Blinded sample size recalculation in clinical trials with binary composite endpoints
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DOI: 10.1080/10543406.2016.1198371
Abstract: ABSTRACT We consider clinical trials with a binary composite endpoint where the trial is successful when a significant result is achieved for the composite or one prespecified main component. Appropriate sample size planning is challenging… read more here.
Keywords: trials binary; size; clinical trials; sample size ... See more keywords
Usefulness of the placebo lead-in design for clinical trials with binary outcomes
Sign Up to like & getrecommendations! Published in 2023 at "Clinical Trials"
DOI: 10.1177/17407745221140048
Abstract: Background: In placebo-controlled clinical trials to develop new drugs for the treatment of psychiatric or neurological disorders, a high and sometimes greater-than-expected placebo response makes it difficult to show the superiority of an investigational drug… read more here.
Keywords: trials binary; lead design; placebo lead; clinical trials ... See more keywords