Ajit Tamhane, Ph.D.

Multiple Testing in Clinical Trials

Abstract: In this talk I will give an overview of some multiple testing problems in clinical trials that I have worked on in recent years. These problems came to me through some consulting work and have led to interesting theoretical developments resulting in publications in the top journals in the field (listed below in the references).

First I will review some basic concepts in multiple testing such as familywise error rate control, closed testing, group sequential designs and graphical methods. Then I will apply these concepts to the general problem of hierarchical (gatekeeping) testing of primary and secondary endpoints in a group sequential clinical trial. I will consider in some detail three special cases of this general problem.

The focus of the talk will be the ideas behind the results and not the technical proofs. As such, this talk should be accessible to all.

References:

1. Tamhane, A. C., Mehta, C. R. and Liu, L. (2010), "Testing a primary and a secondary endpoint in a group sequential design," Biometrics, 66, 1174-1184.

2. Tamhane, A. C., Wu, Y. and Mehta, C. R. (2012), "Adaptive extensions of a two-stage group sequential procedure for testing a primary and a secondary endpoint (I): Unknown correlation between the endpoints," Statistics in Medicine, 31, 2027-2040.

3. Tamhane, A. C., Gou, J., Jennison, C. Mehta, C. R. and Curto, T. (2018), ``A gatekeeping procedure for testing a primary and a secondary endpoint in a group sequential design with multiple interim looks,'' Biometrics, 74. 40-48.

Bio:

Ajit Tamhane is Professor of Industrial Engineering & Management Sciences (IEMS) with a courtesy appointment in Statistics at Northwestern University.

He has published over 100 papers in peer-reviewed journals in the areas of multiple testing, design of experiments, ranking and selection procedures, chemometrics and other related areas. He has authored or coauthored four books and co-edited two volumes of research papers..

He is an elected fellow of the American Statistical Association (1991), the Institute of Mathematical Statistics (2010), the American Association for Advancement of Science (2013) and an elected member of the International Statistical Institute (2015).