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Biomarkers — SCE Medical Oncology MCQ

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HardClinical Trials & StatisticsBiomarkersSCE Medical Oncology

An exploratory biomarker analysis reports a treatment benefit in TMB-high gastric cancer (p=0.03) but not TMB-low disease. The biomarker cutoff was chosen after inspecting the data, multiplicity was not controlled, and the treatment-by-TMB interaction is p=0.18. What is the defensible conclusion?

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Correct answer: A — The result is hypothesis-generating and does not establish TMB as a predictive biomarker

A predictive claim depends on a prespecified credible interaction, not significance in one subgroup and non-significance in another. A post hoc cutoff, unadjusted multiplicity and interaction p=0.18 make this hypothesis-generating. The interaction result does not prove equality, but neither does it support clinical cutoff adoption.

Reference: EMA guideline on multiplicity issues in clinical trials. https://www.ema.europa.eu/en/multiplicity-issues-clinical-trials-scientific-guideline