The Clinical Evidence and Communication Unit
Improving FDA Approval Standards through Better Information and Evidence Generation
The Clinical Evidence and Communication unit aims to provide objective and measurable assessments of the clinical evidence for novel therapeutics in the premarket and postmarket phases, linking these outputs to specific policies that influence regulatory activities. The overarching goal is to drive more robust evidence generation for drug approvals through enhanced communication about drug benefits and increased quality and compliance with FDA-mandated studies in the postmarket phase. This work is generously supported by Arnold Ventures.
The interdisciplinary research studies are conducted through partnerships with the Department of Population Medicine, Division of Health Policy and Insurance Research at Harvard Medical School, the Department of Health Policy at the London School of Economics, and the Dartmouth Institute for Health Policy and Clinical Practice. The program is led by Dr. Florence Bourgeois in collaboration with Drs. Anita K. Wagner and Huseyin Naci.
Communicating Information about Benefits and Harms of New Drugs - April 10, 2025
To enable earlier market entry, most new drugs now reach patients on the basis of more uncertain evidence of their benefits and harms than in the past. Yet the regulated information available to clinicians, patients, and the public focuses largely on safety and rarely documents a drug’s benefits or the uncertainties surrounding them — information that is essential to judging a drug’s overall benefit–harm balance.
As the opening convening of this project, the HMCRS Clinical Evidence and Communication Unit hosted an invitational workshop on strategies to enhance the communication of regulated information about new drugs in the United States. Held on April 10th, 2025 in a hybrid format at Harvard Medical School, the workshop convened experts in drug regulation and science communication, together with clinician, patient, and payer representatives, to:
- Lay out the needs for improved regulated drug information
- Identify priority approaches for improving regulated drug information in the US, while also considering approaches underway in Europe
This early-stage workshop was designed to define priorities and shape the research agenda that guided the studies that followed.
Evidence Generation & Communication Project Symposium - May 12, 2026
Building on the priorities identified at the project’s 2025 workshop, the HMCRS Clinical Evidence and Communication Unit hosted a symposium to present its research and address gaps in the evidence underpinning new drugs as they move through the product lifecycle. Many new drugs now reach the market faster and on more limited evidence than before. While regulations call for further evidence to be generated after approval, this post-approval evidence often arrives late, is of variable quality, and does not reliably support clear communication about a drug’s benefits or the uncertainties surrounding its benefit–risk balance.
The symposium took place on May 12th, 2026 at the Harvard Medical School campus, convening a broad, cross-sector audience: academic researchers, policy advocates, regulators from the U.S. and abroad, clinicians, public and private payer representatives, and health communications experts. Where the workshop set the agenda, this symposium synthesized the Unit’s completed research and turned to the question of what should change. Its goals were to:
- Present and discuss the Unit’s research evaluating the quality, adequacy, and communication of the clinical evidence supporting newly approved drugs, including postmarket evidence generation and regulatory communication practices
- Identify priorities and strategies for strengthening evidence generation, transparency, and communication across the product lifecycle, to better support clinician, patient, payer, and regulatory decision-making
Publications from the Clinical Evidence and Communication Unit
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