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.
Scientists and medical researchers conduct clinical trials to test whether a new product works as expected and is effective at treating disease. Clinical trials with patients suffering from a specific condition represent the crucial link between scientific discovery and medical utility. However, many barriers impede the effectiveness of clinical research in the United States. Planning and executing a clinical trial can take years and cost hundreds of millions of dollars. Our nation’s clinical trial infrastructure is not well developed; clinical trials must be conducted in a “one-off” manner, in which substantial resources—such as funding, investigators, administrators, and patients—are used for only a finite period of time and then disbanded. Also, clinical trial sponsors, investigators, and research institutions face significant regulatory and administrative hurdles. Finally, patients and providers often do not participate in clinical research in sufficient numbers to support the science, and this problem is compounded by the general lack of public understanding of the value of clinical research and its direct link to improvements in health care.
The IOM held a public workshop October 7-8, 2009, to evaluate the state of clinical research in the U.S. and to identify strategies for improving clinical trials’ efficiency and effectiveness. Clinical trial experts discussed their successes, failures, and challenges in conducting clinical research. This document summarizes the workshop.
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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