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Annual Report

Year 7

October 2005-September 2006


Summarizes the work of the Centers for Education & Research in Therapeutics (CERTs) for October 2005 through September 2006. CERTs is a network of research centers funded by the Agency for Healthcare Research and Quality (AHRQ) in consultation with Food and Drug Administration that conducts research and provides education to advance the optimal use of drugs, medical devices, and biological products.

This report was supported by grant HS13474 from AHRQ for the Centers for Education & Research on Therapeutics (CERTs).

Vision

To serve as a trusted national resource for people seeking to improve health through the best use of medical therapies.

Mission

To conduct research and provide education that will advance the optimal use of drugs, medical devices, and biological products.

Values

Public Interest. Research must be conducted to answer important questions that otherwise may not be addressed, with higher priority given to projects that offer better opportunities to achieve our mission and vision.

Public-Private Partnership. Collaboration of groups with different perspectives and resources—patients, health care providers, government, academia, delivery systems, payers, purchasers, and manufacturers of medical products—is a cost effective way to achieve results of mutual benefit and with greater responsiveness to the needs and interests of more sectors in society.

Multidisciplinary Alliances. The best research harnesses the collective expertise of medical practitioners, biostatisticians, clinical pharmacologists, health services researchers, clinical epidemiologists, pharmacists, clinical researchers, and others involved in health care.

Communication. The information from the CERTs must be made readily available to all relevant audiences.

Education. Education of current and future health care providers, policymakers, and patients is critical to improving health.

Public Policy. Policymakers must be provided with the best available evidence upon which to base policies.

Accountability. Americans should expect the CERTs to be a trusted resource of scientific evidence regarding therapeutics when they need answers to questions about therapies.

Contents

Letter from the Agency for Healthcare Research and Quality
Letter from the Steering Committee
Introduction
CERTs Progress
CERTs Research Centers Added in 2006
CERTs Program Resources
CERTs Partnerships and Collaborations
    Partnerships to Advance THerapeutics (PATHs)
    Partnership and CERTs Medical Devices Workshop
Conclusion
The CERTs Organization
Principles of CERTs Public-Private Partnerships
CERTs Project Partners
Peer-Reviewed Publications: October 1, 2005-September 30, 2006
    Referenced Publications
    Additional Publications

Introduction

The Centers for Education & Research on Therapeutics (CERTs) program serves the American people by providing valuable information to health care providers, patients, and policymakers about the safety and effectiveness of therapeutics—drugs, medical devices, and biological products such as vaccines. The CERTs conduct state-of-the-art research about the safe use, risks and benefits, and cost-effectiveness of therapeutics.

The CERTs program currently consists of a network of 11 research centers, public and private partners, a coordinating center, and a national steering committee — all dedicated to making improvements to the quality and safety of therapeutics. This year four new research centers joined the CERTs program to build on and enhance the work of the existing centers.

Since the inception of the CERTs program in 1999, the centers have developed a portfolio of nearly 400 projects. Subjects range from therapies for mental health to therapies for older adults and the effects of aging. As we complete our seventh year of work, we remain involved in research related to some of the most challenging medical issues of the day. In addition to research, the centers take a leading role in providing objective information to educate patients, doctors, pharmacists, health plan providers, and others about the drugs, devices, and biological products that play such an important role in our daily lives.

This report highlights the various CERTs research and educational projects completed over the past year, as well as several projects in progress.

The CERTs program is funded and managed 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.

Examples of Medical Therapies

Therapy Examples
Drugs: Prescription medications; over-the-counter medicines
Medical devices: Coronary stents; blood glucose monitors
Biological products: Vaccines; blood products

Centers and Their Emphases

Arizona CERT at The Critical Path Institute (C-Path): Detection and prevention of adverse drug interactions.

Duke University Medical Center: Therapies for disorders of the heart and blood vessels.

HMO Research Network: Use, safety, and effectiveness studies of therapeutics, using health plans for defined populations.

* Rutgers, The State University of New Jersey: Therapies for mental health.

University of Alabama at Birmingham: Therapies for musculoskeletal disorders.

* University of Iowa: Therapies for older adults and the effects of aging.

University of North Carolina at Chapel Hill: Therapies for children.

University of Pennsylvania School of Medicine: Therapies for infection; reduction in antibiotic resistance.

* University of Texas MD Anderson Cancer Center and Baylor College of Medicine: Risk and health communication; patient, consumer, and professional education; health decisionmaking and decision support; therapeutic adherence.

Vanderbilt University Medical Center: Prescription drug use in Medicaid and veteran populations.

* Weill Medical College of Cornell University: Therapeutic medical devices.

*New center as of April 2006.

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