Doris Duke Charitable Foundation

Clinical Research Systems

Rationale

Clinical research requires not only human and research capital, facilities, and equipment, but it also requires robust support systems, including appropriate regulatory organizations and processes, common language, analytical tools, databases and information systems, as well as mechanisms to distribute findings and interface with the public.

There is little doubt that the increasing complexity and growth of today’s clinical research enterprise has strained the existing support systems. It is these systems that the Medical Research Program is interested in supporting through activities that seek to identify ways to strengthen the regulatory processes and systems for clinical research, such as the protection of human subjects.

Grant Details

The foundation does not expect to award any major grants in this area in 2007, but is willing to consider exceptional opportunities that may arise. To date, the foundation has supported the following project in this area:

Consortium to Examine Clinical Research Ethics

With experts from academia and industry, the consortium is the first major non-government financed effort to collect primary data and critically examine human subject protection. The foundation has supported the consortium from 2000 through 2005 with three grants totaling $930,000. Consortium members include:

• Angela J. Bowen, MD, Western Institutional Review Board
• David M. Cocchetto, PhD, GlaxoSmithKline
• Ezekiel J. Emanuel, MD, PhD, National Institutes of Health
• Ruth R. Faden, PhD, MPH, Johns Hopkins University
• Alan R. Fleischman, MD, New York Academy of Medicine
• Kenneth A. Getz, MBA, CenterWatch
• Dale Hammerschmidt, MD, University of Minnesota
• Carol Levine, MA, United Hospital Fund
• Jeremy Sugarman, MD, MPH, MA,
  Johns Hopkins University