These guidance articles are peer reviewed and provided to give research teams high quality and trustworthy information on how to conduct a task or resolve an issue in the design, conduct or reporting of a clinical trial. Articles are accompanied by resources, such as a template or example documents. These are free for you to download and adapt for your study. Please acknowledge www.globalhealthtrials.org if you use these.
Neurodevelopmental milestones and associated behaviours are similar among healthy children across diverse geographical locationsby INTERGROWTH-21st
The latest findings from the international INTERGROWTH-21st Project, that has monitored healthy, urban children from educated families across four continents from early pregnancy to 2 years of age, show that human neurodevelopment is not influenced by the colour of an individual’s skin.
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!
The value of an embedded qualitative study in a trial of a second antidepressant for people who had not responded to one antidepressant: understanding the perspectives of patients and practititionersby Carolyn A. Chew-Graham, Thomas Shepherd, Heather Burroughs, Katie Dixon, David Kessler
We report a qualitative study embedded in a trial of second antidepressant for people who had not responded to one antidepressant, exploring the acceptability of a combination of antidepressants from the perspectives of both patients and practitioners, together with experiences of participating in a clinical trial.
Nurses’ perceptions towards the delivery and feasibility of a behaviour change intervention to enhance activity in patients at risk for cardiovascular disease in primary care: a qualitative studyby Heleen Westland, Yvonne Koop, Carin D. Schröder, Marieke J. Schuurmans, P. Slabbers, Jaap C. A. Trappenburg, Sigrid C. J. M. Vervoort
This study aimed to evaluate nurses’ perceptions towards the delivery and feasibility of the Activate intervention.
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.
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.
This page provides links to commonly used reporting guidelines for qualitative research, as well as articles which provide useful information about how to write about your research.
This paper provides a general guide to presenting qualitative research for publication in a way that has meaning for authors and readers, is acceptable to editors and reviewers, and meets criteria for high standards of qualitative research reporting across the board. We discuss the writing of all sections of an article, placing particular emphasis on how you might best present your findings, illustrating our points with examples drawn from previous issues of this Journal.
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 5th Edition (2016)
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.
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.
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.
Geoffrey Boulton lays out the case for sharing scientific data, and advises that the UK's Royal Society has established a working group to examine the implementation issues and to make recommendations.
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 shring.
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.
Experiences of using life histories with health workers in post-conflict and crisis settings: methodological reflectionsby Sophie Witter, Justine Namakula, Alvaro Alonso-Garbayo, Haja Wurie, Sally Theobald, Wilson Mashange, Bandeth Ros, Stephen Buzuzi, Richard Mangwi, Tim Martineau
In this paper, we examine our experience of using life histories to explore health system trajectories coming out of conflict through the eyes of health workers
The meaning of participation for children in Malawi: insights from children and caregivers” Child: Care, Health and Developmentby F. Nelson, C. Masulani‐Mwale, E. Richards, S. Theobald, M. Gladstone
The aim of this study is to explore what participation means for children (including those with and without disability) in rural Northern Malawi.
Challenges to the care of low birthweight babies in rural Southern Malawi: a qualitative study exploring perceptions and experiences of caregivers and health workersby Marianne Koenraads, John Phuka, Kenneth Maleta, Sally Theobald, Melissa Gladstone
This paper looks at the infants in Malawi who suffered from low birth weight, and asks the question: how can we improve the outcomes?
Strengthening close to community provision of maternal health services in fragile settings: an exploration of the changing roles of TBAs in Sierra Leone and Somaliland BMC Health Services Researchby Evelyn Orya, Sunday Adaji, Thidar Pyone, Haja Wurie, Nynke van den Broek, Sally Theobald
This article looks at Traditional Birth Attendants in Somaliland and Sierra Leone and at the important role they play in their commiunities.
Gendered negotiations for research participation in community based studies in Kenya: Implications for health systems researchby Kamuya DM, Molyneux CS, Theobald S
In this paper, qualitative research was used alongside large clinical community-based studies conducted on the Kenyan Coast to explore how gender and power relations within households and communities and between fieldworkers and communities shape consent processes and interactions.
