SYMPOSIUM CELEBRATING 30 YEARS AT THE UNIVERSITY OF WISCONSIN

David L. DeMets, PhD

Max Halperin Professor of Biostatistics Department of Biostatistics and Medical Informatics

School of Medicine and Public Health University of Wisconsin, Madison

1325 Health Sciences Learning Center (HSLC)

Thursday, May 31, 2012

8:00 – 8:30 am           Registration/Continental Breakfast

                                   Video: Welcome and Session 1

8:30 – 8:40                 Welcome: Robert Golden, Dean, School of Medicine and Public Health

8:40 – 9:00                 Marvin Zelen, Lemuel Shattuck Research Professor of Statistical Science, Department of Biostatistics, Harvard School of Public Health

9:00 – 10:30               Session 1

      Janet Wittes: History of the NHLBI Biostatistics Branch and Its Role in the Early Development of Clinical Trials

      Lawrence Friedman: ITT and Anturane Trials

      Curt Furberg: Challenges in Documenting Drug Safety

      Nancy Geller: DLD’s Continued Influence at NIH

10:30 – 11:00              BREAK

                                   Video: Session 2

11:00 – 12:30 pm       Session 2

      Charles Hennekens: Aspirin in the Treatment and Prevention of Cardiovascular Disease: Past, Present, and Future

      Robert Califf: The Clinical Trials Enterprise: Getting Reliable Answers More Efficiently

      Marc Pfeffer: Safety Monitoring in Clinical Trials and the TREAT Trial

                                   Video: Session 3

1:30 – 3:00                 Session 3

      Susan Ellenberg: AIDS DSMB and Its Impact

      Frank Rockhold: IDMC Liability Concerns: Who Protects the Guardians?

      George Williams: The Nocturnal Oxygent Therapy Trial (NOTT): Lessons of Continuing Value

3:00 – 3:30                 BREAK

                                   Video: Session 4

3:30 – 5:30                 Session 4

      Anastasios “Butch” Tsiatis: Group Sequential Methods

      K.K. Gordon Lan: Alpha Spending Functions and Design of Clinical Trials

      Tom Fleming: Surrogate Endpoints

6:30-9:00                    Reception/Dinner

      Dinner Speaker: Jonas Ellenberg

Friday, June 1, 2012

8:00 – 8:30 am            Continental Breakfast

                                   Video: Day 2 Opening Talks

8:30 – 8:45                  Paul DeLuca, Provost, University of Wisconsin

8:45 – 9:00                  Philip Farrell, Professor Emeritus, UW Department of Pediatrics

9:00 – 9:15                  Marc Drezner, Senior Associate Dean for Clinical and Translational Research, Director, Institute for Clinical and Translational Research

9:15 – 9:30                  BREAK

9:30 – 11:00                 Session 5

       Charlie Casper: Running a Data Coordinating/Biostatistics Center

       Joshua Chen: Testing Superiority at Interim Analyses in a Non-Inferiority Trial

       José Pinheiro: Dose Finding Under Model Uncertainty: The MCPMod Approach

       Peng “Roger” Qu: Overview of Drug Development and Biostatistics in China

       David Reboussin: Monitoring Intervention X Subgroup Interactions, and a Simplified Approach to Analysis of Mediation

       Michelle Roth-Cline: Pediatric Ethics at the FDA: The Crossroads of Ethics, Medicine, Statistics, and Law

11:00 – 11:15               BREAK

11:15 – 12:15 pm         Session 6: Panel Discussion

       Chair: KyungMann Kim

       Panelists: DeJuran Richardson, Stephen Gange, Fred Yang, Xiaoyin “Frank” Fan, Zhengqing Li, Muhammad “Jalal” Jalaluddin

12:15 – 12:30              Closing Remarks: Paul Rathouz, Professor and Chair, UW Department of Biostatistics and Medical Informatics