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A better way to test new treatments? Approach could help patients and give useful results
Date:7/2/2012

e University of Virginia, Medical College of Georgia, University of Texas Southwestern, and the NETT Statistical and Data Management Center at the Medical University of South Carolina.

Other emergency treatment studies now being planned at U-M with collaborators from throughout the country with adaptive design include one for therapeutic hypothermia after cardiac arrest, and hypothermia after spinal cord trauma. In both cases, it's not yet known what length of time for cooling produces the best outcome for patients, though cooling is being used for both types of patients already. In addition, the team has also developed an adaptive comparative effectiveness trial to evaluate three different medications to stop ongoing seizures in patients who have failed first line treatment.

When time is of the essence and patients or their loved ones are being asked to make a decision about being in a clinical trial at the very time when they are in a health crisis, and the difference between treatment options could be large, adaptive design can be most powerful, Meurer says. Pharmaceutical companies and medical device manufacturers have been faster to adopt adaptive design for their trials, but academic centers that conduct huge numbers of non-industry trials have not.

But when researchers just want to compare two standard treatments to make sure one isn't grossly inferior, or when they want to pinpoint the precise impact of a preventive measure (such as aspirin) across a large population (such as heart attack survivors), adaptive designs usually won't help, he notes.

"Adaptive design gives us the potential to get it right and put more people where the bang for the buck is, but still have the change be invisible to the physicians and staff carrying out the trial," Meurer says. "If a particular option helps patients about 10 percent more than other options, but the adaptive design's impact on the statistical results means that you can only sa
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Contact: Kara Gavin
kegavin@umich.edu
734-764-2220
University of Michigan Health System
Source:Eurekalert

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