CHAIR
:
Kenneth I. Kaitin, PhD, Director, Tufts Center for the Study of Drug Development, Tufts University
SPEAKER
(S):
John Alam, MD, Executive Vice President, Medicines Development and Chief Medical Officer, Vertex Pharmaceutical
Ronnie Todaro, MPH, Director of National Programs, Parkinson's Disease Foundation (PDF)
R. Alta Charo, JD, Warren P. Knowles Professor of Law & Bioethics, University of Wisconsin Law School
Deborah A. Zarin, MD, Assistant Director for Clinical Research Projects Director, ClinicalTrials.gov, Lister Hill National Center for Biomedical Communications,National Library of Medicine
Description
There has been a well-publicized demand for broader public access to information about ongoing, completed and published clinical trials to help physicians and patients make treatment decisions. Stakeholders are working to evolve a process of publication of trial results that will satisfy diverse stakeholders while 1) protecting the public from reliance on misleading information and 2) protecting industry from claims of off-label promotion.
Objectives:
Identify where industry was in June 2004 and where we are today in terms of publicly disclosing information about clinical trial results.
Explore challenges of disseminating trial results in a manner that will be meaningful to the patient and health-care provider.
Explore how industry will be affected by proposed changes in requirements.