as C (disputable). In 15 cases, alternative diagnoses were more likely. Patient age distribution was bimodal with a mean of 49 years and a second peak in infants. Fifty per- cent of the cases occurred in patients <45 years with no reported comorbidity. Frequent diagnoses were encephali- tis, optic neuropathy, neuroretinitis, and Guillain–Barre ́ syndrome. Neurologic conditions showing characteristics of a direct viral pathomechanism showed a peak in infants and a second one in elder patients, and complications and neurologic sequelae were more frequent in these groups. Autoimmune-mediated conditions appeared mainly in patients over 20 years and tended to show longer latencies and better outcomes. Geospatial subgrouping of case reports from either India or Re ́union revealed diverging phenotypic trends (Re ́union: 88% direct viral vs. India: 81% autoimmune). ConclusionsDirect viral forms of Neuro-Chikungunya seem to occur particularly in infants and elderly patients, while autoimmune forms have to be also considered in middle-aged, previously healthy patients, especially after an asymptomatic interval. This knowledge will help to identify future Neuro-Chikungunya cases and to improve outcome especially in autoimmune-mediated conditions. The genetics of Chikungunya virus might play a key role in determining the course of neuropathogenesis. With further research, this could prove diagnostically significant.
The Global Austism Network has launched the Autism Rising intiative, with a mission "to provide a global forum for support of autism... enriching the lives of people with autism, their families and their communities worldwide". They are inviting all those who are involved with ASD* to participate in a survey "to evaluate different approaches to the diagnosis of ASD, treatment options and the resources available in different communities". To learn more and participate, please click HERE. *Autism Spectrum Disorder
Got a burning passion for health? Ready to make a difference? Join Cochrane Crowd, their partners Mark2Cure and the collective global volunteer network for an online MedLit Blitz, May 9th-12th. Together they will create health evidence and transform biomedical discovery.
A prospective, qualitative, multi-site study investigating the barriers and enablers to locally-led clinical trial conduct in Ethiopia, Cameroon, and Sri Lanka; here the protocol, methods and instroduction are available for readers.
This short film shows the impact of the CHAPAS trial on patient health and future possibilities of a small boy from Malawi.
This is a great video of a talk given at the Oxford Martin School by Professor Kevin Marsh.
In this podcast Dr Jacob McKnight talks about his experiences in neonatal nursing delivery and research in Kenya.
There has been steady progress in LMIC health research capacity, but major barriers to research persist and more empirical evidence on development strategies is required.
Become a Cochrane citizen scientist. Anyone can join their collaborative volunteer effort.
This article addresses the global burden of musculoskeletal trauma in particular in low and middle income countries.
This book is a collection of fictionalised case studies of everyday ethical dilemmas and challenges, encountered in the process of conducting global health research in places where the effects of global, political and economic inequality are particularly evident.
It is time to revise the international Good Clinical Practices guidelines: recommendations from non-commercial North–South collaborative trialsby GHN Editors
The Good Clinical Practices (GCP) codes of the WHO and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without consideration for the challenges faced in low and middle income countries (LMICs).
The TDR Global Competency Framework for Clinical Research: a set of tools to help develop clinical researchersby TDR, The Global Health Network
The TDR Global Competency Framework for Clinical Research is a flexible framework which lists all the competencies that should be demonstrated by a research team to carry out a successful clinical study. It can be used for any research study, regardless of the size of the team and of the study itself. It can help to plan the staffing requirements for a study, to help carry out appraisals of staff, to help individuals plan their career development, and to help to develop educational curricula for research staff.
Around half of the clinical trials done on medicines we use today are not published; a tragic truth that needs to be changed.
The impact of occupational stress on nurses’ caring behaviors and their health related quality of lifeby Pavlos Sarafis, Eirini Rousaki, Andreas Tsounis, Maria Malliarou, Liana Lahana, Panagiotis Bamidis, Dimitris Niakas, Evridiki Papastavrou
BMJ Blog - Richard Smith: The “micro-macro problem” and the difficulty of using evidence to make policyby The Editorial Team
In this BMJ blog, Richard Smith discusses the challenges and process of getting research evidence into policy and practise
This video seminar describes research to develop a low-cost, field-based test to detect several slow-clearing ACT drug compounds from unprocessed fingerstick blood samples
Please see this Sky News interview where we were asked by Sky News to comment on the announcement about this bold vision to tackle all diseases.
Launch of Mesh: a new online platform co-created by its users and aiming to improve Community Engagementby The Editorial Team
Today,The Global Health Network launches Mesh: a new online platform co-created by its users and aiming to improve Community Engagement with health in low and middle income countries.
A recently published paper in PLOS Medicine has investigated how adverse event data from clinical trials are summarised and consequently reported in published papers.
Informed consent is vital in clinical research. Achieving adequate comprehension in low literacy settings however is a significant challenge.
How the war in Syria is decimating human resources for health and health systems.
The team interview panel members talking about the Novartis Access Initiative's work on NCDs.
Professor Sallie Lamb talks about the history of clinical trials, and explains important concepts such as randomisation, masking and minimisation of bias.
This review describes the landscape of schistosomiasis clinical research. The volume of data and the methodological and reporting heterogeneity identified all indicate that there is scope for an individual participant-level database, to allow for standardised analyses.
Professor Scheffler provided a conceptual framework that shows how pay for performance works in health, and discusses the results of selected case studies.
The European Mobile Laboratory, EMLab, was the first EBOV diagnostics unit deployed to the outbreak epicentre by WHO in March 2014.
Obstetric fistula is an important global health issue that negatively affects the lives of countless women, and the team highlight what can be done to prevent and treat fistula.
This week, TWiGH looks at the weekly top global health stories grabbing headlines around the world - May 2016.
Watch the Malaria Consortium's excellent video summary of the amazing progress that has been made to address malaria, and also highlighing the key challenges that remain.
Laboratory systems and diagnostic technologies are a critical pillar in the fight against malaria. The World Health Organization (WHO) recommends diagnostic testing for all people with suspected malaria before treatment is administered.
Interview with Dr. Frank Smith of No More Epidemics Campaign and Management Science for Health (MSH) to learn more about their campaign to end epidemics.
What was it like making a documentary during the heat of the Ebola outbreak in Liberia?
Join us in Oxford on the 25th of April to mark World Malaria Day 2016 at a series of talks and a panel discussion. The speakers will present their latest projects and help us to understand the unique and interconnected findings of their research.
Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopiaby Henok Negussie, Thomas Addissie, Adamu Addissie, Gail Davey
This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts.
This framework describes key components of capacity development, indicators for their success and ways to verify capacity development.
U.S. efforts to combat the Zika virus in the US and abroad
Travel Medicine and Infectious Diseases have evolved rapidly in recent decades as outbreaks such as SARS, Avian Influenza, Ebola, MERS, Chikungunya, and Zika virus have demonstrated how quickly infections can cross international borders.
Public Health Degrees.org is a comprehensive search engine designed for students who are interested in learning more about Public Health and Health Sciences programs around the United States.
Global Research Nurses is proud to announce skills sharing workshops at Mumbai and Gujarat, India in March 2016
This glossary provides definitions of some common terms encountered in clinical research.
Greg Martin talks about four areas of competencies needed to be effective in public health and global health. He places particular importance on management, leadership and governance.
Abstract The luncheon for research nurses, supported by the Global Health Trials’ South African faculty and Global Research Nurses, was held at the University of Cape Town on 6 November 2015. The purpose of the event, which attracted 65research nurses, was to provide face to face interaction for research nurses and a platform for sharing challenges and triumphs for both UK and South African research nurses.
The Zika virus is another wild card dealt to us by nature. It was first discovered in 1947.
Video seminar by Chelsea McMullen, Operational Support Officer, International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC), presented at the University of Oxford, 21st October 2015
Quality of care assessment is one of the ways of evaluating what the health system is providing, however, such monitoring depends on an ability to measure quality with the availability of high quality data.
