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Surrogate Endpoints — SCE Medical Oncology MCQ

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ModerateClinical Trials & StatisticsSurrogate EndpointsSCE Medical Oncology

A clinical trial reports that its primary endpoint (PFS) is positive but overall survival data are immature (only 25% of expected OS events have occurred). The trial is published and the drug receives regulatory approval based on PFS. What is the regulatory concept at play?

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Correct answer: C — Surrogate endpoint — PFS is used as a surrogate for OS to enable earlier drug approval, with post-marketing OS data collection required

PFS is widely used as a surrogate endpoint for OS in oncology, enabling earlier drug approval. Regulatory agencies (EMA, FDA) accept PFS as a basis for approval (often accelerated/conditional approval) with requirements for post-marketing confirmation of OS benefit. The validity of PFS as an OS surrogate varies by cancer type and treatment class. The ESMO-MCBS and ASCO Value Framework help assess the clinical meaningfulness of PFS improvements. Concerns exist about approvals based on PFS alone without subsequent OS confirmation.

Reference: JRCPTB Curriculum; FDA Surrogate Endpoints Guidance; ESMO-MCBS; ICH E9