Meeting

Transforming Clinical Research In The U.S.

When:: Wednesday, October 07, 2009 - Thursday, October 08, 2009 (12:00 AM)
Where:: Keck Center (100) • 500 Fifth St. NW, Washington, DC 20001 Map

Topic(s):: Biomedical and Health Research, Public Health
Activity:: Forum on Drug Discovery, Development, and Translation
Board(s):: Board on Health Sciences Policy

Is the current system for conducting clinical research in the US meeting the needs of the nation? There are growing indications that it is not. Phase III clinical trials have become extraordinarily expensive—it now costs more than $800 million to produce a new drug in the US. Patient enrollment and physician participation in clinical trials are inadequate to sustain a vigorous drug development pipeline, and clinical research is shifting overseas at an alarming rate. To address these concerns, the Institute of Medicine (IOM) Forum on Drug Discovery, Development, and Translation is convening the first in a series of public workshops that will examine the state of clinical trials in the US. The objectives are to identify areas of strength and weakness in our current clinical trial enterprise, and consider transformative strategies for enhancing the ways in which clinical research is organized and conducted.

Through a series of case studies and expert perspectives, participants will examine clinical research networks and large, phase III trials in different disease areas—cardiovascular diseases, depression, cancer, and diabetes. The goal is to understand the approaches that these networks have utilized in addressing the special issues and problems they face, successfully or not, and thereby derive lessons that can be applied in other areas. Presentations and public discussion will address a broad range of factors in extracting answers to these questions:

Strategies for organizing clinical research networks--academic-industry relationships; centralized versus decentralized models; network size and scope; established versus single-purpose networks;
The differences between investigator-initiated, industry-driven, and patient group sponsored research efforts;
The infrastructure in place to support researchers--e.g., information technology; training; enrollment; patient management systems; overall funding per patient
Management of the network--e.g., standardization and quality control; incentives; use of performance metrics; informed consent issues; payment issues.

Chaired by Jeffrey Drazen, Editor-in-Chief of the New England Journal of Medicine, a group of eminent research leaders from industry, academia, government, and patient groups will probe these questions, and through expert presentations and public discussion, examine strategies for enhancing clinical trials--from practical, incremental improvements to broad, transformative change.

Confirmed speakers include:

Barbara Alving

National Center for Research Resources, NIH

Robert Califf, Moderator

Duke University Medical Center

Renzo Canetta

Bristol-Myers Squibb

Judith Fradkin

National Institute of Diabetes and Digestive and Kidney Diseases, NIH

Carla Greenbaum

Benaroya Research Institute

Paul Hebert