Abstract Chikungunya is an emerging arbovirus that is characterized into four lineages. One of these, the Asian genotype, has spread rapidly in the Americas after its introduction in the Saint Martin island in October 2013. Unexpectedly, a new lineage, the East-Central-South African genotype, was introduced from Angola in the end of May 2014 in Feira de Santana (FSA), the second largest city in Bahia state, Brazil, where over 5,500 cases have now been reported. Number weekly cases of clinically confirmed CHIKV in FSA were analysed alongside with urban district of residence of CHIKV cases reported between June 2014 and October collected from the municipality’s surveillance network. The number of cases per week from June 2014 until September 2015 reveals two distinct transmission waves. The first wave ignited in June and transmission ceased by December 2014. However, a second transmission wave started in January and peaked in May 2015, 8 months after the first wave peak, and this time in phase with Dengue virus and Zika virus transmission, which ceased when minimum temperature dropped to approximately 15°C. We find that shorter travelling times from the district where the outbreak first emerged to other urban districts of FSA were strongly associated with incidence in each district in 2014 (R2).
To highlight the Neglected Tropical Disease (NTD) Awareness Week, TWiGH brings to you a conversation with Amy Maxmen- who recently wrote a series on Mycetoma with Global Health Now.
This Week in Global Health or TWiGH presents Global Health Out Loud with Sulzhan Bali & Jessica Taaffe. This week they discuss Zika virus.
Call for Papers: Special issue on strengthening tuberculosis diagnostic networks in Africa - African Journal of Laboratory Medicine
Malaria remains a major global health threat. In the last fifteen years there has been remarkable progress in reducing cases and deaths due to malaria.
Deployed in April 2015, we have established proof-of-principle for real-time genomic surveillance by generating over 40 genome sequences in as little as 48 hours from obtaining a patient sample and feeding the information back to the Ebola central coordination team.
This talk covers several research projects we are undertaking to assess the Electronic Health Record landscape in Kenya and current large-scale projects to roll out Open Source EHR systems to public hospitals.
Building on the concept of rapid learning health systems, Dr. Peek’s seminar focuses on the use of health information technology to address epidemiological and public health questions and to accelerate the translation of research findings to clinical practice.
A seminar presented by Dr Jalemba Aluvaala in the Centre for Tropical Medicine and Global Health, University of Oxford
Looking for a job in global health? A 4 part series that takes a look at what you need to do to get your career in global health off to a good start.
Damalie Nakanjako (MBChB, MMED, PhD) is an internist whose work focuses on optimizing HIV treatment outcomes and reducing HIV-associated morbidity and mortality in sub-Saharan Africa.
Twitter plays role in information distribution during emergencies, and it is widely used by public health organisations during public health crises.
eSeminar: Research papers that make a difference: discussing research waste, reproducibility and impactby Iveta Simera, the EQUATOR Network
Dr Iveta Seimer, Deputy Director of the UK EQUATOR Centre, discusses research waste, reproducibility, and how to use reporting guidelines to make an impact. Poor reporting seriously affects the integrity of health research literature and critically limits the use and impact of published studies.
Video of Professor Peter Horby, the University of Oxford, on how he and his team set up clinical trials in the heart of the Ebola outbreak.
East African Leaders Join Together to Develop Country-Specific Plans for Point-of-Care Testing.
The CONSORT (CONsolidated Standards of Reporting Trials) 2010 guideline is intended to improve the reporting of parallel-group randomized controlled trial (RCT), enabling readers to understand a trial's design, conduct, analysis and interpretation, and to assess the validity of its results. This can only be achieved through complete adherence and transparency by authors. This series explores how an abstract can be improved through use of the CONSORT guidelines.
Professor Lang talks about doing difficult trials in difficult places - including malaria and ebola trials.
Postnatal growth standards for preterm infants: the Preterm Postnatal Follow-up Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
The first international stnadards for monitroing the growth of preterm babies have now been published in the Lancet Global Health (October 2015).
Whilst our understanding of drug resistant Plasmodium falciparum is quite well understood, the extent and nature of resistance in Plasmodium vivax parasites is for the most part unknown.
To promote high-quality post graduate (PG) research, Clinical Epidemiology and Global Health plans on publishing a supplement issue showcasing Post Graduate Medical Research.A pre-requisite for the submission is that the first author must be a PG student. A certificate from the departmental head stating that it is from PG thesis (or original research independent of the thesis but conducted during the PG residency) should be submitted along with the letter to the Editor.
What did we know before this research?The border between Thailand and Cambodia is the world’s epicenter of cases of multi-drug resistant Plasmodium falciparum , the most dangerous malaria species. Recently, cases of resistance to artemisinin have been documented in the region and triggered efforst to contain further spread.
What we did we know before this research?In Africa it’s common practice to overdiagnose malaria, which means that very often patients are given ACT drugs simply because they present fever. Not only this leads to the waste of expensive drugs, but it also means that patients don’t receive treatment for their actual illness.
Evidence shows that in many African regions, including Ghana, malaria is massively over-diagnosed. This means that patients who are not diagnosed with malaria by tests that identify malaria parasites in the blood are still considered to have the disease and therefore receive anti-malarial treatment.
The World Health Organization recommends artemisinin-based combination therapy (ACT) as the first-line treatment for malaria. This consists of combining two drugs: artemisinin (which derives from the artemisia plant) and a partner drug (one of existing antimalarials). If taken alone rather than combined, they are considered monotherapies and are less effective.
Scientific title: Strategies for optimizing the accurate elicitation of patient-reported data relating to drug safety What did we know before this research?During clinical trials, research teams use various information that participants tell them. These include the occurrence of new, possibly harmful or unpredicted side effects (known as adverse events or adverse drug reactions), the patients’ medical history and which other medicines they are taking.
Scientific title: Interactions between the antimalarial combination artemether/lumefantrine and antiretroviral therapy including nevirapine or lopinavir/ritonavir in HIV-infected adults What did we know before this research?Several African countries are heavily affected by both HIV/AIDS and malaria. The World Health Organization and ministries of health in most endemic countries recommend the use of artemisinin-based combination therapy (ACT) for malaria and antiretroviral combination treatments (ART) for HIV/AIDS, and such treatments have become increasingly available.
Scientific title: Determining sub-national intervention coverage and malaria impact estimates in young children and older age groups using a continuous Malaria Indicator Survey in Chikhwawa district, Malawi What did we know before this research?In areas where malaria transmission rates are moderate to high, the progress of malaria control is mainly evaluated using national household surveys such as Malaria Indicator Surveys (MIS), Demographic Health Surveys (DHS) or UNICEF Multiple Indicator Cluster Surveys (MICS). These are then complemented by data from Health Management Information Systems (HMIS).
Scientific title: Qualitative study on antimalarial drug use in the context of perceptions of ACTs and intra-household decision making in the Chikhwawa district of Malawi What did we know before this research?There are very effective antimalarial drugs available , but it is a challenge to ensure that they reach those that need them and that they are used appropriately.
What did we know before this research?International efforts to increase the use of artemisinin-based combination therapy (ACT) over the past decade have been based on the argument that this will lead to fewer malaria deaths. It has also been assumed that these drugs are safe even if used repeatedly. While there is no evidence to suggest concern, this has not been demonstrated directly in children under five years of age living in those areas.
In many malaria-endemic countries HIV/AIDS continues to spread, therefore an increasing number of patients need treatment for both infections at the same time. The WHO and ministries of health in many endemic countries recommend the use of artemisinin-based combination therapy (ACT) for malaria and antiretroviral combination treatments (ART) for HIV/AIDS. Such treatments have become increasingly available and research is being conducted into the clinical implications of taking ACT and ART concomitantly.
In many malaria-endemic countries HIV/AIDS continues to spread, therefore an increasing number of patients need treatment for both infections at the same time. The World Health Organization and ministries of health in many endemic countries recommend the use of artemisinin-based combination therapy (ACT) for malaria and antiretroviral combination treatments (ART) for HIV/AIDS. Such treatments have become increasingly available.
