Thursday Morning, May 28 |
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8:00 a.m. - Registration & Continental Breakfast
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SESSION I - OVERVIEW & KEYNOTE LECTURE |
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| 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 |
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10:00 - 10:15 Break |
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SESSION II - CASE STUDIES |
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| 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 |
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12:30 - 1:30 Lunch
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Thursday Afternoon, May 28 |
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SESSION III - ETHICAL & REGULATORY ISSUES |
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| 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 |
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3:30 - 3:45 Break |
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SESSION IV - GLOBAL SAFETY & PHARMACOVIGILANCE |
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| 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 |
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5:30 RECEPTION IN SEBASTIAN’S CAFE
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Friday, May 29 |
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8:00 a.m. - Continental Breakfast
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SESSION V - DESIGN AND ANALYSIS OF GLOBAL TRIALS |
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| 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 | ||
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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.
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MARVIN ZELEN LEADERSHIP AWARD LECTURE |
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| Chair: Cyrus R. Mehta |
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| 11:00 | Challenges in Clinical Trials: Some Old and Some New |
David DeMets |
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A luncheon reception will follow at noon at Sebastian's Cafe |
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