期刊
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
卷 24, 期 1, 页码 19-41出版社
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2013.856022
关键词
Biomarker; Formation of subgroup; Interaction-to-overall effects ratio; Predictive of treatment effect; Subgroup-specific treatment effect hypothesis
资金
- RSR funds provided by the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration [05-02, 05-14]
This regulatory research provides possible approaches for improvement to conventional subgroup analysis in a fixed design setting. The interaction-to-overall effects ratio is recommended in the planning stage for potential predictors whose prevalence is at most 50% and its observed ratio is recommended in the analysis stage for proper subgroup interpretation if sample size is only planned to target the overall effect size. We illustrate using regulatory examples and underscore the importance of striving for balance between safety and efficacy when considering a regulatory recommendation of a label restricted to a subgroup. A set of decision rules gives guidance for rigorous subgroup-specific conclusions.
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