How do clinical trials work, and who can participate?
Summary
Science Friday explores clinical trial eligibility and FDA drug approval standards with bioethicist Dr. Holly Fernandez-Lynch. The episode addresses why patients who have failed multiple treatments are often excluded from trials to ensure data clarity. It also examines the controversy surrounding accelerated approvals based on surrogate endpoints, such as the Alzheimer’s drug Aduhelm. Finally, the discussion covers the role of Institutional Review Boards and concerns about political interference in FDA decision-making.
Topics discussed
Sponsor messages from Progressive and Alienware
Intro: Chris's story of clinical trial rejection
Why trials exclude patients who failed other drugs
FDA approval standards: Safety and effectiveness
Clinical vs. surrogate endpoints in drug trials
Controversy over Aduhelm Alzheimer's drug approval
Break and transition to oversight discussion
Roles of sponsors, FDA, and Institutional Review Boards
Differences between academic and commercial IRBs
Political interference and changes at the FDA
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