It is common practice in Africa to overdiagnose malaria, meaning that very often patients are given ACT drugs simply because they present fever. Given the high price of this type of medication, this approach becomes unsustainable. At the same time, it means that patients don’t receive treatment for their actual illness.
What did we know before this research?In sub-Saharan Africa it is common to overdiagnose and overtreat malaria, which means that patients who are not formally diagnosed with malaria are still considered to have the disease and therefore receive anti-malarial treatment. This leads to the waste of expensive drugs and increases the risk of developing drug resistance.
Scientific title: Infectious disease aetiologies of uncomplicated febrile illness in children <5 years of age in rural Zanzibar. As a result, Zanzibar has turned into a low transmission area with a decline of P. falciparum malaria among children with fever from approximately 30% to 1%, as well as a significant reduction of the crude child mortality.
Scientific title: Effectiveness of Malaria Rapid Diagnostic Tests in fever patients attending primary health care facilities in Zanzibar. Over the past decade, Zanzibar has adopted artemisinin-based combination therapy (ACT), long lasting insecticide treated nets and indoor residual spraying
Strategies for expanding access to quality malaria diagnosis in south-central Asia where malaria incidence is lowby ACTConsortium
Scientific title: An examination of ACT strategy in south-central Asia on P. falciparum malaria in a context where P. vivax is the major species. With the exception of Sub-Saharan Africa, most areas that are endemic for malaria have a combination of two species: Plasmodium falciparum and P. vivax. P. vivax is often the dominant species, accounting for a greater proportion of malaria cases.
Scientific title: A cost-effectiveness analysis of provider and community interventions to improve the treatment of uncomplicated malaria in Nigeria. Private-sector providers are a major source of malaria treatment in Nigeria, and many patients in Enugu state seek treatment at pharmacies and drug stores as well as public health centres.
Training manuals from REACT study in Cameroon. REACT Cameroon designed six training modules to support the introduction of malaria rapid diagnostic tests (RDTs). The manuals were used to train health workers at government and mission hospitals and health centres. The six modules are presented in two manuals
Cost-effectiveness of interventions to support the introduction of malaria rapid diagnostic tests in Cameroonby ACTConsortium
Scientific title: A cost-effectiveness analysis of provider interventions to improve health worker practice in providing treatment for uncomplicated malaria in Cameroon. Testing patients before prescribing medication is important, and should ensure patients receive the most appropriate treatment. This is important because unnecessary and inappropriate treatment has costs –incurred by patients, but also governments and donors working to control malaria.
Scientific title: IMPACT 2: Monitoring Interventions to Improve ACT Access and Targeting. It is generally agreed that artemisinin-based combination therapies (ACT) are the best treatment for malaria, but it is less clear how it should be deployed by national programmes.
Evaluation of the referral system implemented in registered drug shops, and impact on the public health systems in Uganda. Most malaria deaths occur within 48 hours after the first symptoms appear. In rural areas, where access to health centres is poor, home-based management of malaria can reduce mortality caused by the disease by up to 50%. This approach provides training to members of the community who are then able to give effective treatment near the patients’ home.
Introducing rapid diagnostic tests (RDTs) into the public and private health sectors in Uganda: a randomised trial to evaluate impact on antimalarial drug use. This study examines whether it is feasible and cost-effective to introduce RDTs into drug shops in Uganda in order to promote a rational and correct use of ACT drugs when managing cases of malaria.
This study evaluates whether the use of rapid diagnostic tests by community medicine distributors – with the aim to improve diagnosis and treatment of malaria in the community – is feasible, well accepted and cost-effective. This cluster randomized trial compares two approaches.
The PROCESS project is a complementary evaluation study that runs alongside the PRIME trial, which aimed to improve health centre management, fever case management and patient centred services at Ugandan health centres.
In Uganda and elsewhere, poor health services may limit appropriate management of fever cases and delivery of good quality care. Ultimately, this could contribute to the lack of progress on malaria control. In the formative research that preceded our intervention, we identified barriers and aspirations for quality health care. We used these results, together with evidence from studies elsewhere and the inputs of local stakeholders, to identify the most feasible interventions with the greatest potential for impact on health outcomes.
Guidance for non-economist audience to understand economic evaluations of health care interventions from the ACT consortium.
This article provides a helpful introduction to statistics as it relates to clinical research, explaining common terms and theories with examples and case studies. Powerpoint presentation also attached for further explanation.
Healthcare associated infections (HAI) are of important concern in patient care. This talk discusses Visual Analytics techniques which have been developed to help detect, monitor, analyse and understand trends, clusters and outbreaks of HAI.
The SWAT and SWAR programme is identifying issues about the methods of trials and systematic reviews about which there is sufficient uncertainty to justify research to support well-informed decision making about future designs and choices.
Schistosomiasis, is a chronic, debilitating disease. Uganda began a National Control Programme in 2003 with annual MDA of praziquantel. MDA on this scale provides strong selective pressures on the parasite population with an associated risk of drug resistance developing.
New guidelines help researchers undertaking systematic reviews and IPD meta-analyses to report their findings in a full and transparent manner.
Discusses the contribution of biodiversity and ecosystems to health care needs.
Research Nurse Jerome Ackeneck discusses what's involved in his role on a Cameroonian HIV Study
Consulting research stakeholders in Kenya on fair practice in research data sharing: Findings and Policy Implications - Dr Vicki Marsh
In this video, Professor Theonest Mutabingwa discusses the two key challenges that face developing countries to progress their malaria research.
Fetal Growth Standards for ultrasound measurements of head circumference (HC), bi-parietal diameter (BPD), occipito-frontal diameter (OFD), femur length (FL) and abdominal circumference (AC) are now available for download. For information about how to perform these measurements, or for other information on standards in ultrasound imaging, please see the ultrasound training toolkit.
In this video of a seminar delivered at the University of Oxford in June 2014, Professor Nicholas White talks about the challenge of antimalarial resistance.
Anders Björkman is Professor of Infectious Disease at the Karolinska Institute. In this video, Anders talks about how the efficacy of antimalarials is a major obstacle in the path towards full malaria elimination.
Joby George discusses his role as a research nurse based in India; what is involved, educational oprtions available, and what's important to him.
Shared panel discussion conducted about clinical research careers in India (conducted in Telugu and English), and article about research careers in India from Sreedhar Tirunagari
Are you a research scientist working in Global Health? Or an institution looking for partners to run a clinical trial? Site Finder is for you.
In this seminar from January 2014, Dr Jane Crawley talks about clinical standardisation in PERCH (Pneumonia Etiology Research for Child Health), a large case-control study of the causes of and risk factors for severe pneumonia.
Job interviews can be intimidating, but simply preparing well can make the difference between succeeding or failing, regardless of how nervous you are. In this article we pull together advice on how to prepare for job interviews and how to know what questions you’ll be asked.
Dr Nat Segaren - Medical Director of the Caris Foundation, presents on 'The Haiti National Early Infant Diagnosis of HIV Program'
New Public Management (public sector reforms which draw on business ideology) are increasingly seen in African ministries of health. This talk concentrates on the effects of NPM reform on Ethiopian hospitals and how efforts to be 'more business-like' have many unintended consequences for hospitals and patients.
Professor Bongani M Mayosi from the Department of Medicine, Groote Schuur Hospital & University of Cape Town describes the transofmation of the science cohort in South Africa.
In this seminar Professor Kevin Marsh describes how knowledge of immunity to malaria in humans has developed over the past thirty years and what impact this has for future research.
Professor Mike English explains how KEMRI-Wellcome are ''working with government to generate patient level data from a network of Kenyan hospitals as a platform for research'.
A birthday message for GHT and all its members from Mr Joby George, research nurse, India.
