Symposium on Evidence Generation and Communication for New Drug Approvals

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

 

Presentations from Symposium Speakers:

Foluso Agboola - Health Technology Assessment in the Face of Evidence Uncertainty: Challenges and Priority Needs

Christopher Booth - Common Sense Oncology: Outcomes that Matter

Sara Eggers - Perspective on AA evidence generation and communication

Juan García Burgos - Research and Policy Contexts of Drug Evidence Evaluation and Communication

Michelle Tregear - When Approval Signals More Certainty than the Evidence Supports

Diana Zuckerman - Policy Perspective on FDA Approval Standards and Communicating Risks and Benefits