Usefulness of the placebo lead-in design for clinical trials with binary outcomes.
Clinical trials (London, England)（2023）
摘要
If the correlation of the placebo-placebo group is much higher than that of the placebo-drug group, the placebo lead-in design is advantageous in most cases but has an impact on an estimand in placebo nonresponders. Therefore, we do not recommend using the placebo lead-in design for clinical trials with binary outcomes.
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关键词
Placebo lead-in,binary outcomes,placebo responder,placebo response,relative efficiency
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