Notes on How to Survive a GCP Audit forum discussion based on the GCP Inspection Course (Global Health Network eLearning course)by A. Nair, C. Ovenstone, B. Wright, E. Allen, C. Reddy
ABRAID, new website of infectious diseases risk maps
In December 2013, an outbreak of Chikungunya virus (CHIKV) caused by the Asian genotype was notified in the Caribbean. The outbreak has since spread to 38 regions in the Americas. By September 2014, the first autochthonous CHIKV infections were confirmed in Oiapoque, North Brazil, and in Feira de Santana, Northeast Brazil. METHODS: We compiled epidemiological and clinical data on suspected CHIKV cases in Brazil and polymerase-chain-reaction-based diagnostic was conducted on 68 serum samples from patients with symptom onset between April and September 2014. Two imported and four autochthonous cases were selected for virus propagation, RNA isolation, full-length genome sequencing, and phylogenetic analysis. We then followed CDC/PAHO guidelines to estimate the risk of establishment of CHIKV in Brazilian municipalities. RESULTS: We detected 41 CHIKV importations and 27 autochthonous cases in Brazil. Epidemiological and phylogenetic analyses indicated local transmission of the Asian CHIKV genotype in Oiapoque. Unexpectedly, we also discovered that the ECSA genotype is circulating in Feira de Santana. The presumed index case of the ECSA genotype was an individual who had recently returned from Angola and developed symptoms in Feira de Santana. We estimate that, if CHIKV becomes established in Brazil, transmission could occur in 94% of municipalities in the country and provide maps of the risk of importation of each strain of CHIKV in Brazil. CONCLUSIONS: The etiological strains associated with the early-phase CHIKV outbreaks in Brazil belong to the Asian and ECSA genotypes. Continued surveillance and vector mitigation strategies are needed to reduce the future public health impact of CHIKV in the Americas.
We are a network of health and demographic surveillance systems (HDSSs) that provide a more complete picture. Since HDSSs collect data from whole communities over extended time periods, they more accurately reflect health and population problems in low- and middle-income countries (LMICs).
Links to the SPIRIT guidelines for protocol development and information about these guidelines - all free and open access.
Practical chart for health practitioners to use to assess newborn size (weight, length, head circumference) at birth against global standards. This version of the chart is being piloted within the University of Oxford hospital network, and plans to pilot in the INTERGROWTH-21st study sites and in Boston area hospitals are developing quickly. Practitioners can download and use this version of the chart freely. To connect with the INTERGROWTH-21st team regarding your experience with piloting this chart, or to request modifications to the chart (e.g. language; different institutional logo), please contact email@example.com.
Links to resources provided by iRIM (the Initiative on Research and Innovation Management) - free online presentations and tutorials relating to how to manage grants and perform administration of clinical research projects effectively.
Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field.
This paper is published in BioMedCentral, with link provided in this article. Building research capacity in health services has been recognised internationally as important in order to produce a sound evidence base for decision-making in policy and practice.
TWiGH takes a look at the past year and prospects for the coming months in Ebola affected countries.
We repeated, 10 years apart, the retrospective treatment-outcome study on 400 children with presumed malaria in the same area (Argemone mexicana decoction).
This WHO policy brief is part of a series on six global nutrition targets for 2025. This brief covers the third target: a 30% reduction in low birth weight. The purpose of the brief is to increase attention to, investment in, and action for a set of cost effective interventions and policies that can help WHO Member States and their partners in reducing rates of low birth weight. INTERGROWTH-21st Chief Investigators Stephen Kennedy and Jose Villar provided expert review of these strategies, contributing the unique perspective that data from the Project, and the resulting growth standards and tools as part of overall strategies for reducing rates of low birth weight in settings across the globe. The full policy brief series can be found here: http://www.who.int/nutrition/publications/globaltargets2025_policybrief_overview/en/
The INTERGROWTH-21st Project Neurodevelopment Package: A Novel Method for the Multi-Dimensional Assessment of Neurodevelopment in Pre-School Age Childrenby INTERGROWTH-21st
The INTERGROWTH-21st Neurodevelopment Package is a multi-dimensional instrument measuring early childhood development (ECD). Its developmental approach may be useful to those involved in large-scale ECD research and surveillance efforts. This paper describes neurodevelopment tools for preschoolers and the systematic approach leading to the development of the Package. The Package measures vision; cortical auditory processing; and cognition, language skills, behavior, motor skills, and attention in 35-45 minutes. Sleep-wake patterns are also assessed. Tablet-based applications with integrated quality checks and automated, wireless electroencephalography make the Package easy to administer in the field by non-specialist staff. http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0113360
A workshop on “Recent Trends and Career Development in Clinical Research –INDIA”, was organized at Bhaskara Auditorium on 19th November 2014 by SAMSKARA, a Non Profit Organization based at Hyderabad and The Global Health Network for the first time in Telangana.
Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailandby Pornpimon Adams et al
Hepatitis B vaccination status and Needle-stick and Sharps-related Injuries among medical school students in Nepal: a cross-sectional studyby Suraj Bhattarai, Smriti KC, Pranil MS Pradhan, Sami Lama, Suman Rijal
Background Hepatitis B is a dreadful infectious disease and a major global health problem. Health-care workers including clinical students are more vulnerable to such infections and non-sterile occupational exposures as their daily activities are closely related to patient's blood and body fluids.
On the 19th September 2014, Global Health Trials Southern Africa held its Annual Faculty Meeting, themed Clinical Trial Site Project Management. You can download the presentations from the talk and leave feedback here.
Professor Peter Piot, LSHTM, talks about Ebola and implications for Africa and understanding future epidemics at the Martin School, University of Oxford, 16th October 2014.
Ebola PPE guidelines - urgent need to revise WHO and CDC guidelines. This video shows an excerpt from keynote address 'The fuss about face masks', Professor Raina MacIntyre from the School of Public Health and Community Medicine, UNSW Australia.
Collaborative nursing research across academic and practice settings is imperative to generate knowledge to improve patient care. Models of academic/practice partnerships for nursing research are lacking. This paper reports data collected before and during a one-day retreat for nurse researchers and administrators from local universities and health care organizations designed to establish a regional nursing research partnership. Read the article here.
These logs from a trial in India, are comprised of essential checklists based on ICH-GCP guidelines enlisting all the important steps required for clinical trials. These checklists will serve as tools for clinical research professionals for executing clinical trials in time and effective manner.
International standards for fetal growth based on serial ultrasound measurements: the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Projectby INTERGROWTH-21st
Using the same methods and conceptual approach as the WHO child growth standards, the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project developed international growth and size standards for fetuses for clinical interpretation of routinely taken ultrasound measurements and for comparisons across populations.
Incidence of Road Traffic Injury and Associated Factors among Patients Visiting the Emergency Department of Tikur Anbessa Specialized Teaching Hospital, Addis Ababa, Ethiopiaby Bewket Tadesse Tiruneh, Berihun Assefa Dachew, Berhanu Boru Bifftu
The Ebola virus epidemic may well spread out of Africa. Dr Greg Martin takes a look at some of the variables that contribute to this risk and discusses some steps that should be taken.
This extensive toolkit was developed by TDR, and explains how to conduct implementation research. This toolkit was designed to help people learn a standard process that would lead to results that could be compared across regions and countries. It is designed to help identify system bottlenecks and the stakeholders to be involved, formulate appropriate research questions, conduct the research and develop a plan for implementing the study results.
On the 8th of July 2014 The Global Health Network launched the Global Health Research Process Map, the first digital toolkit designed to enable researchers anywhere in the world to conduct rigorous global health research.
Aspectos esenciales en la realización de investigación clínica no patrocinada comercialmente en el Peru - Workshop Reportby Centro de Salud Global - Tumbes, Universidad Peruana Cayetano Heredia
El taller titulado “Aspectos esenciales en la realización de investigación clínica no patrocinada comercialmente en el Perú”, se llevó a cabo en la ciudad de Lima, Perú el miércoles 11 de junio del 2014. La organización del Taller estuvo a cargo de El Centro de Salud Global – Tumbes de la Universidad Peruana Cayetano Heredia – UPCH y el Grupo de Proyectos...
Seven principles for strengthening research capacity in low- and middle-income countries: simple ideas in a complex worldby ESSENCE on Health Research Initiative
This good practice document of the ESSENCE on Health Research initiative is designed to provide broad guidance on how best to strengthen research capacity with the maximum possible benefit.
