Survival distributions impact the power of randomized placebo-phase design and parallel groups randomized clinical trials

OBJECTIVES: The study evaluated the power of the randomized placebo-phase design (RPPD)-a new design of randomized clinical trials (RCTs), compared with the traditional parallel groups design, assuming various response time distributions. In the RPPD, at some point, all subjects receive the experimental therapy, and the exposure to placebo is for only a short fixed period of time. STUDY DESIGN AND SETTING: For the study, an object-oriented …