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.
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!
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)
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.
Workshop Report: Capacity building for clinical research in the face of disaster and conflict situations in middle and low income countriesby Glory Oluwagbenga Ogunfowokan - Regional Faculty Lead, morenike Ukpong, AUGUSTINE ONYEAGHALA - Senior Contributor, Global Health Trials Nigerian Regional Faculty
The Global Health Trials Nigerian Regional Faculty held a workshop entitled Capacity building for clinical research in the face of disaster and conflict situation in middle and low income countries at the National Hospital, Abuja, on the 28th January 2017. Here we provide the presentations and links discussed during the workshop.
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.
Epidemic curves are an important component of the public health and global health toolbox. Learn more about creating and interpretting them.
This article addresses the global burden of musculoskeletal trauma in particular in low and middle income countries.
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.
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.
This article discusses the designs used for two such clinical trials which have recruited patients in Liberia and Sierra Leone. General principles are outlined for trial designs intended to be deployed quickly, adapt flexibly and provide results soon enough to influence the course of the current epidemic rather than just providing evidence for use should Ebola break out again. Lessons are drawn for the conduct of clinical research in future outbreaks of infectious diseases, where the sequence of events may or may not be similar to the West African Ebola epidemic. The paper was published in Clinical Trials.
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.
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.
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.
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
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 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.
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.
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.
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.
Joby George discusses his role as a research nurse based in India; what is involved, educational oprtions available, and what's important to him.
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.
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 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.
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
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.
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.
Pragmatic and ethical research in disease outbreak settings: A one-day skills sharing workshop in Ghanaby Abena Konadu Yawson, Dr. Daniel Ansong, Kwaku Poku Asante
Global Health Trials and Kintampo Health Research Centre collaborated to run the workshop 'Pragmatic and ethical research in disease outbreaks' in November 2014. Here we provide a summary of the workshop and the presentations from the day.
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
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.
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.
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.
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.
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.
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
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
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
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
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
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
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 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.
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.
This guide, developed by the WHO and released in December 2013, aims to facilitate implementation research in LMICs.
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.
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.
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.
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.
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 explains the process of data management operations within clinical trials from start to finish.
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?
Article and slide sets about Global Health Trials, which can be used by anyone who may be interested in running seminars in their local institutions, or even organising workshops to further expand on the concept of sharing methods and knowledge to support clinical trials across disease areas.
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.
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.
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.
Regional faculties provide opportunity for increased professional networking and clinical trial skill sharing at a local level. The Global Health Regional Faculties are being set up to facilitate activities that will increase and support clinical research in specific regions this is achieved by sharing skills, knowledge and experience between disease areas, job roles and research sites. Examples are opening up spaces on training courses or for meetings, supporting exchange or observational site visits. This article explains how interested groups could set up a faculty in their region
The WHO invite comments on these new guidelines: Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants
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.
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
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.
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.
Considerations for pharmacovigilance and safety reporting.
The site initiation process is important as it ensures that all the logistics are organised and the site is ready to begin recruiting subjects.