Symposium 2014

"Advances in Clinical Trial Statistics: Multiplicity Adjustment and Sequential, Multiple Assignment, Randomized Trials" 

November 20th and 21st, 2014

The symposium will consist of an interdisciplinary series of presentations centered around two main themes: Multiplicity adjustment in clinical trials and the emerging use of Sequential, Multiple Assignment, Randomized Trials (SMARTs) for personalized medicine discovery. Biostatisticians and clinical scientists will describe recent advances in these two areas, ranging from practical aspects to methodological developments.
The symposium honors the late Yosef Hochberg, a graduate of the Department of Biostatistics at UNC-CH who made fundamental contributions in the area of multiple testing procedures.
A tutorial will lead off the portion of the program devoted to each theme, followed by two scientific sessions and two keynote lectures by leading researchers in that area. On the first day, a poster session/reception featuring presentations from both areas will be held following the scientific sessions.
This symposium will be of interest to clinical trial practitioners in industry and academia as well as others who have interest in recent and future directions in clinical trials and personalized medicine. We also hope the presentations and accompanying discussions will initiate future discoveries and progress in these important areas.
The symposium organizers gratefully acknowledge the support of Quintiles and Prosoft Clinical.

Agenda & Speakers

Day 1 (Thursday, November 20th, 2014)

7:30-8:00 AM Continental Breakfast
Advances in Clinical Trial Statistics: Multiplicity Adjustment
(organized by Fei Zou, UNC, and Dror Rom, Prosoft Clincial)
8:00-8:05 AM Welcome and Introduction
8:05-9:30 AM Tutorial: Introduction to Multiplicity in Clinical Trials
Frank Bretz, PhD, Novartis
9:30-9:40 AM Break
9:40-10:20 AM Keynote Lecture I
Yoav Benjamini, PhD, Tel Aviv University, "In Hochberg’s tradition: Selective Inference for Clinical Trials"
10:20-10:30 Break
10:30-11:45 AM Scientific Session I
Sanat Sarkar, PhD, Temple University, "Improving Holm's procedure using pairwise dependencies"
Joseph Heyse, PhD, Merck, "An Overview of Multiple Testing Procedures for Categorical Data"
Vered Madar, PhD, University of North Carolina, "Faster algorithm to control the Benjamini-Hochberg false discovery rate and its application for analysis of huge genomic data."
11:45 AM-12:45 PM Lunch
12:45-1:35 PM Scientific Session II
Michael Rosenblum, PhD, Johns Hopkins University, "Optimal, Two Stage, Adaptive Enrichment Designs for Randomized Trials, using Sparse Linear Programming"
Dror Rom, PhD, Prosoft Clinical, "The Closure Principle Revisited"
1:35-1:45 PM Break
1:45-2:25 PM Keynote Lecture II
Jiangtao Gou & Ajit Tamhane, PhD, Northwestern University, "Hochberg Multiple Test Procedure Under Negative Dependence"
2:25-2:45 PM Break
Advances in Clinical Trial Statistics: Sequential, Multiple Assignment Randomized Trials (SMARTs)
(organized by Eric Laber and Marie Davidian, NCSU; Michael Kosorok, UNC-CH)
2:45-2:50 PM Welcome and Introduction
2:50-4:15 PM "Tutorial: Getting SMART about Dynamic Treatment Regimes: A Conceptual Introduction"
Danny Almirall, PhD, University of Michigan
4:15-4:25 PM Break
4:25-5:05 PM Keynote Lecture III
Peter Thall, PhD, MD Anderson Cancer Center, "SMART Design, Conduct, and Analysis in Oncology"
5:05-6:15 PM Poster Session and Reception (combined topics)
6:15 PM Dinner (not provided)

Day 2 (Friday, November 21st, 2014)

7:30-8:00 AM Continental Breakfast
8:00-9:15 AM Scientific Session III
Yingqi Zhao, PhD, University of Wisconsin-Madison, "Estimation of Optimal Dynamic Treatment Regimes"
Lu Wang, PhD, University of Michigan, "Evaluation of Viable Dynamic Treatment Regimes in a Sequentially Randomized Trial of Advanced Prostate Cancer"
Eric Laber, PhD, North Carolina State University, "Sizing a trial for estimation of an optimal treatment regime"
9:15-9:25 AM Break
9:25-10:40 AM Scientific Session III (cont.)
Kelley Kidwell, PhD, University of Michigan, "Addressing the Challenges and Reaping the Benefits of SMARTs"
Abdus Wahed, PhD, University of Pittsburgh, "Baseline Covariate Adjustment in SMART Studies via Artificial Randomization"
Yichi Zhang, North Carolina State University, "Interpretable treatment regimes"
10:40-10:50 AM Break
10:50-11:30 AM Keynote Lecture IV
Susan Murphy, PhD, University of Michigan, "Micro-Randomized Trials & mHealth"
11:30-11:45 AM Closing remarks and adjournment of scientific session