All of the forms that the INTERGROWTH-21st Project used to implement their studies can be downloaded here.
A programme set up by WHO together with major publishers to provide free or very low cost online access to the major journals to local, not-for-profit institutions in developing countries.
We have recently obtained permission to share some very interesting videos from Global Health Videos by Greg Martin. This video series covers issues relating to working in Global Health.
We have recently obtained permission to share some very interesting videos on The Global Health Network. The videos are from Global Health Videos by Greg Martin. You can follow more videos from him at his YouTube channel. This series of videos deal with Glolbal Health and Ethics.
In this collection of papers researchers dismiss the Omran model as relevant to contemporary developing countries and suggest the foundation for a new framework better suited for guiding and understanding past and future epidemiological changes within these populations.
Methods for Specifying the Target Difference in a Randomised Controlled Trial: The Difference ELicitation in TriAls (DELTA) Systematic Reviewby Jai K Das
Randomised controlled trials (RCTs) are widely accepted as the preferred study design for evaluating healthcare interventions. When the sample size is determined, a (target) difference is typically specified that the RCT is designed to detect. This provides reassurance that the study will be informative, i.e., should such a difference exist, it is likely to be detected with the required statistical precision. The aim of this review was to identify potential methods for specifying the target difference in an RCT sample size calculation.
Novel biomarkers for predicting intrauterine growth restriction: a systematic review and meta-analysisby INTERGROWTH-21st
Several biomarkers for predicting intrauterine growth restriction (IUGR) have been proposed in recent years. However, the predictive performance of these biomarkers has not been systematically evaluated. This objective of this paper is to determine the predictive accuracy of novel biomarkers for IUGR in women with singleton gestations. http://www.ncbi.nlm.nih.gov/pubmed/23398929
This paper assess the intra- and interobserver variability of fetal biometry measurements throughout pregnancy. Authors concluded that although intra- and interobserver variability increases with advancing gestation when expressed in milimeters, both are constant as a percentage of the fetal dimensions or when reported as a Z-score. Thus, measurement variability should be considered when interpreting fetal growth rates. http://www.ncbi.nlm.nih.gov/pubmed/22535628
A comprehensive classification system for preterm birth requires expanded gestational boundaries that recognize the early origins of preterm parturition and emphasize fetal maturity over fetal age. This paper explores the issues to consider in creating a classification system for preterm birth syndrome. http://www.ncbi.nlm.nih.gov/pubmed/22177186
The University of Oxford's Emerging Markets Symposium convened a gathering of health and nutrition experts, leading economists, and policymakers to discuss actionable priorities for improving maternal and child health and nutrition in emerging market countries. Universal adoption of the INTERGROWTH-21st Project's new global indicators at birth to capture differences in population-level nutritional and environmental exposures during pregnancy was one of their recommendations. http://ems.gtc.ox.ac.uk/sites/ems.gtc.ox.ac.uk/files/findings_and_recommendations_ems2014.pdf
Source: The Nuffield Department of Obstetrics and Gynaecology at the University of Oxford and the Geneva Foundation for Medical Education and Research Language: English, Spanish, Russian Overview: This course provides key information on postpartum hemorrhage for health care professionals. It covers basic clinical issues, as well as background information, such as the global burden of postpartum hemorrhage.The course is accompanied by key articles and documents for further reading. Certification is available to those who qualify.
Source: The Nuffield Department of Obstetrics and Gynaecology at the University of Oxford and the Geneva Foundation for Medical Education and Research Language: English, Spanish Overview: Course content includes both a basic module covering critical recommendations on prevention and treatment of pre-eclampsia/eclampsia (PE/E) for those unfamiliar with PE/E, and an advanced version for users interested in learning the evidence behind the recommendations, and is accompanied by key articles and documents for further reading. Certification is available to those who qualify.
Translating research into practice: the introduction of the INTERGROWTH-21st package of clinical standards, tools and guidelines into policies, programmes and servicesby INTERGROWTH-21st
This paper describes the approach to translating the findings, tools and resources generated by the INTERGROWTH-21st Project into practice. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12416/abstract
A rapid questionnaire assessment of environmental exposures to pregnant women in the INTERGROWTH-21st Projectby INTERGROWTH-21st
Impaired fetal growth and preterm birth are the leading causes of neonatal and infant mortality worldwide and there is a growing scientific literature suggesting that environmental exposures during pregnancy may play a causal role in these outcomes. This paper describes the creation of a global tool for screening pregnant women for environmental exposures in the Fetal Growth Longitudinal Study, a component of the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12430/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Seattle, USA. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12126/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Oxford, UK. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12033/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Muscat, Oman. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12043/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Nairobi, Kenya. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12045/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Turin, Italy. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12124/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Nagpur, India. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12058/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Beijing, China. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12044/abstract
This paper describes the implementation of the INTERGROWTH-21st Project in Pelotas, Brazil. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12046/abstract
The INTERGROWTH-21st Project presented a complex set of ethical challenges given the involvement of health institutions in geographically and culturally diverse areas of the world, with differing attitudes to pregnancy. This paper addresses how the research team dealt with some of those issues. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12030/abstract
Statistical considerations for the development of prescriptive fetal and newborn growth standards in the INTERGROWTH-21st Projectby INTERGROWTH-21st
This paper considers the statistical aspects of the three components of the INTERGROWTH-21st Project - the Fetal Growth Longitudinal Study, the Preterm Postnatal Follow-up Study, and the Newborn Corss-Sectional Study - as they relate to the construction of the INTERGROWTH-21st standards, in particular, the sample size. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12031/abstract
The INTERGROWTH-21st Project data management was structured incorporating both a centralise and decentralised system for the eight study centres, which all used the same database and standardised data collection instruments, manual and processes. This paper describes the data collection, entry and management processes that ensure that the data collected in the INTERGROWTH-21st Project were of exceptionally high quality. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12080/abstract
Given the multicentre nature of the INTERGROWTH-21st Project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21st Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21st participating centres. Thoughts about implementation strategies are presented. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12312/abstract
Anthropometric standardisation and quality control protocols for the construction of new, international, fetal and newborn growth standards: the INTERGROWTH-21st Projectby INTERGROWTH-21st
The INTERGROWTH-21st Project involved taking anthropometric measurements, including head circumference, recumbent length and weight of infants, and the stature and weight of parents. In a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detal, the anthropometric training, standardisation and quality control procedures used to collect data for these new standards. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12127/abstract
Anthropometric protocols for the construction of new international fetal and newborn growth standards: the INTERGROWTH-21st Projectby INTERGROWTH-21st
The INTERGROWTH-21st Project involved taking anthropometric measurements, including head circumference, recumbent length and weight of infants, and the stature and weight of parents. In a large, international, multicentre project, it is critical that all study sites follow standardised protocols to ensure maximal validity of the growth and nutrition indicators used. This paper describes, in detal, the selection of anthropometric personnel, equipment, measurement and calibration protocols used to construct the new INTERGROWTH-21st standards. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12125/abstract
Standardisation and quality control of ultrasound measurements taken in the INTERGROWTH-21st Projectby INTERGROWTH-21st
Meticulous standardisation and ongoing monitoring of adherence to measurement protocols during data collection are essential to ensure consistency and to minimise systematic error in multicentre studies. Strict ultrasound fetal biometric measurement protocols are used in the INTERGROWTH-21st Project so that data of the highest quality from different centres can be compared and potentially pooled. A central Ultrasound Quality Unit (USQU) has been set up to oversee this standardisation, training and quality control process. This paper describes the procedures used, which can form a model for research settings involving ultrasound measurements.
