Meeting of The Research, Development, and Regulatory Roundtable (R3) - The Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard

The Research, Development, and Regulatory Roundtable (R3) is a forum to discuss pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. Meetings convene policymakers, legal counsel, academicians, industry representatives, and global regulators. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

This hybrid meeting is open to sponsors of the Research, Development, and Regulatory Roundtable.

Topic: Operation Trialblazer

Abstract: On June 22, 2026, the U.S. Department of Health and Human Services (HHS) announced “Operation TrialBlazer”, a coordinated, department-wide initiative to restore U.S. leadership in clinical research and development (the “Initiative”). The Initiative spans multiple HHS divisions: the Food and Drug Administration (FDA), the National Institutes of Health (NIH) (including the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI)), the Advanced Research Projects Agency for Health (ARPA-H), the Office of the National Coordinator for Health Information Technology (ONC), and the HHS Office of Inspector General (OIG).

In this meeting of the R3, we will explore the policy underpinnings of the Initiative along with its most salient features, include the following:

• 1.  Motivations for the Initiative, including geopolitical and competitive concerns with the expansion of clinical trials in China and other ex-U.S. geographies
• 2.  HHS OIG’s request for information on Anti-Kickback Statute and Beneficiary Inducements CMP Exceptions for clinical trial participant remuneration
• 3.  Cross-agency collaboration on clinical trial participant-facing financial barriers
• 4.  Single IRB reform
• 5.  Electronic health record-based clinical trial recruitment
• 6.  FDA’s proposed expedited IND pilot program
• 7.  FDA’s revised draft guidances on substantial evidence of effectiveness and master protocols

For more information, please email at MRCT@BWH.HARVARD.EDU

Deliverables