Evidence-Based Health Care
A Macropolicy View of Comparative Effectiveness Research »
At an event hosted by the U.S. Chamber of Commerce’s National Chamber Foundation, Mark McClellan discussed comparative effectiveness as just one step in the process of developing and applying evidence to improve the quality and value of health care. |
The Engelberg Center is working to support the development of a national infrastructure for developing better evidence on health outcomes, beginning with a national strategy for monitoring medical product safety.
Informed clinical decisions at the bedside and across populations require evidence of the safety, effectiveness, and value of medical products (drugs, devices, and diagnostics). Recent product withdrawals and warnings have highlighted the limitations of both pre-launch data (collected through clinical trials) and spontaneous adverse event reports as ways of evaluating the risks, benefits, and value of medical products.
The FDA Amendments Act of 2007 mandated the development of a national, integrated, electronic safety system for monitoring medical product safety. The law sets a goal of access to data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. While broad-based support now exists for safety as an initial priority for post-market evidence, the infrastructure required to fulfill this mandate can be built to generate evidence on the effectiveness and value of medical products and strategies, as well.
Working closely with researchers, health care policy and evaluation experts, and the FDA, the Center has served as the neutral convener of three public workshops in 2008, each of which brought together a broad base of public- and private-sector stakeholders to discuss the objectives, implementation models, anticipated issues, and proposed solutions to developing a national medical product safety monitoring system (the Sentinel system). In addition, the Center has convened a series of seven Pilot Study Roundtables to review and discuss ongoing projects that could be informative to the development of Sentinel. The Roundtables are regularly attended by stakeholders in the federal government (FDA, AHRQ), academia, health plans, integrated delivery systems, non-profit foundations, and the biopharmaceutical industry. Building on these steps, the Engelberg Center will continue to support the implementation of a post-market evaluation system that is a source of credible evidence for patients, health care providers, and policy makers.
Better Results Through More Effective Use of Treatments
The recently enacted economic stimulus legislation created new funding and a Federal Coordinating Council for comparative effectiveness research (CER) on health care treatments and strategies. The Engelberg Center is collaborating with national experts and stakeholders to address challenges and next steps in implementing the policy, including analysis of existing CER efforts, as well as developing priorities and methods to ensure maximum impact of CER on health care quality, outcomes and value.
The Center’s work also informs the more effective use of an increasingly diverse and sophisticated range of medical treatments. These include, for example, how statistical methods and data from actual medical practice can be applied to learning more about the combination of treatments that work best for particular patients, and how policy reforms can promote more effective, personalized care. Through these collaborative efforts, the Center aims to provide insights into concrete strategies for achieving better results through more effective use of approved treatments.
Back to Engelberg Center Projects »