Research to inform policy on the development of a national rapid learning system for new biomedical technologies, products and treatments
The purpose of this project is to consider national strategies for learning as rapidly as possible about the best use of new biomedical technologies, products, and treatments. The evolution of electronic health records, the internet, and computing capacity make it technically feasible to devise a national system of real-time reporting of clinical experience for millions of patients to national databases for collaborative research. Such information could be analyzed for: (1) better informing clinicians and patients about the benefits and risks of different therapy choices; (2) accelerating and improving the process of guidelines development and quality measures; (3) providing valuable feedback to the National Institutes of Health, university researchers, and pharmaceutical and biotechnology companies about how new products and technologies are working; (4) providing more timely and accurate information for FDA to monitor patient safety and effectiveness; (5) providing information on "off-label" uses for clues about potential new benefits of existing technologies; and (6) providing major payers, such as Medicare, Medicaid, and health plans, with much better evidence for coverage decisions and evolution of payment systems based on evidence-based protocols. The development of such rich databases could be particularly important for advancing clinical knowledge and practice for population groups that are frequently under-represented in clinical trials, such as racial and ethnic minorities, women, children, seniors, and persons with multiple chronic conditions. The U.S. system of technology evaluation needs to be reconsidered in light of such new needs and possibilities. This project will explore different technology assessment systems and how they are organized. A series of small meetings will bring together experts to consider: (1) the needs and opportunities for a national rapid learning system; (2) the key system design issues and options; and (3) financing, administration, and next steps toward development of such a system. These meetings will be done in collaboration with Health Affairs and result in a paper that will present the key findings and understandings. A second paper will be produced to look at a Medicare-funded system for technology assessment for seniors and disabled persons.
Amount Awarded $202,310.00
Awarded on: 7/25/2005
Time frame: 8/1/2005 - 1/31/2007
Grant Number: 53797