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U-M Receives NIH, FDA Grant To Study Adaptive Clinical Trial Design
Date:10/7/2010

usually only triggered when an overwhelming effect is seen.

Adaptive clinical trials can more seamlessly make use of accumulating information using Bayesian statistics – which allow data analysts to predict trial success based on early patient responses and other accumulating information.

"Adaptive design essentially allows the statisticians to continuously reanalyze the data over the entire study and we can end up changing how patients are assigned within the study if it really looks like it's working," says Barsan, who is also principal investigator of the clinical trials coordinating center of the Neurological Emergencies Treatment Trials Network. "We believe this is one way to avoid getting false negatives and it's better protection for patients which is really important."

The three-year project, "Accelerating Drug and Device Evaluation through Innovative Clinical Trial Design," is one of four recipients of a $9.4 million award by the National Institutes of Health-Food and Drug Administration Joint Leadership Council to spearhead collaborative activities to stimulate a new research in regulatory science.

The project is led by Barsan, Donald A. Berry, Ph.D., senior statistical scientist and founder of Berry Consultants, and Roger J. Lewis, M.D., Ph.D., co-chair of the Regulatory and Ethics Knowledge and Research Program and professor of emergency medicine at the University of California –Los Angeles.

The objective of the grant is to "optimize the design of four large, neurological emergency trials at various stages of development," Barsan says. "We'll use modeling and mathematical simulation to really kick the tires on a number of potential adaptive designs with the hope of gaining efficiency in the ultimate trial design. Hopefully it will lead to considerable savings in the research process and allow us to more accurately and rapidly identify treatments which improve patient outcomes."


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SOURCE University of Michigan Health System
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