US FDA Wants More ‘Rigor’ In Assessing Survival As An Oncology Safety Endpoint

 
• By Michael McCaughan

The agency wants sponsors to design clinical trials more carefully where overall survival is not the primary endpoint.

OS is no longer a reliable as a primary endpoint thanks to substantial improvement in cancer therapies. (Shutterstock)
Michael McCaughan

Read more by Michael McCaughan

Michael McCaughan is a founding member of Prevision Policy LLC, a leading provider of regulatory and reimbursement policy analysis for the biopharma industry. He was previously the Editor-In-Chief of The Pink Sheet and remains a contributor to the publication.

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