A joint Working Group with ASA and BSWG advancing the design, analysis, and implementation of master protocol clinical trials through five active sub-streams.
Master Protocols (ASA-DahShu MPWG)
Overview
The ASA-DahShu IDSWG Master Protocol Working Group (MPWG) is a joint effort co-chaired by Cindy Lu (AstraZeneca) and Robert Beckman, M.D. (Georgetown University), operating under the American Statistical Association, DahShu IDSWG, and Bayesian Scientific Working Group umbrella.
The MPWG focuses on the methodology, regulatory landscape, and operational implementation of master protocols, covering basket, umbrella, and platform trials that evaluate multiple treatments or patient populations within a single overarching study framework.
Sub-streams
The MPWG operates through five active sub-streams. Click any card to learn more about the sub-stream’s focus, members, and current work.
Methodology & Concept
Bryan McComb, Ph.D. (Pfizer) · Courtney Henry, Ph.D. (GSK)
Framework development, simulation methodology, estimand considerations, and the conceptual foundations of basket, umbrella, and platform trial design. New members actively welcome.
Regulatory
Peter Mesenbrink (Novartis)
Monitoring FDA and EMA guidance, coordinating regulatory engagement, and maintaining the systematic literature review of master protocol trials. Volunteers needed for full-text review.
Basket Trials
Robert A. Beckman, M.D. (Georgetown University)
Confirmatory basket trial design, simulation-based evaluation, and real-world data applications. 17-member team spanning pharma, academia, and regulatory backgrounds.
Operations
Matthew Gribben (Amgen) · Marianne Chase (Mass General Brigham)
Cross-functional and strategic challenges of running master protocol trials. Active survey comparing company-sponsored and non-profit-sponsored platform trials, supporting a 2026 SCT submission.
Patient Engagement On Hold
Lead: TBD, reconvening January 2026
Integrating patient and caregiver perspectives into master protocol trial design from the earliest stages. Seeking a new sub-stream lead.
Current Projects
- Book: Master Protocol Clinical Trial for Efficient Evidence Generation, co-edited by Robert A. Beckman and Zoran Antonijevic. 12 of 20 chapters submitted to publisher as of September 2025, nearing final publication.
- Survey (active): The Operations sub-stream is collecting responses comparing pharma/biotech-sponsored and academic/non-profit-sponsored platform trials. Responses will support a 2026 SCT submission. Contact Marianne Chase or Matthew Gribben to participate.
- Manuscripts in preparation: Three MPWG manuscripts currently in preparation, including a multidisciplinary summary targeting Contemporary Clinical Trials and a subgroup heterogeneity analysis across 36 Phase 3 trials.
- Systematic Literature Review update: Covering master protocol publications from 2020–2025. Volunteers needed for full-text review, contact Peter Mesenbrink.
Publications
- Wu Y, Lu C, Aregay M et al. Company Sponsored Platform Trials: Recommendations and Lessons Learned from Cross-Industry Interviews. Therapeutic Innovation and Regulatory Science (2025). doi:10.1007/s43441-025-00792-0
- Beckman RA, Collyar D, Cooner F et al. ASA BIOP section newsletter on ASA DahShu IDSWG Multidisciplinary Master Protocol Working Group. ASA Biopharmaceutical Section Newsletter, 30(2): 50–52 (2023).
- Huml RA, Collyar D, Antonijevic Z, Beckman RA et al. Aiding the adoption of master protocols by optimizing patient engagement. Therapeutic Innovation and Regulatory Science, 57: 1136–1147 (2023).
- Lu C, Beckman RA et al. Tumor agnostic approvals: insights and practical considerations. Clinical Cancer Research, 30: 480–488 (2024).
See the full publications list for additional MPWG papers.
Get Involved
New members are welcome across all sub-streams, with particular need in Methodology & Concept and Regulatory. Contact the IDSWG Leadership Team or reach out to the relevant sub-stream lead directly.
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