Pharmacy Times (8/29, Halpern) reports, “Essential trials supporting the approvals of FDA breakthrough therapy-designated drugs often used surrogate markers as primary end points – even when not approved through the accelerated approval pathway – and often lacked post-marketing studies to confirm a drug’s clinical benefit, according to the results of a study.” These discoveries “could lead to uncertainties and confusion for both clinicians and patients surrounding the use of breakthrough therapy-designated drugs and suggest that the requiring of post-marketing studies – regardless of approval pathway – could heighten certainty that key stakeholders have in the expected clinical benefit.” The findings were published in JAMA Network Open.
Related Links:
— “Frequent Use of Surrogate Markers Could Create Uncertainty for Breakthrough-Designated Drugs,”Luke Halpern, Pharmacy Times , August 29, 2024