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1 Introduction
Pages 1-4

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From page 1...
... What the concepts of "evidence-based medicine" and "learning health care system" have in common is their reliance on the accumula tion of medical knowledge based on science, not hope, and, further, that clinicians would take that knowledge out of the medical textbooks and laboratory notebooks and apply it in the care of individual patients and patient populations. Clinical trials are the linking step that enables basic research findings to emerge at the patient's bedside and in physicians' examining rooms.
From page 2...
... In short, as discussed at a 2009 workshop of the IOM's Forum in Drug Discovery, Development, and Translation, there is concern that "the current clinical trials enterprise in the United States is unable to produce the high-quality, timely, and actionable evidence needed to support a learning health care system" (IOM, 2010a)
From page 3...
... The workshop covered the topics of recruiting and retaining people to serve as trial participants, increasing practicing clinicians' participation in and referrals to trials, and strengthening the public opinion climate in which clinical trials are carried out and, ultimately, brought into routine medical practice. Workshop co-host Dennis Charney, Dean, Mount Sinai School of Medicine, set the tone for the meeting at its outset by saying that the ulti mate success of his school and its new strategic plan will be based not on "how many papers we publish, or grants we get." Success, he said, will depend on the answer to the question, "Did we contribute to changing the practice of medicine for the better?
From page 4...
... 4 PUBLIC ENGAGEMENT AND CLINICAL TRIALS commented that when patients say to him, "I don't want to be a guinea pig," he responds, "If I treat you based on what we know about your situ ation, you are a guinea pig anyway, because I don't know what works. At least this way, your therapy will teach us something." And, he adds, many other people may benefit from that knowledge in the future.


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