Collaboration which allows protocol build, data collection and data sharing via free and open access web support.
Elizabeth Warren addresses the policy, privacy, and practical issues affecting data sharing in clinical trails.
Brigham and Women's Hospital–Harvard University's Multi-Regional Clinical Trials Center is designing a platform to link existing data-sharing platforms and communities and host data from investigators who want to share data but lack the resources to do so.
This article asks the question: how — and how much — to share, where and in what format data should be stored and accessed, and how to protect the privacy of the trial participants.
Data sharing guidance for CRUK researchers initiatives and repositories to support clinical rseacrhers with data management and sharing contentsby Cancer research UK
Cancer Research UK highlights some key initiatives and repositories which may provide tools and guidance for data sharing in the academic clinical trial field.
The University of Carolina offers a free eLearning course about data management and sharing.
The two-day symposium enabled an international group to meet and share experiences of the TwiCs design and to discuss plans for future research.
The University of Oxford's tips for data management planning.
The ACDM represents professionals working in the management of clinical data
The Bill and Melinda Gates foundation answers questions about their open access policy.
The ICMJE introduces it's vsion for a global research community in which sharing deidentified data becomes the norm.
A methodological approach for assessing the uptake of core outcome sets using ClinicalTrials.gov: findings from a review of randomised controlled trials of rheumatoid arthritisby Kirkham J, Clarke M, Williamson P
This study assess the uptake of the rheumatoid arthritis core outcome set using a new assessment method of calculating uptake from data in clinical trial registry entries.
Good Practice Principles for Sharing Individual Participant Data from Publicly Funded Clinical Trials (Version 1) GOOD PRACTICE PRINCIPLES FOR SHARING INDIVIDUAL PARTICIPANT DATA FROM PUBLICLY FUNDEDby Tudur Smith C
Thid guide offers good practice principles for sharing data from clinical trails
Guidelines for MRC research and management of data.
This study looks at the commitments made by companies to transparency of trials.
This article describes the heterogeneous RDR landscape. Further, the article outlines the features of re3data.org, and shows how this registry helps to identify appropriate repositories for storage and search of research data.
This article argues in favor of more widespread availability of data from clinical research.
This study analyses the solutions offered by generalist scientific data repositories.
The Yale Open Data Access (YODA) Project is one of several pioneering data-sharing models in use. It uses a “trusted intermediary” approach, in which an independent partner provides support, accountability, fairness, and transparency.
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.
ACCESS CV proposes a secure method of sharing sensitive patient data that balances the legitimate desire of the scientific community for data access with the responsibility to ensure high-quality analyses and protection of patients’ expectation of privacy.
Lisa Rosenbaum looks at both sides of the data sharing discussion.
Although some researchers remain wary about sharing data, recent policies and proposals mean that data sharing, in one form or another, is inevitable.
Sharing of data from clinical trials benefits patients by enabling new discoveries, meta-analyses, and confirmation of published results.
The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials.
Motivational interviewing (MI) is a client-centred method of intervention focused on enhancing intrinsic motivation and behaviour change. This article looks at MI in adults in primary care.
Effectiveness of a motivational interviewing intervention on weight loss, physical activity and cardiovascular disease risk factors: a randomised controlled trial with a 12-month post-intervention folby Sarah J Hardcastle, Adrian H Taylor, Martin P Bailey, Robert A Harley, Martin S Hagger
This is the first study to document the longer-term effects of adapted motivational interviewing, delivered in the primary care setting, on BMI, physical activity and related CVD risk factors.
This study determines how well authors comply with data sharing policies in Clinical Research Trails.
Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewersby Iain Hrynaszkiewicz, Melissa L Norton, Andrew J Vickers, Douglas G Altman
Iain Hrynaszkiewicz and colleagues propose a minimum standard for de-identifying datasets to ensure patient privacy when sharing clinical research data.
The double-edged sword of open access to research data.
This e-book covers benefits, barriers and models for data sharing.
The clinical research community is at an important crossroads about sharing data.
