Sample Size Re Estimation News Today

The Phase 2b SOOTHE and Phase 2a BLUEPRINT clinical trials are on track, with topline results expected in Q4 2021 - BELLUS Health Inc. a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of refractory chronic cough and other hypersensitization-related disorders, today reported its financial and operating results for the second quarter ending June 30, 2021. PROGRAM AND CORPORATE ...

Aligning Commercial Strategy And Statistical Design Da Volterra wanted to maximize the power of their clinical trial for scenarios with a smaller treatment effect, and were contemplating a Sample Size Re-estimation design. Unfortunately, with a strict enrollment limit of 1,100 patients, this particular study design produced only marginal gains in power over the fixed sample size design. The Sponsor’s Chief Medical Officer was not content to risk the success of their new drug on a suboptimal t...