How Statisticians Really Think About Endpoints, Power, and FDA Review with Roseann White

Statistics influence almost every major decision in a clinical trial. In this episode, Roseann White, a retired biostatistician with more than 30 years of experience, joins the Clinical Trial Podcast to make biostatistics practical for clinical research professionals. Roseann explains what statistical significance really means, why clinical meaning matters, how to think about superiority and non-inferiority, and why sensitivity and specificity can confuse even experienced teams. We also discuss endpoint selection, statistical analysis plans, financial constraints, FDA disagreements, and the questions non-statisticians should ask earlier in the trial design process. This is a practical conversation for anyone involved in designing, conducting, analyzing, or interpreting clinical trials.