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Significant Interaction — SCE Medical Oncology MCQ

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HardClinical Trials & StatisticsSignificant InteractionSCE Medical Oncology

A researcher explains significant interaction test. An overall-negative trial has a positive biomarker-positive subgroup (HR 0.55, p=0.001) with p-interaction 0.003. Is the subgroup reliable?

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Correct answer: A — Significant p-interaction (0.003) supports genuine treatment-biomarker interaction; credible if pre-specified, biologically plausible, clinically meaningful — can support regulatory approval in biomarker-selected population

Significant p-interaction provides statistical evidence of genuine treatment-effect modifier. Combined with pre-specification, biological plausibility and meaningful effect size, supports biomarker-directed approval.

Reference: JRCPTB; Sun et al JAMA 2012; FDA Enrichment Guidance