Adaptive Enrichment Design — SCE Medical Oncology MCQ
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Correct answer: E — Permit prespecified biomarker-subgroup restriction after interim evidence review
Adaptive enrichment permits a prospectively specified restriction of later enrolment to a biomarker subgroup after an interim evidence review. Permit prespecified sample-size re-estimation after interim nuisance-parameter review: this is adaptive sample-size modification rather than enrichment of the target population. Permit prespecified dose selection after interim pharmacodynamic evidence review: dose adaptation changes treatment allocation rather than biomarker-defined eligibility. Permit prespecified dropping of a treatment arm after interim futility review: arm dropping is a different adaptive design feature. Permit prespecified endpoint weighting after interim event-rate review: endpoint adaptation does not define population enrichment.
Reference: Adaptive enrichment designs with a continuous biomarker (Published March 2023): https://pubmed.ncbi.nlm.nih.gov/35174875/; GMC good practice in research and consent (Effective April 2024): https://www.gmc-uk.org/professional-standards/the-professional-standards/good-practice-in-research-and-consent/good-practice-in-research