METHOD OF CONDUCTING A CLINICAL TRIAL
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United States of America Patent
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app pub date -
Jan 14, 2008
filing date -
Jan 19, 2007
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Abstract
Disclosed are methods of conducting and assessing the outcomes of a randomized controlled clinical trial. The method comprises the steps of: trialing, with respect to a first group of patients as an experimental group, an experimental treatment; and trialing, with respect to a second group of patients as a control group, at least first and second control therapies. The control therapies will have been previously validated or are a known standard of care. This method is described in relation to trialing and assessing implantable medical devices such as left ventricular assist devices (LVAD) but may be used for trialing and assessing other medical devices.
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