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CERTs Overview

Fact Sheet


The Centers for Education and Research on Therapeutics (CERTs) program is a national initiative to increase awareness of the benefits and risks of new, existing, or combined uses of therapeutics through education and research. This Overview summarizes the CERTs program.

Purpose / Background / CERTs Implementation / Partnerships and Collaboration / CERTs Coordination / More Information


Purpose

The Centers for Education and Research on Therapeutics (CERTs) demonstration program is a national initiative to conduct research and provide education that advances the optimal use of therapeutics (i.e., drugs, medical devices, and biological products). The program consists of 6 research centers and a CERTs Scientific Forum and is funded and run as a cooperative agreement by the Agency for Healthcare Research and Quality (AHRQ), in consultation with the U.S. Food and Drug Administration (FDA).

The CERTs receive funds from both public and private sources, with AHRQ providing core financial support. The research conducted by the CERTs program has three major aims:

  1. To increase awareness of both the uses and risks of new drugs and drug combinations, biological products, and devices, as well as of mechanisms to improve their safe and effective use.
  2. To provide clinical information to patients and consumers; health care providers; pharmacists, pharmacy benefit managers, and purchasers; health maintenance organizations (HMOs) and health care delivery systems; insurers; and government agencies.
  3. To improve quality while reducing cost of care by increasing the appropriate use of drugs, biological products, and devices and by preventing their adverse effects and consequences of these effects (such as unnecessary hospitalizations).

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Background

Since 1992, AHRQ has funded studies focused on patient outcomes associated with pharmaceutical therapy. Through this Pharmaceutical Outcomes Program, these studies have addressed many important questions regarding the management of drug prescribing.

The CERTs concept grew out of recognition that, while pharmaceuticals and other medical products improve the lives of many patients, underuse, overuse, adverse events, and medical errors may cause serious impairment to patient health. The following gaps in knowledge remain:

  • Limited comparative information exists on the risks, benefits, and interactions of both new and older agents.
  • Health professionals need guidance on the appropriate, cost-effective use of therapeutics that will, in turn, lead to improved outcomes, error reduction, and prevention of adverse events.

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CERTs Implementation

Because of AHRQ's demonstrated expertise in pharmaceutical outcomes research, it was given responsibility for administering the CERTs demonstration program authorized by Congress as part of the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115).

Each of the 6 CERTS research centers focuses on therapies used in a particular population or therapeutic area. These 6 research centers, a Scientific Forum, a Steering Committee, and numerous partnerships with public and private organizations now make up the CERTs program.

Center Emphasis
Brigham and Women's Hospital (U19 HS21094)
Principal investigator: David Bates, M.D., M.Sc.
Health information technology
Duke University Medical Center (U19 HS21092)
Principal investigator: Eric Peterson, M.D., M.P.H.
Therapies for heart and blood vessel disorders
Rutgers, The State University of New Jersey (U19 HS21112)
Principal investigator: Stephen Crystal, Ph.D.
Mental health therapeutics
University of Alabama at Birmingham (U19 HS21110)
Principal investigator: Kenneth G. Saag, M.D., M.Sc.
Musculoskeletal disorders
Cincinnati Children's Hospital Medical Center (U19 HS21114)
Principal investigator: Carole Lannon, M.D., M.P.H.
Pediatric therapeutics
Northwestern University (U19 HS21093)
Principal investigator: Bruce L. Lambert, Ph.D.
Tools for optimizing prescribing

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Partnerships and Collaboration

A core value of the CERTs program is the belief that collaboration among groups with different perspectives and resources is critical if the results are to be applicable in "real world" settings. The centers work with public and private collaborators on projects, which allows each center to expand the number of its projects and extend their potential impact.

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CERTs Coordination

The CERTs Scientific Forum is located at the Kaiser Foundation Center for Health Research. Directed by Stephen P. Fortmann, MD, the Scientific Forum helps support the work of the research centers by fostering collaborations, enhancing cross-center synergy, and disseminating findings from the research conducted by the centers.

A Steering Committee, organized by the Scientific Forum, serves in an advisory capacity to the CERTs program. Steering Committee members include representatives from each center, the Federal Government (AHRQ, FDA, and the National Institutes of Health), the private sector, and consumer groups. In addition, work groups of representatives from all centers address broad issues related to the CERTs effort, such as public-private partnerships.

AHRQ's Center for Outcomes and Evidence oversees the CERTs program and provides technical assistance and research support.

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More Information

More information on the CERTs program is available from:

Anne Trontell, M.D., M.P.H.
Program Director, Centers for Education and Research in Therapeutics
Center for Outcomes and Effectiveness, AHRQ
Phone: (301) 427-1607
Fax: (301) 427-1640
E-mail: Anne.Trontell@ahrq.hhs.gov

Kim Marie Wittenberg, M.A.
Center for Outcomes and Effectiveness, AHRQ
Phone: (301) 427-1488
E-mail: Kim.Wittenberg@ahrq.hhs.gov

In addition, the CERTs program welcomes input about the types of research and education needed to better address costs, effectiveness, and safety issues related to the use of therapeutics. Comments may be sent to CERTs program staff at AHRQ or to:

Meredith Vandermeer, MPH
CERTs Scientific Forum
Project Director
Phone: 503-335-6373
Fax: 503-335-2428
Email: Meredith.L.Vandermeer@kpchr.org

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AHRQ Publication No. 08-P009-EF
Current as of November 2013


Internet Citation:

Centers for Education and Research on Therapeutics (CERTs) Overview: Fact Sheet. AHRQ Publication No. 08-P009-EF. Agency for Healthcare Research and Quality, Rockville, MD. http://certs.hhs.gov/about/certsovr.htm


 

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