BioSharing: curated and crowd-sourced metadata standards, databases and data policies in the life sciencesby Peter McQuilton, Alejandra Gonzalez-Beltran, Philippe Rocca-Serra, Milo Thurston, Allyson Lister, Eamonn Maguire, Susanna-Assunta Sansone
BioSharing harnesses community curation to collate and cross-reference resources across the life sciences from around the world.
Data sharing statements for clinical trials: a requirement of the International Committee of Medical Journal Editorsby Taichman D, Sahni P, Pinborg A, Peiperl L, Laine C, James A, Hong S, Haileamlak A, Gollogly L, Godlee F, Frizelle F, Florenzano F, Drazen J, Bauchner H, Baethge C, Backus J
The ICMJ gives its vision for a global research community in which sharing de-identified data becomes the norm.
Data sharing is now a major theme in clinical research. However, effective, ethical sharing of clinical research data requires trust: research subjects must trust investigators to preserve their privacy, investigators must trust each other to give credit where credit is due, and the integrity of the entire research enterprise must be trusted by all.
Data Sharing & Transparency Initiative - The Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospitalby MCRT
The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT) aims to improve the integrity, safety, and rigor of global clinical trials.
Access to large, late-phase, cancer-trial data sets has the potential to transform cancer research by optimizing research efficiency and accelerating progress toward meaningful improvements in cancer care.
This article looks at the development of software to enhance the integration between patient-care practice and medical research.
Data sharing is as an expanding initiative for enhancing trust in the clinical research enterprise
Introduction to Research Electronic Data Capture (REDCap) and REDCap2SDTM, a Conversion Tool to Facilitate Clinical Research Data Sharingby Yamamoto K
A new tool for the capture and conversion of clinical data is introduced as a way to encourage reuse of data and to reduce workloads in new studies.
This article assesses the use of the BioLINCC by clinical researchers.
Clinical research data sharing: what an open science world means for researchers involved in evidence synthesisby Joseph S. Ross
This article looks at how data sharing could change and challenge design, conduct, and reporting of systematic reviews and meta-analyses for Clinical Research, as well as it's impact on those involved in evidence synthesis.
Statisticians are ambassadors for data sharing and are central to its success; this article looks at how the role is changing with new technologies and trends for data transparency.
The article poses the question: How would data sharing work best?
Development of an open-source, flexible framework for complex inter-institutional disparate data sharing and collaborationby Kirby C, Ambros P, Billiter D, London W, Mendonca E, Monclair T, Pearson A, Cohn S, Volchenboum S
The devolpment of a data sharing database makes it easier to harmonize and manage for data mining.
Technical and policy approaches to balancing patient privacy and data sharing in clinical and translational research.by Bradley Malin, David Karp, Richard H. Scheuermann
In this paper, we review several aspects of the privacy-related problems associated with data sharing for clinical research from technical and policy perspectives.
Open Science and Data sharing in Clinical research: Basing Informed Decisions on the Totality of Evidenceby Krumholz H
Basing Informed Decisions on the Totality of the Evidence
Application Description and Policy Model in Collaborative Environment for Sharing of Information on Epidemiological and Clinical Research Data Setsby Elias César Araujo de Carvalho, Adelia Portero Batilana, Julie Simkins, Henrique Martins, Jatin Shah, Dimple Rajgor, Anand Shah, Scott Rockart, Ricardo Pietrobon
This article describes a web appliaction for data sharing for clinical research.
Biomedical Data Sharing and Reuse: Attitudes and Practices of Clinical and Scientific Research Staffby Lisa M. Federer, Ya-Ling Lu, Douglas J. Joubert, Judith Welsh, Barbara Brandys
This study investigates these differences in experiences with and perceptions about sharing data, as well as barriers to sharing among clinical and basic science researchers.
The Changing Structure of Industry-Sponsored Clinical Research: Pioneering Data Sharing and Transparencyby Richard E. Kuntz
This article looks at the thriving interest in open science and the inevitable widespread adoption of data, and how the two can be managed.
This article looks at the complex issues behind data sharing in clinical trials.
Sharing clinical research data in the United States under the health insurance portability and accountability act and the privacy ruleby James D Miller
This article looks at the interaction in the USA between sharing data from clinical trails and the Privacy Rule adopted under the Health Insurance Portability and Accountability Act.
