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

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

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Abstract

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.

Original languageEnglish
Article numbere0010089
Pages (from-to)1-14
Number of pages14
JournalPLoS Neglected Tropical Diseases
Volume16
Issue number1
DOIs
Publication statusPublished - 1 Jan 2022
Externally publishedYes

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