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Federal program provides a national approach to therapeutics education and research through a public-private partnership

Advances in medical therapeutics have improved longevity and quality of life. However, inadequate and/or inappropriate use of drugs, biologic products, and medical devices is a significant problem. The Centers for Education and Research on Therapeutics (CERTs) provide a mechanism for coordinated systematic study of the critical issues in therapeutics and a means to educate providers and the public about them. The seven CERTs, a public-private partnership that involves academic medical centers, the Federal government, medical products industry, and the public, are administered and supported by the Agency for Healthcare Research and Quality (HS10548) in conjunction with the U.S. Food and Drug Administration.

The goal is to develop effective strategies to optimize the benefits and manage the inherent risk in therapeutic medical products. For example, often new drugs and medical devices are evaluated in short-term studies that will permit rapid regulatory evaluation and approval. However, some drugs and devices approved from such trials have subsequently presented serious problems. Also, the vast majority of adverse outcomes are not reported, leading to years of continued patient treatment even while the agents are known to cause specific problems, notes Robert M. Califf, M.D., of the CERTs Coordinating Center.

The goal of the CERTs is to increase knowledge before and after marketing of drugs and medical devices begins and to develop a national database of this information. Over 100 CERTs projects are in progress or have been completed. One example is the work of several centers aimed at reducing inappropriate prescribing of QT-prolonging drugs. The Georgetown CERTs maintains a prospective registry of patients who develop the potentially lethal event of torsades de pointes from QT-prolonging drugs, while the Duke CERTs has been evaluating the launch of the drug dofetilide, an agent found to cause QT prolongation and torsades de pointes in the registration trials prior to marketing. Also, the Vanderbilt CERTs is doing fundamental work examining the biology of sodium and potassium channels, which are the basis for QT prolongation.

See "The need for a national infrastructure to improve the rational use of therapeutics," by Dr. Califf, in Pharmacoepidemiology and Drug Safety 11, pp. 319-327, 2002.

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