Platform trials and master protocols

Platform trials and master protocols

Presented by Thomas Jaki and James Wason

Master protocols are a class of efficient clinical trial designs that seek to answer multiple research questions within a single trial protocol and include platform, basket and umbrella trials. The advantages of using such designs are many, ranging from use of a shared trial infrastructure to reusing information within the study (e.g. using a single control group or borrowing of information).

In this course they provide an overview of statistical approaches to the design and analysis of Master protocols in a mixture of lectures and practical sessions. The following topics will be discussed:

·         A framework for designing multi-arm multi-stage platform trials

·         Methods for information borrowing with application to Basket and Umbrella trials

·         Software for Master protocols

·         Practical considerations when implementing a Master protocol