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Updated: May 4, 2026

Using SCOPE to Identify Potential Regulatory Motifs in Coregulated Genes
Published on: May 31, 2011
A regulatory perspective on essential considerations in design and analysis of subgroups when correctly classified
Sue-Jane Wang1, H M James Hung
1a Office of Biostatistics, OTS/CDER , Food and Drug Administration , Silver Spring , Maryland , USA.
Abstract:
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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