Harvard Schering-Plough Workshop

Program

Thursday Morning, May 28

8:00 a.m. - Registration & Continental Breakfast
 

SESSION I - OVERVIEW & KEYNOTE LECTURE

Session Chair: James Ware
8:45       Welcome and Introduction Victor DeGruttola/
Tom Capizzi
9:00 Money, Ethics, Culture of Practice and Genetic Variation:Unresolved Issues in Globalization of Clinical Trials in 4 Dimensions Robert M. Califf

10:00 - 10:15 Break

SESSION II - CASE STUDIES

Session Chair: Thomas P. Haverty
10:15 The PEARLS Study, a Multinational Clinical Trial of HIV Treatment Thomas B. Campbell
11:00 Global Trials: Experience in Cardiovascular Medicine Elliott M. Antman
12:00 Industry Perspective & Discussion Thomas P. Haverty

  12:30 - 1:30 Lunch

 

Thursday Afternoon, May 28

SESSION III - ETHICAL & REGULATORY ISSUES

Session Chair: Michael J. Brown
1:30 Ethical Issues in International Clinical Trials Bernard Lo
2:00 Multi-Regional Trials: Why be Concerned? A Regulatory Perspective on the Issues Robert T. O’Neill
2:30 An Overview of Issues Surrounding Multi-Regional Clinical Trials Bruce Binkowitz
3:00 Discussion Michael J. Brown

3:30 - 3:45   Break 

SESSION IV - GLOBAL SAFETY & PHARMACOVIGILANCE

Session Chair: Joanna F. Haas
3:45 Evaluating Drug Safety in Clinical Trials (and Observational Registries) Stuart J. Pocock
4:15 Global Drug Safety Surveillance Alexander M. Walker
4:45 Discussion Joanna F. Haas

5:30    RECEPTION IN SEBASTIAN’S CAFE

 

Friday, May 29

   8:00 a.m. - Continental Breakfast 

SESSION V - DESIGN AND ANALYSIS OF GLOBAL TRIALS

Session Chair: Stephen Lagakos
8:30 Estimation and Extrapolation of Optimal Treatment and Testing Strategies James Robins
9:15 Population Enrichment Designs: Case Study of a large Multi-National Cardiovascular Trial Cyrus R. Mehta
10:00 Discussion Stephen Lagakos
10:30 - 11:00   Break  

 

Directly following the workshop participants are invited to attend the 2009 Marvin Zelen Leadership Award Lecture by Dr. David DeMets on Challenges in Clinical Trials: Some Old and Some New.

 

 MARVIN ZELEN LEADERSHIP AWARD LECTURE

Chair: Cyrus R. Mehta
 
 11:00 Challenges in Clinical Trials: Some Old and Some New
David DeMets

 

A luncheon reception will follow at noon at Sebastian's Cafe