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Trial Design — SCE Medical Oncology MCQ

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ModerateClinical Trials & StatisticsTrial DesignSCE Medical Oncology

A clinical trial protocol states that the primary endpoint will be analysed 'after 350 events have occurred'. What type of endpoint design is this?

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Correct answer: C — Event-driven analysis — the trial continues until a pre-specified number of events (e.g. deaths or progressions) accumulate to ensure adequate statistical power

Event-driven trial designs are standard in oncology for time-to-event endpoints (OS, PFS). The trial continues until the pre-specified number of events occurs, regardless of calendar time. This ensures adequate statistical power, as the power of a log-rank test depends on the number of events, not the number of patients. Slow recruitment or lower-than-expected event rates can delay the analysis. This design is more efficient than calendar-time-based analysis.

Reference: JRCPTB Medical Oncology Curriculum; Friedman et al 'Fundamentals of Clinical Trials'; ICH E9