Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?

Westyn Branch-Elliman, Lisa Soleymani Lehmann, William E Boden, Ryan Ferguson, Paul Monach, Westyn Branch-Elliman, Lisa Soleymani Lehmann, William E Boden, Ryan Ferguson, Paul Monach

Abstract

Given the high case fatality rate of SARS-CoV-2, for which there is no cure and no vaccine, clinicians are forced to make decisions about how best to manage patients with limited high-quality evidence to guide treatment. Traditional randomized controlled trials provide strong experimental evidence, however, tend to be slow, inflexible, and have limited generalizability. Adaptive and pragmatic designs are an attractive alternative, which meet our ethical obligation during the SARS-CoV-2 pandemic to balance speed, agility, and generalizability with both prospective study and scientific rigor.

Conflict of interest statement

All authors have no conflicts of interest to report.

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Source: PubMed

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