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

Branch-Elliman W, Lehmann LS, Boden WE, Ferguson R, Monach P. Pragmatic, adaptive clinical trials: Is 2020 the dawning of a new age?. Contemporary clinical trials communications. 2020 Sep 1; 19:100614.

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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.




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