Exploratory Subgroup Analyses in Clinical Research - Hardcover

by Gerd Rosenkranz (Author)

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, which have been interpreted differently by different stakeholders. On the technical side, the book addresses selection and selection bias variance reduction by borrowing information from the full population in estimating a subgroup effect. To this end, subgroup analysis will be linked to statistical modelling, and subgroup selection to model selection. This connection makes the techniques developed for model selection 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.

• 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.

Author Biography

GERD ROSENKRANZ spent nearly 30 years as a biostatistician in different roles and responsibilities in the pharmaceutical industry, mainly in preclinical and clinical development. After retiring from industry, he spent two years as visiting professor at the Medical University of Vienna and is now a statistical consultant. He is a member of the focus group on subgroup analysis by the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI), and a former Editor-in-Chief of the Wiley journal Pharmaceutical Statistics where he remains on the Editorial Board.