Informing single-arm clinical trials with external controls

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Ruthie Davi
Nirosha Mahendraratnam
Arnaub Chatterjee
C. Jill Dawson
Rachel Sherman
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Randomized controlled trials are the accepted standard for evaluating investigational therapies, but such trials are sometimes not an option for reasons of ethics or feasibility. Here, we discuss opportunities to address evidence gaps by using historical clinical trial data and real-world data in external control arms for single-arm trials, as well as the associated challenges.
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页码:821 / 822
页数:1
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