Special issue of Journal of Biopharmaceutical Statistics 2014

Special issue of Journal of Biopharmaceutical Statistics on subgroup analysis in clinical trials (January 2014). For more information about this special issue, visit the Journal of Biopharmaceutical Statistics web site.

Guest editors

Dr. Sue-Jane Wang (U.S. Food and Drug Administration) and Dr. Alex Dmitrienko (Quintiles).


S.-J. Wang and A. Dmitrienko. Guest Editors’ Note: Special Issue on Subgroup Analysis in Clinical Trials.

R. Hemmings. An Overview of Statistical and Regulatory Issues in the Planning, Analysis, and Interpretation of Subgroup Analyses in Confirmatory Clinical Trials.

S.-J. Wang and H. M. J. Hung. A Regulatory Perspective on Essential Considerations in Design and Analysis of Subgroups Correctly Classified.

A. Koch and T. Framke. Reliably Basing Conclusions on Subgroups of Randomized Clinical Trials.

O. N. Keene and A. D. Garrett. Subgroups: Time to Go Back to Basic Statistical Principles?

G. G. Koch and T. A. Schwartz. An Overview of Statistical Planning to Address Subgroups in Confirmatory Clinical Trials.

B. A. Millen, A. Dmitrienko, and G. Song. Bayesian Assessment of the Influence and Interaction Conditions in Multipopulation Tailoring Clinical Trials.

J. O. Berger, X. Wang, and L. Shen. A Bayesian Approach to Subgroup Identification.

I. Lipkovich and A. Dmitrienko. Strategies for Identifying Predictive Biomarkers and Subgroups with Enhanced Treatment Effect in Clinical Trials Using SIDES.

R. Varadhan and S.-J. Wang. Standardization for Subgroup Analysis in Randomized Controlled Trials.

N. Stallard, T. Hamborg, N. Parsons, and T. Friede. Adaptive Designs for Confirmatory Clinical Trials with Subgroup Selection.

J. Krisam and M. Kieser. Decision Rules for Subgroup Selection Based on a Predictive Biomarker.


U.S. Food and Drug Administration. Guidance for industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products. December 2012.