Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study

TotoMtunthama, Neema, Douglas, Elaine, Gmeiner, Markus, Barrett, Lynn K., Lindblad, Robert, Makhaza, Lumbani, Nedi, Wilfred, Phulusa, Jacob, Quinnan, Gerald V., Sawyer, Leigh A., Thole, Herbert, Van Voorhis, Wesley C. and Iroh Tam, Pui-Ying ORCID: https://orcid.org/0000-0002-3682-8892 (2020) 'Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study'. Trials, Vol 21, p. 680.

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Abstract

Background
An effective drug to treat cryptosporidial diarrhea in HIV-infected individuals is a global health priority. Promising drugs need to be evaluated in endemic areas which may be challenged by both lack of resources and experience to conduct International Committee of Harmonisation-Good Clinical Practice (ICH-GCP)-compliant clinical trials.

Methods
We present the challenges and lessons learned in implementing a phase 2A, randomized, double-blind, placebo-controlled trial of clofazimine, in treatment of cryptosporidiosis among HIV-infected adults at a single site in Malawi.

Results
Primary challenges are grouped under study initiation, study population, study implementation, and cultural issues. The lessons learned primarily deal with regulatory system and operational barriers, and recommendations can be applied to other human experimental trials in low- and middle-income countries, specifically in sub-Saharan Africa.

Conclusion
This study demonstrated that initiating and implementing human experimental trials in sub-Saharan Africa can be challenging. However, solutions exist and successful execution requires careful planning, ongoing evaluation, responsiveness to new developments, and oversight of all trial operations.

Item Type:	Article
Subjects:	QV Pharmacology > Drug Standardization. Pharmacognosy. Medicinal Plants > QV 771 Standardization and evaluation of drugs WA Public Health > Health Problems of Special Population Groups > WA 395 Health in developing countries
Faculty: Department:	Clinical Sciences & International Health > Malawi-Liverpool-Wellcome Programme (MLW)
Digital Object Identifer (DOI):	https://doi.org/10.1186/s13063-020-04620-8
Depositing User:	Stacy Murtagh
Date Deposited:	11 Aug 2020 10:43
Last Modified:	11 Aug 2020 10:43
URI:	https://archive.lstmed.ac.uk/id/eprint/15285

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