RFA-HS-10-008: AHRQ Developing Prospective Practice-based Comparative Effectiveness Research Clinical Registries: Orthopedic Devices, Drugs, and Proce

AHRQ Issues Funding Opportunity Announcements (P 50)

Dear Colleague:

We are pleased to inform you about a funding opportunity announcement (FOA) issued on July 6 by the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality (AHRQ).

Through RFA-HS-10-008, “AHRQ Developing Prospective Practice-Based Comparative Effectiveness Research Clinical Registries: Orthopedic Devices, Drugs, and Procedures (P50),” will support the development of a sustainable, prospective clinical registry of orthopedic devices, drugs, and procedures. Letters of intent are due by September 4, 2009, and the application receipt date is September 23, 2009.

The goal of developing this practice-based data registry is to conduct rigorous clinical and scientific research, including comparative effectiveness and safety research. The registry will provide evidence regarding the short- and long-term benefits and harms of implantable orthopedic devices, drugs, and other procedures. AHRQ anticipates that this type of research data infrastructure will become a model and basis for developing similar national registries.

The registry effort’s initial focus will be to develop an infrastructure for data collection and comparative effectiveness research activities with a concentration on hip and knee replacements. The applicant is expected to form the core of the registry: a Research and Data Coordinating Center functioning through the guidance of the Registry Steering Committee. The applicant is also expected to develop a registry infrastructure that includes at least five clinical centers at institutions that perform high volumes of hip and knee replacements.

The registry will also provide the infrastructure to conduct multicenter collaborative clinical studies to address effectiveness and patient outcomes questions as well as emerging public health issues related to orthopedic procedures and devices. A minimum of three core research studies are to be included in the grant application for the orthopedic registry under the P50 specialized center grant mechanism.

Thank you,
Effective Health Care Program
effectivehealthcare.ahrq.gov


Part I Overview Information
--------------------------
Department of Health and Human Services

Participating Organizations
Agency for Healthcare Research and Quality (AHRQ), (http://www.ahrq.gov)

Components of Participating Organizations
Center for Outcomes and Evidence (COE) (http://www.ahrq.gov)

Title: AHRQ Developing Prospective Practice-based Comparative Effectiveness Research Clinical Registries: Orthopedic Devices, Drugs, and Procedures (P50)
Note: The policies, guidelines terms and conditions stated in this announcement may differ from those used by the NIH.

Announcement Type
This Funding Opportunity Announcement (FOA) is a new RFA

Request For Applications (RFA) Number: RFA-HS-10-008

Catalog of Federal Domestic Assistance Number(s)
93.226

Key Dates
Release Date: July 6, 2009
Letters of Intent Receipt Date(s): September 4, 2009
Application Receipt Dates(s): September 23, 2009
Peer Review Date(s): Generally four months after receipt date
Earliest Anticipated Start Date: Generally four months after peer review date
Additional Information To Be Available Date: Not applicable
Expiration Date: September 24, 2009

Due Dates for E.O. 12372
Not Applicable

Additional Overview Content
Executive Summary
Purpose

AHRQ invites applications to develop a prospective clinical registry of orthopedic devices, drugs, and procedures through a practice-based research collaborative and clinical and outcomes data resource (P50 grant mechanism). The goal of this registry initiative is to support the development of a sustainable data infrastructure and to conduct rigorous clinical and scientific research including comparative effectiveness and safety research. AHRQ envisions utilizing a practice based orthopedic registry across a broad provider network as one of the potentially most effective and productive approaches to develop scientific evidence regarding the short and long term benefits and harms of implantable orthopedic devices and other related services. The registry will be a model and basis for other national device and procedure registries and will actively disseminate study results into clinical practice.

The Medicare Prescription Drug, Improvement, and Modernization Act (MMA) Section 1013 (42 USC 299b-7)(see http://effectivehealthcare.ahrq.gov/) authorized AHRQ to develop a program of comparative effectiveness research, thus, establishing the Effective Health Care (EHC) Program. To help achieve the objectives of the EHC program, AHRQ will provide support to develop and maintain the infrastructure of a multi-center orthopedic registry and the conduct of multiple collaborative, prospective multi-center studies of orthopedic devices and procedures. The capacity to include community-based smaller practice sites, in addition to high volume institutions, as participants in the registry is strongly encouraged.

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RFA-HS-10-008: AHRQ Developing Prospective Practice-based Comparative Effectiveness Research Clinical Registries: Orthopedic Devices, Drugs, and Procedures (P50)