A unified protocol is essential to ensure that fetal ultrasound measurements taken in multicentre research studies are accurate and reproducible. This paper describes the methodology used to take two-dimensional, ultrasound measurements in the longitudinal, fetal growth component of the INTERGROWTH-21st Project. These standardised methods should minimise the systematic errors associated with pooling data from different sites. They represent a model for carrying out similar research studies in the future. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12313/abstract
This paper outlines the objectives, design and implementation of the INTERGROWTH-21st Project, a multicentre, multiethnic, population-based project conducted in eight geographical areas (Brazil, China, India, Italy, Kenya, Oman, UK and USA), with technical support from four global specialised units, to study growth, health and nutrition from pregnancy to early infancy. It aims to produce prescriptive growth standards, which conceptually extend the World Health Organization (WHO) Multicentre Growth Reference Study (MGRS) to cover fetal and newborn life. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12047/abstract
Conceptual basis for prescriptive growth standards from conception to early childhood: present and futureby INTERGROWTH-21st
Healthy growth in utero and after birth is fundamental for lifelong health and wellbeing. Current fetal growth charts in use are not true standards, since they are based on cross-sectional measurements of attained size under conditions that do not accurately reflect normal growth. The development of prescriptive intrauterine and newborn growth standards derived from the INTERGROWTH-21st Project provides the data that will allow us for the first time to establish what 'normal' fetal growth is. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12057/abstract
Zulfiqar Bhutta, Chair of the INTERGROWTH-21st Steering Committee, introduces the rationale for the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12032/abstract
Professor Sir Sabaratnam Arulkumaran, President of FIGO, introduces the methods of the INTERGROWTH-21st Project. http://onlinelibrary.wiley.com/doi/10.1111/1471-0528.12314/abstract
Preterm birth is a syndrome with many causes and phenotypes. We propose a classification system that is based on clinical phenotypes that are defined by >1 characteristics of the mother, the fetus, the placenta, the signs of parturition, and the pathway to delivery. Risk factors and mode of delivery are not included. There are 5 components in a preterm birth phenotype:
- Maternal conditions that are present before presentation for delivery,
- Fetal conditions that are present before presentation for delivery,
- Placental pathologic conditions,
- Signs of the initiation of parturition, and,
- The pathway to delivery
In 2009, the Global Alliance to Prevent Prematurity and Stillbirth Conference charged the authors to propose a new comprehensive, consistent, and uniform classification system for preterm birth. This first article reviews issues related to measurement of gestational age, clinical vs etiologic phenotypes, inclusion vs exclusion of multifetal and stillborn infants, and separation vs combination of pathways to preterm birth. http://www.ncbi.nlm.nih.gov/pubmed/22118964
Novel biomarkers for the prediction of the spontaneous preterm birth phenotype: a systematic review and meta-analysisby INTERGROWTH-21st
Being able to predict preterm birth is important, as it may allow a high-risk population to be selected for future interventional studies and help in understanding the pathways that lead to preterm birth. This paper investigates the accuracy of novel biomarkers to predict spontaneous preterm birth in women with singleton pregnancies and no symptoms of preterm labour. http://www.ncbi.nlm.nih.gov/pubmed/21401853
Reliable ultrasound charts are necessary for the prenatal assessment of fetal size, yet there is a wide variation of methodologies for the creation of such charts. This paper evaluates the methodological quality of studies of fetal biometry using a set of predefined quality criteria of study design, statistical analysis and reporting methods. Eighty-three studies met the inclusion criteria, and although multiple regression analysis shows that quality of studies has improved over time, there is considerable heterogeneity in study methodology still observed today. Standardisation of methodologies is necessary in order to make correct interpretations and comparisons between different charts. A checklist of recommended methodologies in proposed. http://www.ncbi.nlm.nih.gov/pubmed/22882780
Standardization of fetal ultrasound biometry measurements: improving the quality and consistency of measurementsby INTERGROWTH-21st
The objective of this paper was to assess whether a standardization exercise prior to commencing a fetal growth study involving multiple sonographers can reduce interobserver variation. http://www.ncbi.nlm.nih.gov/pubmed/22411446
Helpful, interactive eBook that aids those deciding how to further their career in research, or considernig whether to study as a post graduate.
This study protocol descibes the the objectives, design and implementation of the Fetal Growth Longitudinal Study (FGLS), the Preterm Postnatal Followup Study (PPFS), and the Newborn Cross Sectional Study (NCSS). Data from these studies inform new, international fetal and newborn growth standards and a package of accompanying resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/Intergrowth%20Protocol%20Sept%202009.pdf
This operation manual was used to implement the Fetal Growth Longitudinal Study (FGLS), which involved screening healthy women between 9 and 14 weeks gestation at the time of their early antenatal visit, and followed-up with standard clinical and 2D ultrasound examinations every 5 weeks, i.e. up to six times during a term pregnancy. The results of the FGLS inform new, international fetal and newborn growth standards and a package of supportive tools, guidelines and resources, including a new international equation for estimating gestational age through ultrasound. http://www.medscinet.net/Intergrowth/patientinfodocs/FGLS%20Manual%2015-09.pdf
This resource was used to train health professionals on how to record key data on pregnancies and deliveries for women participating in the Fetal Growth Longitudinal Study (FGLS) and Newborn Cross Sectional Study (NCSS). http://www.medscinet.net/Intergrowth/patientinfodocs/Pregnancy%20and%20Delivery%20Form%20Instructions.pdf
The INTERGROWTH-21st Project used this manual to standardize definitions, treatment and management recommendations of neonatal morbidities. http://www.medscinet.net/Intergrowth/patientinfodocs/Neonatal%20Manual%20Final.pdf
This handbook describes the methods used to perform accurate, precise and standardized anthropometric measurements for all components of the INTERGROWTH-21st study, including:
- height and weight of pregnant mothers
- birth weight, length and head circumference of newborns
- weight, length and head circumference of preterm babies
This protocol outlines the technique for measuring symphysis fundus height. http://www.medscinet.net/Intergrowth/patientinfodocs/Measurement%20of%20Symphysis%20Fundus%20Height.pdf
This protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.pdf
The aims of this manual are to ensure all trained ultrasonographers are familiar with the standardized way measurements should be taken for the purposes of using the INTERGROWTH-21st growth standards, including standardization of the way the equipment should be used, ultrasound findings are recorded, data is entered and transfered, and how to train, asesses and certify these standardized techniques. http://www.medscinet.net/Intergrowth/patientinfodocs/US%20Manual%20FINAL.pdf
The aim of this manual is to ensure all trained ultrasonographers are familiar with the standardized way crown-rump length measurements should be taken for the purposes of using the INTERGROWTH-21st fetal growth standards. http://www.medscinet.net/Intergrowth/patientinfodocs/CRLstandardisation_Website.pdf
This document is a selection of neurodevelopment assessment tests that were used in the INTERGROWTH-21st Project studies. It includes:
- Vision assessment
- Cortical auditory ERPs
- The INTER-NDA
- Assessment of sleep-wake cycle & daytime physical activity
This manual details the technique for administering the Cardiff Acuity Tests and Cardiff Contrast tests for vision assessment in children. http://www.medscinet.net/Intergrowth/patientinfodocs/Vision%20manual%20-%20July%202014.pdf
This manual details the technique for administering cortical auditory evoked response potential (ERP) tests for neurodevelopment assessment in children. http://www.medscinet.net/Intergrowth/patientinfodocs/Cortical%20auditory%20ERP%20manual%20July%202014.pdf
This manual details the technique for administering the INTERGROWTH-21st Neurodevelopment Assessment in children. http://www.medscinet.net/Intergrowth/patientinfodocs/INTER-NDA%20Manual%20July%202014.pdf
This manual details the technique for assessing sleep-wake cycles in children. http://www.medscinet.net/Intergrowth/patientinfodocs/Sleep-wake%20cycle%20assessment%20manual%20July%202014.pdf
Improving the capacity for quality clinical research in selected South African public health and/or academic intuitions through an enhanced Global Health Trialsby Elizabeth Allen - Regional Faculty Lead, Cordelia Leisegang - Regional Faculty Lead, Trudie Lang
The Global Health Trials South Africa Regional Faculty is currently running the following study, to improve the capacity for clinical research in South Africa by running an enhanced professional membership scheme and eLearning for study staff.
This article explains how to write a cover letter for a research job, tailored for each job and to maximise your chances of securing an interview. Examples and templates are given.
