Potential Statistical Issues Between Designers and Regulators in Confirmatory Basket, Umbrella, and Platform Trials

Abstract

Colligno, et al¹, present an interesting, well‐written, and clear paper on the emerging innovations of platform and basket trials that will help move the science forward. Their paper represents their personal views, from their perspectives as the issues regulators face in the review of these innovative trial designs and structure. My views on these regulatory statistical issues are from the perspective of a designer of platform (and basket) trials. I agree with much of the paper and appreciate the clarity to which these issues are presented. I point out a couple areas of complete agreement with the authors, but focus on areas where I disagree – or more appropriately think the topic deserves more discussion.