BackgroundIn 2008, we created the ‘Switching The Poles’ Clinical Research Network, by joining the forces of non-commercial clinical research groups in Benin, Burkina Faso, Cambodia, Cuba, the Democratic Republic of Congo, Ethiopia, India, Indonesia, Nepal, Peru, Rwanda, The Gambia and Vietnam. Our aim was to strengthen capacity to conduct non-commercial clinical trials that comply with ethical/regulatory standards.MethodsOur capacity building initiatives were designed to directly benefit the implementation of clinical trials, including various EDCTP-sponsored projects, e.g. 4ABC (7 countries), PREGACT (4), Microbicide Safety Biomarkers (3) and Ring Plus (1). Our training, coaching and networking activities targeted young researchers from the South as well as research professionals who are traditionally ‘neglected’ in trainings, such as data managers and laboratory staff. There were several thematic packages: Good Clinical Practice (GCP), Good Clinical Laboratory Practice, data management (DM), monitoring, and informed consent.ResultsWe developed a theoretical and practice-based GCP training that was adopted by WANETAM Plus in 2013, and a set of standardised DM procedures. Data managers used to working on their own, now benefit from an e-platform (admitnetwork.org) for collaboration and peer advice. We started coaching clinical monitors, for facilitating reciprocal monitoring schemes. We publicly spoke out about ethical issues, e.g. ethical review of externally-sponsored trials, voluntariness in informed consent in vulnerable populations, and provided recommendations to the International Conference of Harmonization in its revision of GCP Guidelines. The inclusion of partners from so many diverse countries and settings resulted in cross-fertilisation and mutual learning. The Networks' small size facilitated interpersonal collaboration.ConclusionsOur experience shows that a relatively small, but focused international network provides an excellent platform for supporting young researchers across different professional disciplines and helps to strengthen capacity for clinical research. This approach has enabled partners in low- and middle-income countries to successfully conduct harmonised GCP-compliant clinical trials.
Background The Good Clinical Practices (GCP) codes of the World Health Organization and the International Conference of Harmonization set international standards for clinical research. But critics argue that they were written without considering the challenges faced by clinical researchers in low-and middle-income countries (LMIC). Methods We analysed the challenges met when conducting clinical trials in LMIC, including in several locations in sub-Saharan Africa and in EDCTP-funded trials. We compared these challenges to GCP guidance, in order to (a) verify if there are gaps between the international GCP codes and the field reality in LMIC, and (b) formulate recommendations for GCP improvement if needed. Results We identified shortcomings in the GCP guidance concerning three broad domains: ethical, legal and operational. We identified also eleven specific issues: the double ethical review of 'externally sponsored' trials; the informed consent in children; the informed consent in illiterate people; the informed consent comprehension; the definition of vulnerability; the post-trial access to communities; the role of communities as key stakeholders in research; the definition of sponsor; the guidance for contractual agreements; the clinical monitoring; the laboratory quality management systems; and the quality assurance of investigational products. For each specific issue, we formulated a recommendation for the improvement of GCP. Conclusions Clinical trials are increasingly conducted in LMICs, thus a comprehensive revision of GCP guidelines is needed, to ensure adequate guidance for researchers operating in these contexts, and to maximise protection of research participants. The revised GCP code should be strongly rooted in ethics, sensitive to different socio-cultural perspectives, and allow consideration of trial-and context-specific challenges. This can be only achieved if researchers, sponsors, regulators
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.