Session Objectives:
  • Set out an organizational framework for an infrastructure to conduct clinical trials.
  • Discuss:

    organizational frameworks for the infrastructure (i.e., network models or other approaches);

    informatics needs;

    regulatory reform or harmonization both within the United States and internationally.

 Clyde Yancy, Session Chair
 Magerstadt Professor of Medicine
 Chief, Division of Cardiology
 Feinberg School of Medicine
 Northwestern University
10:55 a.m.Presentation of Discussion Paper: Developing a Clinical Trials Infrastructure
Petra Kaufmann
 Director, Office of Clinical Research
 National Institute of Neurological Disorders and Stroke
 National Institutes of Health
 Paul Eisenberg
 Senior Vice President
 Global Regulatory Affairs and Safety
 Amgen Inc.
 Janet Woodcock
 Director, Center for Drug Evaluation and Research
 U.S. Food and Drug Administration
11:45 a.m.Panel Discussion with Speakers: Establishing an Infrastructure to Support a Transformed Clinical Trials Enterprise
Objectives:
  • Consider the types of trials that should be done in the United States and what the site/locus for the conduct of these trials should be within the infrastructure model proposed.
  • What are the roles and responsibilities of the various participants and stakeholders in the proposed infrastructure of the clinical trials enterprise?
 Clyde Yancy, Panel Moderator
 Magerstadt Professor of Medicine
 Chief, Division of Cardiology
 Feinberg School of Medicine
 Northwestern University
 Louis Fiore
 Principal Investigator, VA Cooperative Studies Program
 Director, VA Cooperative Studies Program Coordinating Center, Boston
 Department of Veterans Affairs
 Michael King Jolly
 Senior Vice President
 Quintiles Innovation
 Karen Margolis
 Professor of Medicine, University of Minnesota Medical School
 Director of Clinical Research
 HealthPartners Research Foundation
12:30 p.m.LUNCH

From: Appendix A, Workshop Agenda

Cover of Envisioning a Transformed Clinical Trials Enterprise in the United States
Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing An Agenda for 2020: Workshop Summary.
Institute of Medicine (US).
Washington (DC): National Academies Press (US); 2012.
Copyright © 2012, National Academy of Sciences.

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