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AHCPR Seeks Ideas and Study Topics for New Research Demonstration Program on Therapeutics

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Press Release Date: November 3, 1998

The Agency for Health Care Policy and Research (AHCPR) today published a call for ideas and study topics for implementation of its new demonstration program for grants to establish Centers for Education and Research on Therapeutics (CERTs). The demonstration program, which was authorized by Section 409 of the Food and Drug Administration Modernization Act, is being developed in consultation with the Food and Drug Administration (FDA). AHCPR and FDA are agencies of the Public Health Service within the U.S. Department of Health and Human Services.

When established, the demonstration centers will conduct state-of-the-art clinical and laboratory research to increase awareness of new uses of drugs, biological products and devices; ways to improve the effective use of these; the risks of new uses and the risks of combinations of drugs and biological products.

The centers will also conduct research aimed at improving the quality of health care, while reducing costs, by increasing the appropriate use of drugs, biological products and devices, and by preventing potential adverse effects. Studies will, in addition, examine the comparative effectiveness and safety of drugs, biological products and devices.

Suggestions made in response to this notice will be considered for the development of a Request for Applications (RFA) for cooperative agreements to establish CERTs centers. The RFA will be published later this fiscal year (FY 1999, October 1, 1998-September 30, 1999). AHCPR will provide up to $2 million in FY 1999 to fund one or more centers.

John M. Eisenberg, M.D., AHCPR's administrator, said, "This program will help develop the evidence base for the appropriate and safe use of drugs, biological products and medical devices that clinicians, health system leaders and patients need for making the best possible decisions."

Because of the broad mission outlined in the legislation, AHCPR is requesting suggestions and comments on:

  • How the CERTs centers should be organized.
  • The appropriateness of AHCPR or these centers seeking additional funding partners to increase the resources available for research.
  • Initial areas of emphasis.
  • High-priority research topics.
  • Whether AHCPR should include a list of specific research topics in the RFA, to which applicants would respond, or whether the RFA should focus primarily on the infrastructure and capacity of applicants and identify specific research issues to be addressed following selection of the centers, as well as other issues that respondents believe need to be taken into account by the Agency.

Topics and ideas intended for consideration in FY 1999 must be submitted to AHCPR by December 18, 1998. Nominations after that date will be accepted on an ongoing basis for consideration in future studies.

Nominations should be submitted to the attention of Joanne Book at the Center for Outcomes and Effectiveness Research, Agency for Health Care Policy and Research, 6010 Executive Boulevard, Suite 300, Rockville, MD 20852. For further information, contact Lynn Bosco, M.D., M.P.H: (301) 427-1520; (LBosco@ahrq.gov). Select to access a copy of the Federal Register notice.

For additional information, please contact AHCPR Press Office: Karen Migdail, (301) 427-1855 (KMigdail@ahrq.gov).

The information on this page is archived and provided for reference purposes only.

 

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