Sharing Privacy Protected and Statistically Sound Clinical Research Data Using Outsourced Data Storageby Geontae Noh, Ji Young Chun, Ik Rae Jeong
This article proposes a controlled secure aggregation protocol to secure both privacy and accuracy when researchers outsource their clinical research data for sharing
DICOM for quantitative imaging biomarker development: a standards based approach to sharing clinical data and structured PET/CT analysis results in head and neck cancer researchby Andriy Fedorov, David Clunie, Ethan Ulrich, Christian Bauer, Andreas Wahle, Bartley Brown, Michael Onken, Jörg Riesmeier, Steve Pieper, Ron Kikinis, John Buatti, Reinhard R. Beichel
Article on the devolpment of Imaging biomarkers and the need for data sharing for this.
The objective of this paper is to present the IMPACT Observatory as well as share some of its preliminary findings
Statistical controversies in clinical research: data access and sharing—can we be more transparent about clinical research? Let’s do what’s right for patientsby F. W. Rockhold
The question at the center of the open-science efforts for clinical trials should not be whether data should be shared, but rather how we can usher in responsible methods for doing so.
A review into new molecular markers potentially able to ameliorate the prognosis in thyriod cancer patients.
An article arguing that full transparency of clinical trial data is an essential prerequisite to achieving research integrity.
The Medical Research Council's policy on data sharing.
Best Practices for Ethical Sharing of Individual-Level Health Research Data From Low- and Middle-Income Settingsby Susan Bull, Phaik Yeong Cheah, Spencer Denny, Irene Jao, Vicki Marsh, Laura Merson, Neena Shah More, Le Nguyen Thanh Nhan, David Osrin, Decha Tangseefa, Douglas Wassenaar, Michael Parker
This article discusses the results of a systematic review and multisite qualitative study of key stakeholders’ perspectives on best practices in ethical data sharing in low- and middle-income settings.
In this paper, we share our experiences establishing data management systems and data-sharing infrastructure including a data-sharing policy, data access committee and related procedures.
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.
Involving Research Stakeholders in Developing Policy on Sharing Public Health Research Data in Kenyaby Irene Jao, Francis Kombe, Salim Mwalukore, Susan Bull, Michael Parker, Dorcas Kamuya, Sassy Molyneux, Vicki Marsh
Views on Fair Process for Informed Consent, Access Oversight, and Community Engagement
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.
A Qualitative Study of Experiences With and Attitudes Toward Data Sharing Among Research Staff and Community Representatives in Thailand.
A useful editorial by Ben Goldacre reviewing the current status of data sharing in clinical trials’
AREF-EDCTP have announced a joint call for a Preparatory Fellowship programme, due to be initiated in 2018.
King's College London is currently inviting applications for the post of Research Associate
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.
The Good Participatory Practice (GPP) Guidelines were developed by AVAC and UNAIDS. They provide trial funders, sponsors, and implementers with systematic guidance on how to effectively engage with all stakeholders in the design and conduct of biomedical HIV prevention trials. The guidelines are available in multiple languages. AVAC has also developed an array of supplementary GPP tools tools.
These recommendations are intended as a tool to help research staff and community representatives expand and deepen existing partnerships, and forge new ones, with the ultimate goal of facilitating effective community engagement in all aspects of clinical trials 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.
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.
Non-commercial clinical research plays an increasingly essential role for global health. Multiple partners join in international consortia that operate under the limited timeframe of a specific funding period.
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.
Mental Health Innovation Network (MHIN), a global community of mental health innovators, have released a toolkit which will help researchers communicate their findings to stakeholders. The toolkit is aimed at mental health research but can be applied to other types of research
New INTERGROWTH-21st International Postnatal Growth Standards for Preterm Infants - Charts availableby INTERGROWTH-21st
New INTERGROWTH-21st Postnatal Growth Standards charts for individual measurements of length, weight, head circumference, as well as a combined standards chart for length, weight and head circumference are now available for download here.
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.
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).
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.
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.
