Platform, Basket, and Umbrella Trial Designs: Issues Around Health Technology Assessment of Novel Therapeutics

Abstract

Advancements in genomic and precision medicine have changed the way oncology clinical trials are designed. Compared to the traditional single tumour-based trial, master protocols, which are often classified as basket, umbrella, or platform trials, conduct studies on multiple subgroups under a single overarching protocol. This paper summarizes the discussion held during CADTH’s second webinar, which examined issues around health technology assessment of evidence generated using these trial designs. In this workshop, several experts were invited to present on the clinical, health economic, patient value, and ethical aspects associated with these new study designs. The discussion section of this paper summarizes the major points raised by the presenters, as well as questions from the audience and answers from the presenters.