This article describes how to seek research jobs which will suiit you, and how to work out from the job description the best ways to apply and secure an interview.
This article gives practical advice about how to create an excellent research CV, and has links to many templates and advice articles from around the world, as well as information about how to use the Professional Membership Scheme to create a free, formatted GCP-standard CV for you which can be used for site files and job applications.
Complex realities: community engagement for a paediatric randomized controlled malaria vaccine trial in Kilifi, Kenya (Trials Article)by Vibian Angwenyi, Dorcas Kamuya - Expert Committee, Dorothy Mwachiro, Betty Kalama, vicki marsh, Patricia Njuguna, Sassy Molyneux
In this Trials paper, the authors share experiences of formal CE for a paediatric randomized controlled malaria vaccine trial conducted in three sites within Kilifi County, Kenya.
An introduction into and overview on the mathematics and practice of Bayesian (adaptive) clinical trials.
Planning, Monitoring and Evaluation Framework for Capacity Strengthening in Health Research - ESSENCE Good Practiceby ESSENCE on Health Research Initiative
The ESSENCE on Health Research initiative has created a good practice document on Planning, Monitoring and Evaluation Framework for Capacity Strengthening in Health Research.
Preparing for HIV Vaccine Trials in Nigeria: Building the Capacity of the Community and National Coordinating, Regulatory and Ethical Bodiesby Okpokoro, E, Osawe, S, Datong, P, Yakubu, A, Morenike Ukpong - Senior Contributor, Regional Faculty Committee, Orhii, P, Dakum, P, Garber, G, Abimiku A
This article, published in AIDS & Clinical Research, reports on a project aiming at building the capacity of regulatory agencies in Nigeria.
Often, morbidity management in NTDs is overlooked, due to its complexity and expensiveness.
A systematic review of barriers to and facilitators of the use of evidence by policymakers (BMC article)by Kathryn Oliver, Simon Innvar, Theo Lorenc, Jenny woodman, James Thomas
The gap between research and practice or policy is often described as a problem. To identify new barriers of and facilitators to the use of evidence by policymakers, and assess the state of research in this area, the authors present a systematic review.
Dissemination and Implementation Research: Intersection between Nursing Science and Health Care Deliveryby Vincent D
The editorial in Nursing Research and Practice discusses facilitators and barriers to knowledge and implementation of research findings in nursing.
Managing health worker migration: a qualitative study of the Philippine response to nurse brain drainby Roland M Dimaya, Mary M McEwan, Leslie A Currie, Elizabeth H Bradley
A qualitative study investigating causes and effects of nurse migration in the Philippines.
ESSENCE on Health Research have created a good practice document on research costing. It includes a review of the funding practices related to the definition and funding of direct and indirect costs.
New to monitoring clinical research trials? Ogundokun Olusegun outlines some of the responsibilities and tasks that the role involves, from revieiwing sites and managing research centers to the lifestyle pressures on the road.
Here you can read a report of the Lagos clinical research workshop held on 6th November 2013, as well as downloading the powerpoint slides from the day and seeing pictures.
This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.
A recent editorial in PLoS discusses the significance of transparency in reporting and publishing the studies and how scientific studies guidelines have evolved over time.
A new "improved traditional medicine" for malaria was developed in Mali, using an innovative approach. Instead of starting with classical laboratory research on plant phytochemistry and pharmacology, the authors first observed the clinical effectiveness of herbal remedies in current use. This approach enabled them to select what appeared to be the most effective remedy among 66 others.
Presentations from D Groups
The authors present the story of building a succesful research laboratory in Cameroon, including how they managed building up the infrastructure, equipment maintenance, staff training.
Researchers can often be tripped up by issues they encounter in developing regions and remote areas. Although no definitive answers are provided (there are just too many options and unknowns), the following issues should be considered when planning such a trial.
Despite published guidance on writing the abstract in the PRISMA Statement guiding the reporting of systematic reviews in general and elsewhere, evaluations show that reporting of systematic reviews in journal and conference abstracts is poor. Teh authors developed consensus-based reporting guidelines as an extension to the PRISMA Statement on good reporting of systematic reviews and meta-analyses in abstracts.
Powerpoint slides representing a comprehensive overview of some issues surrounding data management, including an overview of data management, the issue of coding, and regulations and guidelines. NEW ADDITIONS AUGUST 2013: Code of Federal Regulations part 11 - Guidelines on how to implement
Research misconduct is a global problem as research is a global activity. Wherever there is human activity there is misconduct, but we lack reliable data on the extent and distribution of research misconduct. This PLoS paper seeks to illustrate some examples of researsch misconduct in LMICs.
In this article, the authors illustrate five basic statistical concepts that can significantly impact the interpretation of the medical literature and its application to the care of patients, drawing examples from the vaccine literature: (i) consider clinical and statistical significance separately, (ii) evaluate absolute risks rather than relative risks, (iii) examine confidence intervals rather than p values, (iv) use caution when considering isolated significant p values in the setting of multiple testing, and (v) keep in mind that statistically nonsignificant results may not exclude clinically important benefits or harms.
Participant retention refers to keeping enrolled participants in a trial for the duration of the study. This article explains the concept of participant retention, and provides a template retention plan.
This is a nice guidance document on principles in electronic data capture from Industry perspective (FDA)
The practicality and sustainability of a community advisory board at a large medical research unit on the Thai-Myanmar borderby Khin Maung Lwin, Thomas J Peto, Nicholas J White, Nicholas P.J. Day, Francois Nosten, mparker, phaikyeong
Community engagement is increasingly promoted to strengthen the ethics of medical research in low-income countries. One strategy is to use community advisory boards (CABs): semi-independent groups that can potentially safeguard the rights of study participants and help improve research. However, there is little published on the experience of operating and sustaining CABs.
Transnational Working Group on Data management of the ECRIN, the European Clinical Research Infrastructures Network, present recommendations for quality and harmonisation for data management. In addition good data management practices in general are identified.
Critical issues in conducting non-commercially sponsored clinical research in South Africa: Meeting report 1st Feb 2013by Elizabeth Allen - Regional Faculty Lead, Lesley Workman - Senior Contributor, Cordelia Reddy
On 1st February 2013, Global Health Trials Southern African Regional Faculy held the first of its Clinical Trials Skills-Sharing Workshops in South Africa, hosted by the University of Cape Town. Here you can find the presentations from the day.
Report on a one-day skills sharing workshop for improved clinical trials and research in East Africa, hosted by UVRI/MRC, EACCR and Global Health Trials and held on 15th February 2013.
Clinical Data Management: Current status, challenges and future directions from industry perspectives.by Harry van Loen
This publication discsusses whether or not open-source clinical trial data management will improve the likelihood that good clinical trials are conducted in resource-constrained settings.
Repository on maternal child health: Health portal to improve access to information on maternal child health in Indiaby Jai K Das
This article describes a health portal developed in India aimed at providing one-stop access to efficiently search, organize and share maternal child health information relevant from public health perspective in the country.
The last decade has witnessed a substantial increase of multi-centre, public health-oriented clinical trials in poor countries. However, non-commercial research groups have less staff and financial resources than traditional commercial sponsors, so the trial teams have to be creative to comply with Good Clinical Practices (GCP) requirements. This article hopes to feed the reflection on the methodological and ethical aspects of clinical trials carried out in developing countries by North-South collaborative research groups.
This guidance article aims to provide a fully comprehensive, pragmatic guide for researchers of all roles, but especially ethics reviewers, to explain the details of each type of ethics review. The article is available in English, Spanish, Portuguese and Chinese, and has been kindly provided by www.ctmagnifier.org.
Whether breast cancer screening does more harm than good has been debated extensively. The main questions are how large the benefit of screening is in terms of reduced breast cancer mortality and how substantial the harm is in terms of overdiagnosis, which is defined as cancers detected at screening that would not have otherwise become clinically apparent in the woman's lifetime.
