ArticleTropical medicine & international health : TM & IH2025
Regulator experiences of trials during Ebola epidemics in Sierra Leone, Guinea, and the Democratic Republic of the Congo.
Article in Tropical medicine & international health : TM & IH, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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
1 citing paper in PubMed.
- Regulator experiences of trials during Ebola epidemics in Sierra Leone, Guinea, and the Democratic Republic of the Congo.Tropical medicine & international health : TM & IH · 2025Article
Corrections and comments
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Authors and funding
21 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDuring the 2014-2016 Ebola epidemic in West Africa and the Ebola outbreaks between 2018 and 2020 in the Democratic Republic of Congo, vaccines and other tools for prevention and treatment had to be taken through trials in exceptional circumstances using accelerated processes. MATERIALS AND
methodsWe interviewed members of ethics committees, health authorities, health professionals, and political authorities in the Democratic Republic of Congo in 2021 and held a workshop with ethics committee members and regulatory authorities from Sierra Leone and Guinea in 2022 in order to document their experiences of reviewing, approving, and regulating current and new studies during epidemics and outbreaks, and to document lessons learnt and their recommendations for the rapid review of clinical trial protocols during public health emergencies.
resultsSimilar barriers were identified in the three countries. These were related to weak legal frameworks and partnerships between ethics committees and regulatory bodies. Inadequate human resources, outdated standard operating procedures and guidelines, and lack of finance to support timely reviews were identified. We also noted a lack of awareness from politicians, scientists, and communities about the existence and functions of regulatory bodies/ethics committees, a lack of independence, and low interest in research. Opportunities identified by the institutions in the countries concerned included training ethics committee members and networking with experienced international platforms like the African Vaccine Regulatory Forum. Laws on regulating research have been updated in Sierra Leone and in Guinea, but not yet in the Democratic Republic of Congo.
conclusionRegulatory bodies have been facing many challenges in terms of a lack of a legal framework, a lack of finance, and a lack of support from politicians, scientists, and communities. Networking has been an opportunity for these regulators to mitigate these impediments.
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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.