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Pooling Different Placebos as a Control Group in a Randomized Platform Trial: Benefits and Challenges From Experience in the ACTIV-2 COVID-19 Trial
- 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;
- Hosey, Lara;
- Roa, Jhoanna;
- Patel, Nilam;
- Aldrovandi, Grace;
- Murtaugh, William;
- Cooper, Marlene;
- Gutzman, Howard;
- Knowles, Kevin;
- Bowman, Rachel;
- Giganti, Mark;
- Erhardt, Bill;
- Adams, Stacey
Published Web Location
https://doi.org/10.1093/infdis/jiad209Abstract
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.
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