Research reporting guidelines are standard statements that provide guidance on how to report research methodology and findings. These are in the form of checklists, flow diagrams or texts. Most of the biomedical journals require authors to comply with these guidelines. Guidelines are available for reporting various study designs:
- CONSORT Statement (reporting of randomized controlled trials)
- STARD (reporting of diagnostic accuracy studies)
- STROBE (reporting of observational studies in epidemiology)
- PRISMA (reporting of systematic reviews)
- MOOSE (reporting of meta-analyses of observational studies)
This article is an introduction to cluster randomised trials.
The border between Thailand and Burma (Myanmar) is at the forefront of the global battle against malaria, and is an important site for research.
Clinical trials in India continue to be in the news, unfortunately a fair bit being negative coverage.
This bibliography is a work in progress and is regularly revised. We are currently updating it to link to any listed papers that are available via open access. If there are papers we're missing, or if you have other comments, please let us know by writing to firstname.lastname@example.org.
Health Researchers’ Ancillary Care Obligations in Low-Resource Settings: How Can We Tell What Is Morally Required?by Maria W. Merritt
Health researchers working in low-resource settings often encounter serious unmet health needs among participants. What is the nature and extent of researchers’ obligations to respond to such needs? Competing accounts have been proposed, but there is no independent standard by which to assess them or to guide future inquiry. I propose an independent standard and demonstrate its use.
Physician-researchers’ experiences of the consent process in the socio-cultural context of a developing countryby Aisha Y. Malik
This paper draws on empirical data obtained from interviews with physician-researchers in teaching hospitals of Lahore, Pakistan. The data identify social and cultural factors that affect the consent process for participants in research.
One fundamental ethical principle underpinning research ethics is that of respect for persons. It requires that researchers respect research participants’ autonomy, interests, and wishes, and act on the presumption that participants are the best judges of what their interests are (Nuffield Council on Bioethics 2002). This presumption obliges us to design consent processes for research that facilitate prospective participants’ free and informed decisions as to whether or not to participate in a study.
Aligning Community Engagement With Traditional Authority Structures in Global Health Research: A Case Study From Northern Ghanaby Paulina O. Tindana, Linda Rozmovits, Renaud F. Boulanger, Sunita V. S. Bandewar, Raymond A. Aborigo, Abraham V. O. Hodgson, Pamela Kolopack, James V. Lavery
This article explains the process of data management operations within clinical trials from start to finish.
2010 WHO Technical Report Series on the control of the leishmaniases.
Report from the sixth EDCTP forum in Ethiopia - Clinical trials in practice: how to achieve the best protection of the study subjects?by Raffaella Ravinetto
The report from the Satellite Event at the Sixth EDCTP1 Forum, Addis Ababa, Ethiopia United Nations Conference Centre, 11th October 2011: Clinical trials in practice: how to achieve the best protection of the study subjects?
This editorial describes the work of the WOMAN trial about post partum bleeding, and invites the participation of obstetricians, midwives and nurses from around the world to join an international collaborative effort to identify safe and effective treatments for post partum haemorrhage.
The Critical Path to TB Drug Regimens (CPTR) Initiative is seeking new trial sites for collaboration in planned phase I and II trials. Also available in French - click on the link and scroll down for French version.
These guidelines were developed following a Working Group on Disaster Research and Ethics (WGDRE) meeting in 2007 with the aim of developing ethical guidelines which would be applicable to post-disaster research, partiuclarly that performed in the developing world. We welcome any feedback from members.
Report from Workshop on Consent and Community Engagment in Health Research: Reviewing and Developing Research and Practice, Kilifi, Kenya Monday 28th February – Thursday 3rd March, 2011by Consent to and Community Engagement in Health Research Steering Committee
This is the Report from the "Consent to and Community Engagement in Health Research" workshop, which took place between 28 Feb - 03 Mar 2011 in Kilifi, Kenya. The workshop built upon an emerging collaboration between the Ethox Centre in Oxford, the Social and Behavioural Research Group at the Wellcome-KEMRI Unit in Kilifi, the Liverpool School of Tropical Medicine and the Mahidol - Oxford Tropical Medicine Research Unit in Thailand.
We present this clinical trial as a gold standard example. This study addressed a key question in the management of severely ill children. It was conducted to a very high standard across 3 African countries. This article links to a short film that explains how this trial can be an example to all researchers in resource-limited settings and shows that research can and should be done.
During the setting up of our trial in Cameroon we met several operational issues that we needed to overcome. For some of these issues we developed some tools and we have made them available here so that other research groups can use them in their clinical trials.
This articles explores some of the ethical issues arising in the context of collaborative global health research networks involving partners in developing and developed countries.
This paper, recently published on the Italian Journal of Tropical Medicine(Vol 15, N 1-4, 2010), reports on a debate that took place during the 6thEuropean Conference of Tropical Medicine in 2009, on some topics of greatinterest for GlobalHealthTrials.org: is there a global standard for clinicalresearch? Should standards be adapted in developing countries? How toencourage research while preventing the exploitation of vulnerableindividuals or groups? Five "debate questions" where addressed by ProfessorNick White and by Dr. Lumuli Mbonile, and discussed with the moderator(Raffaella Ravinetto) and the audience.
Health research: the challenges related to ethical review and informed consent in developing countriesby Raffaella Ravinetto
An article about a workshop that assessed ethical review and informed consent in vulnerable populations. This article aims to prompt a debate leading to better guiding principles on health research in constrained settings
The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
A set of 4 consent templates for clinical trials, interview studies, observation studies and sampling only studies.
This article explains how an East Africa Research Group have developed and applied a highly pragmatic an effective monitoring system. This group train research staff to monitor or perform QC on studies and then implement a system of reciprocal monitoring between studies. It is cost effective and works well.
An overview on trial registration. Here you can find out why trials need to be registered and what the difference is between all the registries - and how to register your study.
This article was written by a researcher from Sri Lanka and presents a very helpful overview on Biomedical Ethics. This article will be helpful to all levels of research staff and others who might want an accessible overview
This tool has been designed to help researchers run randomised controlled trials. This is available in both English and Spanish
The Trial Protocol Tool: a tool to help researchers to write a high quality protocol for a randomised controlled trial AVAILABLE IN SPANISH AND ENGLISH
Global Health Trials is a free open-access collaborative programme. We encourage clinical trials in difficult settings such as those with limited resources. We want to make it easier to conduct better trials and use the expertise and experience that already exisits by sharing best practice.
What is the definition of clinical trial monitoring? Who can be a monitor? What are the monitor's roles and responsibilities? Read on for some answers.
Some information about who we are and how we oversee this website.
An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.
Laboratory data is crucial in ensuring subject safety and determining the effectiveness of an investigational medicinal product. Here are some issues to consider for clinical trial laboratories in resource-poor settings.
Who should write up the results of the clinical trial? Are there guidelines on what should be included in the paper? This article answers these questions.
Ticking the last box: once the trial has ended it is important to ensure correct site closure and archiving of study files.
Considerations for pharmacovigilance and safety reporting.
Reciprocal or in-house monitoring schemes could be an alternative to expensive out-sourcing. Read on to find out more.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.
The effort invested in pre-trial planning and preparation more than pays off in terms of smooth operations, happy staff, happy participants, good recruitment and ultimately high quality data.
What is the definition of a clinical trial? Is there an international consensus? Read on to find out.
Clinical trials don't have to be expensive! Here are some tips for finding funding and drafting a realistic budget for your study.
Community sensitisation is a fundamental aspect of clinical trial operations anywhere in the world but is of particular relevance in the developing world. Share your experiences with other developing country researchers.
Good data management practices are essential to the success of a trial because they help to ensure that the data collected is complete and accurate. This article contains some tips to help you get started with data management.
Clinical trial regulations can be confusing and unwieldy to researchers. The intention of this section is to explain what regulations exist, where they apply and how to work through them in a sensible and pragmatic way to determine what is applicable to any given trial.
The informed consent process is fundamental to ensuring that clinical trials are conducted ethically. This article outlines some issues to consider.
Setting the right question is crucial to the success of a clinical trial and there are additional considerations for trials conducted in resource-limited settings.