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A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever

Article scientifique 2022 Anglais

Résumé

BACKGROUND: Only one recommendation currently exists for the treatment of Lassa fever (LF), which is ribavirin administered in conjunction with supportive care. This recommendation is primarily based on evidence generated from a single clinical trial that was conducted more than 30 years ago-the methodology and results of which have recently come under scrutiny. The requirement for novel therapeutics and reassessment of ribavirin is therefore urgent. However, a significant amount of work now needs to be undertaken to ensure that future trials for LF can be conducted consistently and reliably to facilitate the efficient generation of evidence. METHODOLOGY: We convened a consultation group to establish the position of clinicians and researchers on the core components of future trials. A Core Eligibility Criteria (CEC), Core Case Definition (CCD), Core Outcome Set (COS) and Core Data Variables (CDV) were developed through the process of a multi-stakeholder consultation that took place using a modified-Delphi methodology. RESULTS: A consensus position was achieved for each aspect of the framework, which accounts for the inclusion of pregnant women and children in future LF clinical trials. The framework consists of 8 core criteria, as well as additional considerations for trial protocols. CONCLUSIONS: This project represents the first step towards delineating the clinical development pathway for new Lassa fever therapeutics, following a period of 40 years without advancement. Future planned projects will bolster the work initiated here to continue the advancement of LF clinical research through a regionally-centred, collaborative methodology, with the aim of delineating a clear pathway through which LF clinical trials can progress efficiently and ensure sustainable investments are made in research capacity at a regional level.

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Olayinka, A., Bourner, J., Akpede, G., Okoeguale, J., Abejegah, C., Ajayi, N., Akude, C., Ayodeji, O., Bausch, D., Clerck, H., Dan-Nwafor, C., Dunning, J., Erameh, C., Eze, J., Formenty, P., Gillesen, A., Jalloh, S., Jaspard, M., Jegede, T., Maïkéré, J., Malvy, D., Ogbaini-Emovon, E., Ojo, O., Okogbenin, S., O’Neill, K., Orji, M., Owhin, S., Ramharter, M., Samuels, R., Shehu, N., Merson, L., Salam, A., Kayem, N., Horby, P., Ihekweazu, C., Olliaro, P. (2022). A standardised Phase III clinical trial framework to assess therapeutic interventions for Lassa fever. https://doi.org/10.1371/journal.pntd.0010089

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Auteur(s)

Adebola Olayinka Josephine Bourner George O. Akpede Joseph Okoeguale Chukwuyem Abejegah Nnennaya Anthony Ajayi C Akude Oluwafemi Ayodeji Daniel G. Bausch Hilde De Clerck Chioma Dan-Nwafor Jake Dunning Cyril Erameh JN Eze Pierre Formenty Annelies Gillesen Sulaiman Jalloh Marie Jaspard Tolulope Jegede Jacob Maïkéré Denis Malvy Ephraim Ogbaini-Emovon Olalekan Ojo Sylvanus Okogbenin Kwame O’Neill Maria-Lauretta Orji Sampson Omagbemi Owhin Michael Ramharter Robert J. Samuels Nathan Y. Shehu Laura Merson Alex P. Salam Nzelle Delphine Kayem Peter Horby Chikwe Ihekweazu Piero Olliaro

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