Clinical Trial Registries:
Challenges and Opportunities
PAS/PPC State of the Art Plenary

Chair: Myron Genel, Chair, Public Policy Council and Professor Emeritus of Pediatrics, Yale University School of Medicine, New Haven, CT

Over the past year there has been a great deal of attention in the medical literature and lay press to the availability of data conducted by pharmaceutical firms, particularly when that data reveals potential side effects or fails to demonstrate significant benefit. The American Medical Association’s Council on Scientific Affairs has recommended that the Department of Health and Human Services establish a comprehensive registry for all clinical trials and that results from these trials be publicly available. The Council as well as the International Committee of Medical Journal Editors (ICMJE) has also recommended that institutional review boards require registration of clinical trials and the ICMJE will soon require registration as a precondition for publication. Finally legislation has been introduced—The Fair Access to Clinical Trials (FACT) Act—that would codify these recommendations for all clinical trials irrespective of sponsorship, perhaps through expansion on the National Library of Medicine’s ClinicalTrials.gov website. This symposium, the 12th Annual Public Policy Plenary organized by the Public Policy Council and the Public Policy and Advocacy Committee of the Ambulatory Pediatric Association, will explore the implications of these proposals, particularly for pediatric investigation and clinical practice, with a panel of international authorities. Time has been set aside to allow meaningful discussion involving the panel and audience.

Target Audience: Pediatric clinicians and clinical investigators.

4:15

Overview
Myron Genel, Chair, Public Policy Council and Professor Emeritus of Pediatrics, Yale University School of Medicine, New Haven, CT

4:20

Why We Need a Global, Unified System for Clinical Trial Registration
Kay Dickersin, Director, U.S. Cochrane Center and Professor Community Health, Brown University, Providence, RI

4:40

Registering Clinical Trials—The Response from Medical Journals
Christine Laine, Deputy Editor, Annals of Internal Medicine and Executive Secretary, International Committee of Medical Journal Editors, Philadelphia, PA

5:00

ClinicalTrials.gov–For All and Open To All
Donald Lindberg, Director, National Library of Medicine, NIH, Bethesda, MD

5:20

Implications for Pediatric Research
David J. Schonfeld, Chair, American Academy of Pediatrics Committee on Research, Yale University School of Medicine, New Haven, CT

5:40

Discussion. Panel & Audience

Sponsored jointly by the Public Policy Council, the Public Policy Advocacy Committee of the Ambulatory Pediatric Association and the Pediatric Academic Societies