Randomization, Masking, and Allocation Concealment

Vance W. Berger received holds a doctoral degree in Statistics from Rutgers University. His professional career has included work in the pharmaceutical industry (Janssen Research Foundation, Theradex, and some consulting for Pfizer), work in two centers of the Food and Drug Administration (Drugs and Biologics), and review work for a number of statistical and medical journals. An active researcher, Dr. Berger wrote a book on the design and analysis of randomized clinical trials (focusing on randomization methods). He has also authored numerous book chapters and scientific articles appearing in the peer-reviewed literature, and has presented numerous invited lectures on this topic. Dr. Berger was the recipient of the 2006 Gertrude Cox Award, recognizing "a statistician making significant contributions to statistical practice" by the Washington Statistical Society.

Introduction. Randomization and Bias in Historical Perspective. A Review of Randomization and Allocation Concealment. Sympathetic Bias in Clinical Trials. Second Order Selection Bias in Randomized Trials. Third Order Selection Bias in Randomized Trials. A Survey of Randomization Methods in Recent Trials. A Comparison of Randomization Procedures. A Note on Unrestricted Randomization. The Case for Using Minimization To Prevent Selection Bias. Reporting of Randomization (Alexandra Winter. Graphical Representations of Randomization. Selection Bias in Studies with Unequal Allocation. The Evolution of the MTI Procedures. Automating the Maximal Randomization Procedure.