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FDA funds Rochester researchers to give chronic and acute pain clinical trials a makeover
Date:11/14/2011

s at the FDA's Center for Drug Evaluation and Research. "It has become clear to the entire pain community that there are design problems with the trials, making it difficult to accurately evaluate whether drugs work or not."

With the grant from the FDA, Dworkin, working closely with Dennis Turk, Ph.D., from the University of Washington in Seattle, will lead a team exploring how the design of chronic and acute pain trials might be improved. A multitude of factors may play a role, including: patient features, such as the patient's pain intensity and duration; the way studies are planned, like the length of a trial and frequency of patient visits; and study site characteristics, for example, the experience and training of the lead investigator and staff.

"We may see increasing improvement in the placebo group because the patients have a good relationship with the study nurse they see for each visit; she makes them feel supported and reassured, so they feel better and think their pain is getting better, even though they aren't getting the real treatment," said Dworkin. "It could just be positive, ongoing interactions with a really nice nurse that is leading to this effect we don't know."

Research shows that in psychiatry clinical trials, the more visits the greater the improvement in patients in the placebo group. "Among other research questions, we plan to study the number of visits built into pain clinical trials, testing weekly versus monthly patient visits. Perhaps we'll see a greater difference in pain reduction between patients taking the active drug and those getting placebo if there are fewer visits," he noted.

Other studies the team may pursue involve developing and testing the usefulness of methods to improve how accurately patients report their pain. If patients aren't good at describing their symptoms, this could influence the results of a trial. For example, it's possible that patients don't understand how importa
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Contact: Emily Boynton
emily_boynton@urmc.rochester.edu
585-273-1757
University of Rochester Medical Center
Source:Eurekalert

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