ArticleTrials2020
Conducting clinical trials in sub-Saharan Africa: challenges and lessons learned from the Malawi Cryptosporidium study.
Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.
- A landscape analysis of clinical trials and infant clinical trials in Kenya, Ethiopia, and Nigeria.Frontiers in epidemiology · 2024Pooled it
- Community-informed trial design and implementation to optimize recruitment and retention in low-income settings: lessons from rheumatic heart disease trials in Uganda.Frontiers in cardiovascular medicine · 2026Article
- COVID-19 and ethics in action: Insights from African research committees.Journal of public health in Africa · 2026Article
- Investigator-Initiated Clinical Pharmacokinetic Studies in Resource-Limited Settings: Minimal Requirements and Practical Guidance.Journal of clinical pharmacology · 2025Review
- Development, implementation, and evaluation of an innovative clinical trial operations training program for Africa (ClinOps).BMC medical education · 2025Article
- A compound analysis of medical device clinical trials registered in Africa on clinicaltrials.gov.Trials · 2024Review
- Article
- Regulatory approval of clinical trials: is it time to reinvent the wheel?BMJ global health · 2024Article
- Health inequalities in the management of chronic hepatitis B virus infection in patients from sub-Saharan Africa in high-income countries.JHEP reports : innovation in hepatology · 2023Review
- Implementation challenges and lessons learned from the STREAM clinical trial-a survey of trial sites.Trials · 2023Article
- The experience of disproportionate supplies of COVID-19 vaccines to Africa: the need for Africa to decolonize its public health response.The Pan African medical journal · 2023Article
- Defining clinical trial quality from the perspective of resource-limited settings: A qualitative study based on interviews with investigators, sponsors, and monitors conducting clinical trials in sub-Saharan Africa.PLoS neglected tropical diseases · 2022Article
- Promoting Best Practice in Cancer Care in Sub Saharan Africa.Frontiers in medicine · 2022Article
- Opportunities and Challenges in Developing aACS infectious diseases · 2021Article
- Operationalisation of the Randomized Embedded Multifactorial Adaptive Platform for COVID-19 trials in a low and lower-middle income critical care learning health system.Wellcome open research · 2021Article
- The status of neglected tropical diseases amidst COVID-19 in Africa: Current evidence and recommendations.Health promotion perspectives · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 3 institutions in 3 countries.
Funding
Abstract
backgroundAn 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.
methodsWe 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.
resultsPrimary 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.
conclusionThis 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.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.