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 7 Reports
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Addressing the Threat of Drug-Resistant Tuberculosis: A Realistic Assessment of the Challenge. Workshop Summary
Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs--a major and growing threat worldwide. The Institute of Medicine’s Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.
Released: August 26, 2009
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Accelerating the Development of Biomarkers for Drug Safety. Workshop Summary
Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. On October 24, 2008, the IOM’s Forum on Drug Discovery, Development, and Translation held “Assessing and Accelerating Development of Biomarkers for Drug Safety,” a one-day workshop on the value of biomarkers in helping to determine drug safety during development.
Released: June 19, 2009
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Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies. Workshop Summary
The process for developing new drug and biologic products is extraordinarily expensive and time-consuming—many consider the traditional model to be unsustainable. Although large pharmaceutical companies may be able to invest in the development of blockbuster drugs because they can expect a large return on their investment, these same organizations, when developing drugs to treat rare and neglected diseases, are unable to rely on such returns. On June 23, 2008, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation held a public workshop, “Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies,” which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.
Released: February 19, 2009
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