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AHCPR Launches Research Program to Improve the Safe and Effective Use of Medical Products

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Press Release Date: September 29, 1999

The Agency for Health Care Policy and Research (AHCPR) today launched a new research program to boost the positive impact on patient care of medical products—drugs, biologics and medical devices—by establishing four Centers for Education and Research on Therapeutics (CERT).

Deputy Administrator Lisa M. Simpson, M.B., B. Ch., announced that AHCPR has awarded $7.7 million over a three-year period in cooperative agreements to the Duke University Medical Center in Durham, N.C., the University of North Carolina in Chapel Hill, N.C., Vanderbilt University in Nashville, Tenn., and Georgetown University Medical Center in Washington, D.C., to operate the centers. Duke University will also include a coordinating center for the program. The centers will conduct pilot studies using state-of-the-art clinical, laboratory and health services research methodologies.

The CERT demonstration program was authorized by Section 409 of the Food and Drug Administration (FDA) Modernization Act of 1997 (Public Law 105-115) to improve the quality of health care and reduce costs by increasing awareness of the benefits and risks of new uses or combinations of medical products, and by improving the effectiveness of existing uses. AHCPR administers the program in consultation with FDA.

"Effective and safe medical products have greatly enhanced the quality of health care in this country. However, research continues to show instances of underuse, overuse and misuse of these products. The CERT program will help by giving doctors, pharmacists and patients the scientific information they need to use products better and more safely," said Dr. Simpson.

FDA Commissioner Jane E. Henney, M.D., said, "This program will improve our understanding of both the risks involved in using medical products, and the sources of those risks, which is one of the goals identified in the recent report of FDA's special task force on risk management."

The CERT centers and their principal investigators are:

  • Duke University Clinical Research Institute Cardiovascular CERT. Principal investigator: Robert M. Califf, M.D. Total projected funding: $2,802,813. Funding period: 9/30/99-9/29/02.

    This center will focus on currently approved therapies in cardiovascular medicine, including special surveillance programs for cardiovascular devices, revascularization, new prosthetic valves and coronary stents. In addition, the center will conduct demonstration projects involving the treatment of congestive heart failure, chest pain and abnormal heart rhythms.

  • University of North Carolina CERT on Rational Therapeutics for the Pediatric Population. Principal investigator: William Campbell, Ph.D. Total projected funding: $1,984,255. Funding period: 9/30/99-9/29/02.

    Improvement in child health is the focus of this center. Activities may include innovative education and research on new drugs and devices used in pediatric care and new uses of existing drugs and devices. Studies including therapeutic drug monitoring in HIV-infected children, drug metabolism, vitamin D-deficient rickets, asthma care, attention deficit/hyperactivity disorder and adverse drug reactions may be undertaken.

  • Vanderbilt University CERT. Principal Investigator: Wayne Ray, Ph.D. Total projected funding: $1,353,507. Funding period: 9/30/99-9/29/02.

    The goal of this center is to improve prescription medication use in Medicaid managed care by combating three specific threats to rational pharmacotherapy: inadequate knowledge of medications and their benefits and risks, inadequate provider and patient behavior, and policies that lead to poor patient outcomes. A major focus of this project will be the treatment of arthritis.

  • Georgetown University Medical Center CERT. Principal investigator: Raymond L. Woosley, M.D., Ph.D. Total projected funding: $1,549,628. Funding period: 9/30/99-9/29/02.

    The center will focus on reducing drug interactions, particularly in women, by improving prescribing. Objectives include identifying potential candidates for investigations of drug interactions, and designing and implementing a comprehensive educational program on specific drug interactions aimed at physicians, pharmacists and patients.

AHCPR is the lead agency within HHS for supporting research designed to improve the quality of health care, reduce its cost and broaden access to essential health services. AHCPR sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use and access. AHCPR's pharmaceutical outcomes research program, initiated in 1992, helped identify key issues and formed the basis of the CERT program.

For additional information, please contact AHCPR Public Affairs, (301) 427-1364: Karen Migdail (301) 427-1855 (

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