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- Title
Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial.
- Authors
Moser, Carlee B; Chew, Kara W; Ritz, Justin; Newell, Matthew; Javan, Arzhang Cyrus; Eron, Joseph J; Daar, Eric S; Wohl, David A; Currier, Judith S; Smith, Davey M; Hughes, Michael D; Team, for the ACTIV-2/A5401 Study
- Abstract
Adaptive platform trials were implemented during the coronavirus disease 2019 (COVID-19) pandemic to rapidly evaluate therapeutics, including the placebo-controlled phase 2/3 ACTIV-2 trial, which studied 7 investigational agents with diverse routes of administration. For each agent, safety and efficacy outcomes were compared to a pooled placebo control group, which included participants who received a placebo for that agent or for other agents in concurrent evaluation. A 2-step randomization framework was implemented to facilitate this. Over the study duration, the pooled placebo design achieved a reduction in sample size of 6% versus a trial involving distinct placebo control groups for evaluating each agent. However, a 26% reduction was achieved during the period when multiple agents were in parallel phase 2 evaluation. We discuss some of the complexities implementing the pooled placebo design versus a design involving nonoverlapping control groups, with the aim of informing the design of future platform trials. Clinical Trials Registration. NCT04518410.
- Subjects
CLINICAL trial registries; PLACEBOS; COVID-19; CONTROL groups; TREATMENT effectiveness
- Publication
Journal of Infectious Diseases, 2023, Vol 288, pS92
- ISSN
0022-1899
- Publication type
Article
- DOI
10.1093/infdis/jiad209