MPWG: Operations Sub-stream

Examining the operational and cross-functional realities of running master protocol trials in practice.

Part of the ASA-DahShu Master Protocol Working Group.

Overview

The Operations sub-stream focuses on the practical, cross-functional, and strategic challenges of implementing master protocol trials, including sponsor models, governance, site coordination, data standards, and lessons learned from real-world deployments.

Co-leads: Matthew Gribben (Amgen) and Marianne Chase (Mass General Brigham)

Current Focus Areas

  • Comparing the operational and strategic profiles of company-sponsored versus non-profit/academic-sponsored master protocol trials
  • Identifying best practices for cross-organizational governance of platform trials
  • Site engagement, patient recruitment, and operational burden in master protocol settings

Active Survey

The sub-stream is collecting responses on similarities and differences between pharma/biotech-sponsored and academic/non-profit-sponsored master protocols. Survey responses will support a submission to the 2026 Society for Clinical Trials (SCT) Annual Meeting.

To participate in the survey or learn more, contact the IDSWG Leadership Team.

Recent Publication

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

Get Involved

Contact the IDSWG Leadership Team to connect with the Operations sub-stream co-leads.

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