Trainer and Learner handbooks for workshops aimed at improving health centre management and patient centred services.
The TACT training manuals and patient leaflet were designed to support the use of malaria rapid diagnostic tests (RDTs). Here we provide Trainer/Trainee manuals in English and French, and visual patient information sheets in English, French and Swahili.
Guidance for non-economist audience on the importance of household costs related to seeking health care from the ACT Consortium.
Field trials of interventions against disease in low and middle income countries (LMICs) may be complex and expensive undertakings. This 3rd edition of the Field Trials Toolbox has been compiled by over 30 contributors with extensive direct experience in the design, conduct, and analysis of field trials in LMICs, and it attempts to document their accumulated experience for the guidance of those who might undertake field trials of health interventions. It can be read in its entirety as an introduction to the field and/or can serve as a reference volume during each of the different stages of planning, conducting, and analysing a field trial.
Grant applications differ substantially depending on the individual funding organisation, and each funding organisation has its own organisational aims, which are important to understand when you are considering which grant to apply to. In this article we provide practical tips and information for writing grant applications, which can be applied to grant applications of all sorts, from fellowships to large funding applications.
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.
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
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.
In celebration of Global Health Trials' fifth birthday (May 11th 2015) Professor Trudie Lang, Principal Investigator of the programme, talks to us about why Global Health Trials was started, why people should share their experience, and what the future holds.
Strengthening capacity to apply health research evidence in policy making: experience from four countriesby Sarah Hawkes, Bhupinder K Aulakh, Nidhee Jadeja, Michelle Jimenez, Kent Buse, Iqbal Anwar, Sandhya Barge, M. Oladoyin Odubanjo, Abhay Shukla, Abdul Ghaffar, Jimmy Whitworth
Little experience of strengthening the capacity of policy makers in low- and middle- income countries has been published to date. This article describe the experiences of five projects (in Bangladesh, Gambia, India and Nigeria) - author available to comment!
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
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 firstname.lastname@example.org.
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.
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.
This protocol outlines the technique for taking a pregnant woman's blood pressure. http://www.medscinet.net/Intergrowth/patientinfodocs/BP%20protocol.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 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
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.
Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopiaby Sam Franzen
New BMJ Open article: “Understanding the investigators: a qualitative study investigating the barriers and enablers to the implementation of local investigator-initiated clinical trials in Ethiopia” This article was written by the research team at Global Health Trials in collaboration with researchers from Ethopia, Sri Lanka and Peru. The research was initiated in response to the low volume of clinical trials conducted by investigators in Low and Middle Income Countries.
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.
We share a brief on the MCL shared at at the Women Deliver Conference 2013.
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.
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.
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.
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.
A Skills Sharing Workshop took place in Blantyre on 2nd October 2012. Presentations given on the day are shown here.
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)
The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.
A range of downloadable templates and tools for Clinical Research, including monitoring checklists, budget spreadsheets, informed consent forms, SOPs and so on.
This article is an introduction to cluster randomised trials.
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 email@example.com.
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.
This article explains the process of data management operations within clinical trials from start to finish.
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.
It is a recommendation of some IRB/ECs that back translation is included as a necessary step for the translation of some clinical trial documentation, including informed consent documents. This article explains the reasons for back translation, and takes you through how to effectively perform this step, including explaining how to find a suitable translator for the task.
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
An example of a academic research centre resolving the issue of clinical trial data management Peer reviewed by members of the data management expert committee for this programme.
This tool has been designed to help researchers run randomised controlled trials. This is available in both English and Spanish
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.
An overview of different types of clinical trial oversight committees, including steering committees and data safety monitoring committees.
Coming soon! A paper series on clinical trial design for tropical diseases. Read more here and get involved!
Project management ensures that the project does not veer off its intended pathway. This begins in planning, all the way through initiation to completion. Read the full article to learn more.
Clinical trial governance encompasses sponsorship, contracts, finance, confidentiality, trial insurance and professional indemnity and scientific and ethical review. You can find guidance and template documents relating to all of these topics throughout GlobalHealthTrials.org or you can contribute your own material to help others.
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.
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.