| Title: |
Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics. |
| Authors: |
Bourner, Josephine; Vaillant, Michel; Abdel Salam, Alex Paddy; Jaspard, Marie; Fritzell, Camille; Jacob, Shevin T; Fletcher, Tom E; Ramharter, Michael; Ajayi, Nnennaya; Okogbenin, Sylvanus; Erameh, Cyril; Grant, Donald; Samuels, Robert; Ayodeji, Oladele Oluwafemi; Sprecher, Armand; Gonçalves, Bronner P; Edwards, Tansy; Olliaro, Piero; WALC Work Package 2 Working Group |
| Publisher Information: |
Centers for Disease Control and Prevention (CDC) |
| Publication Year: |
2025 |
| Collection: |
London School of Hygiene & Tropical Medicine: LSHTM Research Online |
| Description: |
The current recommendation for treating Lassa fever with ribavirin is supported only by weak evidence. Given the persistent effects in areas with endemic transmission and epidemic potential, there is an urgent need to reassess ribavirin and investigate other potential therapeutic candidates; however, a robust clinical trial method adapted to Lassa fever epidemiology has not yet been established. We propose an adaptive phase II/III multicenter randomized controlled platform trial that uses a superiority framework with an equal allocation ratio and accounts for challenges selecting the primary end point and estimating the target sample size by using an interim analysis. |
| Document Type: |
article in journal/newspaper |
| File Description: |
text |
| Language: |
English |
| ISSN: |
1080-6040 |
| Relation: |
https://researchonline.lshtm.ac.uk/id/eprint/4677103/1/Bourner-etal-2025-Adaptive-design-for-phase2.pdf; Bourner, Josephine; Vaillant, Michel; Abdel Salam, Alex Paddy; Jaspard, Marie; Fritzell, Camille; Jacob, Shevin T; Fletcher, Tom E; Ramharter, Michael; Ajayi, Nnennaya; Okogbenin, Sylvanus; +9 more.Erameh, Cyril; Grant, Donald; Samuels, Robert; Ayodeji, Oladele Oluwafemi; Sprecher, Armand; Gonçalves, Bronner P; Edwards, Tansy ORCID logo; Olliaro, Piero; and WALC Work Package 2 Working Group (2025) Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics. Emerging infectious diseases, 31 (2). pp. 9-16. ISSN 1080-6040 DOI:10.3201/eid3102.240251 |
| DOI: |
10.3201/eid3102.240251 |
| Availability: |
https://researchonline.lshtm.ac.uk/id/eprint/4677103/; https://doi.org/10.3201/eid3102.240251 |
| Rights: |
cc_by_4 |
| Accession Number: |
edsbas.4CD1B080 |
| Database: |
BASE |