Exploratory Subgroup Analyses in Clinical Research

Presents an overview of the issues and opportunities of subgroup analysis in clinical research and offers discussions of state of the art solutions This essential guide on subgroup analyses in the emerging area of personalized medicine covers the issues of subgroup analyses from a practical and a theoretical/methodological point of view. The practical part introduces the issues using examples from the literature where subgroup analyses led to unexpected or difficult-to-interpret results. On the technical side, subgroup analysis is linked to different approaches of statistical modeling, namely hierarchical and regression modeling. This allows for variance reduction by borrowing information from the full population in estimating a subgroup effect. It also links subgroup selection to model selection. This connection makes the techniques developed for model selection and reduction of selection bias applicable to subgroup analysis. Beginning with a history of subgroup analysis, Exploratory Subgroup Analyses in Clinical Research offers chapters that cover: objectives and current practice of subgroup analyses; pitfalls of subgroup analyses; subgroup analysis and modeling; hierarchical models in subgroup analysis; and selection bias in regression. It also looks at the predicted individual treatment effect and offers an outlook of the topic in its final chapter. The book: Focuses on the statistical aspects of subgroup analysis Filled with classroom and conference-workshop tested material Written by a leading expert in the field of subgroup analysis Complemented with a companion website featuring downloadable datasets and examples for teaching use Exploratory Subgroup Analyses in Clinical Research is an ideal book for medical statisticians and biostatisticians and will greatly benefit physicians and researchers interested in personalized medicine.