Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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1 Introduction
1 Introduction
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There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure.
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Future Forum plans include the following: further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise. This report builds on a body of related IOM work.
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Once preliminary evidence from phase II reveals that a treatment is effective, phase III trials are designed to fully examine the risk/benefit profile of an experimental drug or treatment and test it over a longer period of time in a broader population (1,000−3,000)
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The workshop had three main objectives: • to examine the state of clinical research in the United States; • o identify areas of strength and weakness in the current clinical trial t enterprise by examining trials in the above four disease areas; and
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