Usefulness of the placebo lead-in design for clinical trials with binary outcomes.
Gosuke HommaTakashi DaimonPublished in: Clinical trials (London, England) (2023)
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.