Résumé
Au cours de l’épidémie de maladie à virus Ebola qui a affecté l’Afrique de l’Ouest en 2014–2016, la mise en place d’essais cliniques en vue de l’évaluation de stratégies thérapeutiques et de vaccins prometteurs mais non homologués est apparue comme une composante emblématique de la réponse globale à l’épidémie. La recherche clinique en situation épidémique causée par un agent infectieux hautement pathogène est un enjeu complexe en contexte de ressources limitées. En situation sanitaire extrême, priorité de soins et impératif d’interventions construites dans la perspective de l’évidence scientifique sont conciliables par une approche pragmatique et évolutive guidée par l’intégration de la recherche dans la démarche de soins et l’adaptation réactive aux critères contextuels. Ces enjeux sont portés aux scénarios à construire et anticiper au cours de la phase interépidémique inaugurée en 2016.
Abstract
In 2013, the world began to witness an unprecedented Ebola epidemic in West Africa that was smoldering by early 2016. Under this urgent circumstance, the global scientific community organized and made progress in identifying potential preventive countermeasures and therapeutics and accelerated the development of those promising interventions. Trials of experimental interventions soon emerged as a key component of the global response. Hence, an interdisciplinary issue ensued concerning how best to assess clinical safety and effectiveness of potential interventions prior to or concurrent with their broad use in humans. Key issues rely on the 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. Trials implemented during the outbreak crisis illustrates challenging inputs for producing scientific and ethical gains for the benefits of vulnerable populations in the context of an international emerging or re-emerging infectious disease event. This includes rapid implementation of clinical research studies from the early phase of the next global outbreak on the basis of practical and ready-to-apply innovative methodological framework built during interepidemic periods.
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Malvy, D. Produire de la science en situation de crise. Les traitements médicamenteux spécifiques de la maladie à virus Ebola en 2016 : leçons et perspectives. Bull. Soc. Pathol. Exot. 109, 262–271 (2016). https://doi.org/10.1007/s13149-016-0527-9
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DOI: https://doi.org/10.1007/s13149-016-0527-9