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.
Templates from an investigator-led trial in Cameroon: the CAMPS trial (also available in French)
by Lawrence MbuagbawDuring 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.
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
Ethical criteria in clinical research in developing countries: is there a global standard?
by Raffaella RavinettoThis 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 countries
by Raffaella RavinettoAn 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
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.
Coming soon! A paper series on clinical trial design for tropical diseases. Read more here and get involved!