Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics
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; howeve...
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| Format: | Article |
| Language: | English |
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Centers for Disease Control and Prevention
2025-02-01
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| Series: | Emerging Infectious Diseases |
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| Online Access: | https://wwwnc.cdc.gov/eid/article/31/2/24-0251_article |
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| author | Josephine Bourner Michel Vaillant Alex Paddy Abdel Salam Marie Jaspard Camille Fritzell Shevin T. Jacob Tom E. Fletcher Michael Ramharter Nnennaya Ajayi Sylvanus Okogbenin Cyril Erameh Donald Grant Robert Samuels Oladele Oluwafemi Ayodeji Armand Sprecher Bronner P. Gonçalves Tansy Edwards Piero Olliaro |
| author_facet | Josephine Bourner Michel Vaillant Alex Paddy Abdel Salam Marie Jaspard Camille Fritzell Shevin T. Jacob Tom E. Fletcher Michael Ramharter Nnennaya Ajayi Sylvanus Okogbenin Cyril Erameh Donald Grant Robert Samuels Oladele Oluwafemi Ayodeji Armand Sprecher Bronner P. Gonçalves Tansy Edwards Piero Olliaro |
| author_sort | Josephine Bourner |
| collection | DOAJ |
| 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.
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| format | Article |
| id | doaj-art-c72abf2b69624e0dbf70c7c8fef5cbe7 |
| institution | DOAJ |
| issn | 1080-6040 1080-6059 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Centers for Disease Control and Prevention |
| record_format | Article |
| series | Emerging Infectious Diseases |
| spelling | doaj-art-c72abf2b69624e0dbf70c7c8fef5cbe72025-08-20T03:01:22ZengCenters for Disease Control and PreventionEmerging Infectious Diseases1080-60401080-60592025-02-0131291610.3201/eid3102.240251Adaptive Design for Phase II/III Platform Trial of Lassa Fever TherapeuticsJosephine BournerMichel VaillantAlex Paddy Abdel SalamMarie JaspardCamille FritzellShevin T. JacobTom E. FletcherMichael RamharterNnennaya AjayiSylvanus OkogbeninCyril EramehDonald GrantRobert SamuelsOladele Oluwafemi AyodejiArmand SprecherBronner P. GonçalvesTansy EdwardsPiero Olliaro 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. https://wwwnc.cdc.gov/eid/article/31/2/24-0251_articleLassa feverclinical trialsvirusesphase II/III multicenter randomized controlled platform trial |
| spellingShingle | Josephine Bourner Michel Vaillant Alex Paddy Abdel Salam Marie Jaspard Camille Fritzell Shevin T. Jacob Tom E. Fletcher Michael Ramharter Nnennaya Ajayi Sylvanus Okogbenin Cyril Erameh Donald Grant Robert Samuels Oladele Oluwafemi Ayodeji Armand Sprecher Bronner P. Gonçalves Tansy Edwards Piero Olliaro Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics Emerging Infectious Diseases Lassa fever clinical trials viruses phase II/III multicenter randomized controlled platform trial |
| title | Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics |
| title_full | Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics |
| title_fullStr | Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics |
| title_full_unstemmed | Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics |
| title_short | Adaptive Design for Phase II/III Platform Trial of Lassa Fever Therapeutics |
| title_sort | adaptive design for phase ii iii platform trial of lassa fever therapeutics |
| topic | Lassa fever clinical trials viruses phase II/III multicenter randomized controlled platform trial |
| url | https://wwwnc.cdc.gov/eid/article/31/2/24-0251_article |
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