MPWG: Regulatory Sub-stream

Engaging with the regulatory landscape for master protocol trials and tracking global guidance developments.

Part of the ASA-DahShu Master Protocol Working Group.

Overview

The Regulatory sub-stream monitors and engages with FDA, EMA, and international regulatory guidance relevant to master protocol trial design. It also coordinates IDSWG input to regulatory public comment processes and maintains the systematic literature review of master protocol trials.

Lead: Peter Mesenbrink (Novartis)

Current Focus Areas

  • Monitoring FDA and EMA guidance on master protocols, adaptive designs, and complex innovative designs. The FDA issued a revised draft Master Protocols guidance in June 2026 (replacing the December 2023 draft, adding a new basket trials section), open for comment through August 24, 2026
  • Systematic Literature Review update, covering master protocol publications from 2020 to 2025 (volunteers needed for full-text review and data extraction)
  • Engaging with regulatory stakeholders on platform trial guidance development

Recent Activity

  • Invited panel discussion: “Platform Trials, Shaping the Regulatory Guidance for Future Innovation.” International Society for Biopharmaceutical Statistics (ISBS) Webinar, December 6, 2024
  • Completed abstract screening for the SLR update; full-text review is the next phase

Volunteer Opportunity

The SLR update requires volunteers for full-text review and data extraction. No specialist knowledge of master protocols is required, familiarity with systematic review methods is helpful. Contact the IDSWG Leadership Team or Peter Mesenbrink directly to participate.

Get Involved

Contact the IDSWG Leadership Team to connect with Peter Mesenbrink and the regulatory sub-stream.

Page last reviewed: