• Denis Malvy and Groupe d'étude JIKI¥.
• B Acad Nat Med Paris. 2014 Nov 1; 198 (8): 1515-27.

AbstractAccomplishment of therapeutic clinical trials in the midst of an uncontrolled and devasta- ting epidemic in resource-poor communities is complex and challenging. Key issues rely to close collaboration between research and clinical teams involved in care in the field. Indeed, it is of prime importance to consider cultural dimensions when aiming to build trust within communities and flexibility to adapt trial procedures to field constraints. The JIKI trial, a sequential single-arm proof-of-concept trial, has been implemented in Guinea in 2014-2015 with the aim to evaluate the efficacy of the antiviralfavipiravir in decreasing mortality and tolerance in patients with acute Ebola virus disease. Research was integrated into care to inform clinical management of patients. This pioneer trial illustrates challenging inputs for producing scientific and ethical gains for the benefit of vulnerable populations in the context of an international emerging or re-emerging infectious disease event.

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