Report
Note: Workshop Summaries contain the opinion of the presenters, but do NOT reflect the conclusions of the IOM. Learn more about the differences between Workshop Summaries and Consensus Reports.
All pharmaceutical products have inherent risks, and their use involves trade-offs between these risks and their therapeutic benefits. However, the public has a limited understanding of this trade-off, and many individuals believe that drugs approved by the Food and Drug Administration carry no risks. Assessing, managing, and communicating the benefit-risk profile of a pharmaceutical product is a complex and nuanced scientific, political, and sociological challenge. To explore these issues, the Forum on Drug Discovery, Development, and Translation conducted a public workshop, entitled Understanding the Benefits and Risks of Pharmaceuticals. Its broad goals were to gain a better understanding of the current system used to evaluate benefit and risk and to identify opportunities for improvement.
Discussions during the workshop focused on
- premarket assessment, during which clinical trial data are used to assess benefit and risk;
- communication of that information to prescribing physicians and their patients;
- healthcare decisions made by prescribing physicians and their patients; and,
- the accumulation and assessment of benefit-risk information gained from postmarketing experience.
Other Reports by this Activity
Displaying: 3 of 14 Reports
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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development - Workshop Summary
The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Released: December 21, 2011
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Public Engagement and Clinical Trials: New Models and Disruptive Technologies - Workshop Summary
Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.
Released: October 14, 2011
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Advancing Regulatory Science for Medical Countermeasure Development - Workshop Summary
Whether or not the United States has safe and effective medical countermeasures—such as vaccines, drugs, and diagnostic tools—available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the IOM held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures.
Released: June 15, 2011
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