Programs
Risk Series
Program Overview
The Centers for Education and Research on Therapeutics (CERTs) is pleased to announce the Risk Series Program, an initiative developed to advance the nations' therapeutics. Over the past two years, in partnership with the U.S. Department of Health and Human Services (DHHS): Agency for Healthcare Research and Quality (AHRQ) and the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA); and the Pharmaceutical Research and Manufacturers of America (PhRMA), the CERTs program convened experts from government, the medical products industry, media, consumer groups, health care providers and researchers for a series of "Think Tanks" entitled the "Risk Series" to review how risk is assessed, communicated and managed. The workshops were facilitated by the nationwide CERTs Steering Committee along with leaders in the field of benefit and risk of therapeutics.
Since no medical product (drug, biologic, device) is absolutely safe, the U.S. system of developing and deploying medical therapies involves trade-offs—a certain amount of risk given a certain amount of benefit. Products approved for marketing thus reflect a balance between the known benefits and the known risks as used in a specific population at the time of approval. This leaves for the post-approval period, an important and complex challenge in the clarification of the actual effectiveness for general use and the emerging picture of risks.
Certain rare risks inherent in therapy are not known at the time of approval because of the small numbers involved in pre-approval trials. This can only be completely understood by a program of post-marketing surveillance, including spontaneous reaction reporting and epidemiological study. Further, when therapies are used inappropriately or their use is not monitored properly, the risk of adverse effects can increase or the hoped for off-setting benefits can be reduced. In more and more cases, failure to control such preventable risks, i.e., medical errors, has resulted in the removal of products from the market, thereby reducing treatment options for all of us. The CERTs program is working to reverse this trend.
The five workshops included Risk Communication; Risk Assessment; Benefit Assessment; Risk Communication and the Media; and Risk Management. Based upon an in-depth analysis of the current status of knowledge in the field, over 150 participants were asked to propose the top research questions and other unresolved issues as they pertained to each corresponding workshop topic. The Steering Committee subsequently discussed and ranked the findings from the workshops to craft a list of high priority contributions to the nation's evolving research agenda to improve the assessment, communication and management of therapeutic risk in the context of benefit.
The results of these workshops were discussed at the CERTs Risk Series Strategic Symposium: "Benefit the Patient, Manage the Risk", March 5-6, 2003. Discussion of the issues and questions raised at the symposium will provide a context for future research.