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Evidence for New Medical Products: Implications for Patients and Health Policy

1200 New York Ave NW, Washington, DC

What Evidence is Essential for New Medical Products? Implications for Patients and Health Policy

This event is co-sponsored by the American Association for the Advancement of Science, the Division of Pharmacoepidemiology and Pharmacoeconomics of Brigham and Women’s Hospital/Harvard Medical School, and the National Center for Health Research.

Conference Focus

Better implementation of evidence-based medicine can improve the quality and cost-effectiveness of health care in the U.S.  This can be challenging in evaluating newly approved drugs and medical devices.  While current law requires that medical products be proven safe and effective, there is growing pressure to expedite access to promising therapies and to lessen the research and regulatory requirements for manufacturers. 

Unmet medical needs and patient demands call for a flexible approach to prescription drug and device regulation, but truncated premarket review may also lead to approval of products that are less  effective than expected or have unanticipated safety problems. This groundbreaking conference will review the growing body of research on the medical and public health implications of medical product approval criteria, and examine these findings in the context of patient outcomes, costs, and health policy.

Conference Recordings

Welcome Remarks
Keynote Addresses
Panel I. Evidence-Based Policy: Opportunities and Challenges
Panel II. Speed vs. Safety: Implications for Public Health of Changing Standards for Getting Products to Market
Panel III. Biomarkers, Surrogate Endpoints and Other Shortcuts that May or May Not Predict Health Outcomes
Panel IV. Post-Market Surveillance and Comparative Effectiveness Research
Panel V. What Kinds of Data are Needed/Used? A Policy Roundtable
Closing Remarks