MPWG: Methodology & Concept

Advancing the conceptual and methodological foundations of master protocol clinical trial design.

Part of the ASA-DahShu Master Protocol Working Group.

Overview

The Methodology and Concept sub-stream focuses on the theoretical and applied foundations of master protocol design, including framework development, estimand considerations, simulation methodology, and the conceptual distinctions between basket, umbrella, and platform trial structures.

Co-leads: Bryan McComb, Ph.D. (Pfizer) and Courtney Henry, Ph.D. (GSK)

This sub-stream is undergoing a reboot under new leadership. New members are actively welcome.

Current Focus Areas

  • Developing a unified framework for classifying and comparing master protocol design types
  • Simulation methodology for evaluating operating characteristics of basket and platform designs
  • Estimand considerations specific to master protocol contexts
  • Methodological guidance on borrowing of information across sub-studies

Recent Activity

The sub-stream contributed to the multidisciplinary MPWG book (Master Protocol Clinical Trial for Efficient Evidence Generation, nearing publication) and is preparing manuscripts on master protocol methodology targeting Contemporary Clinical Trials.

Get Involved

This sub-stream is actively recruiting new members. Contact the IDSWG Leadership Team or reach out directly to the co-leads:

To get involved, email the IDSWG at asadahshuidswg@gmail.com and your message will reach the co-leads, Bryan McComb and Courtney Henry.

Page last reviewed: