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AHCPR launches research program to improve the safe and effective use of medical products

The Agency for Health Care Policy and Research recently 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 (CERTs). AHCPR has awarded $7.7 million over a 3-year period in cooperative agreements to the Duke University Medical Center in Durham, NC, the University of North Carolina, Chapel Hill, Vanderbilt University, Nashville, TN, and Georgetown University Medical Center in Washington, DC, to operate the centers. Duke University also will 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 CERTs demonstration program is intended 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 the Food and Drug Administration.

The CERTs 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. Potential study topics include therapeutic drug monitoring in HIV-infected children, drug metabolism, vitamin D-deficient rickets, asthma care, attention deficit/hyperactivity disorder, and adverse drug reactions.

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 use of prescription medicines 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 aimed at physicians, pharmacists, and patients on specific drug interactions.

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