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December 20, 2011

Rochester researchers to give pain clinical trials a makeover

For chronic pain sufferers, a day can feel like a year and a year can feel like an eternity. With very few truly new therapies approved by the U.S. Food and Drug Administration for this condition since 2005, the outlook is far from bright.

The FDA has taken note. With up to $4.5 million in funding from the agency over the next five years, researchers at the Medical Center will study different approaches to improve the methods used to evaluate and approve new, safe, and effective treatments.

“Pain can cause considerable suffering, and it represents an enormous financial burden to society,” says Robert Dworkin, professor in the Department of Anesthesiology and the Center for Human Experimental Therapeutics at the Medical Center, who will spearhead the research. “Despite substantial attention in the pharmaceutical industry to developing novel pain therapies, the fact that so few improved treatments have become available is really surprising and is why the FDA is funding this initiative.”

According to Dworkin, one possible reason pain clinical trials are often unsuccessful is that patients in the placebo group, who get a dummy pill instead of the real treatment, frequently show greater-than-expected improvements. Consequently, it becomes difficult for researchers to show meaningful differences between the pain-lessening effects of the real drug and the dummy drug.

The FDA agrees that the problem may lie in the way new pain therapies are identified and studied.

“We’ve seen over the years that analgesic clinical trials frequently fail and often with drugs that we know work. When opioids that have been known to be effective for hundreds of years are put in clinical trials, we can’t get a positive result,” says Bob Rappaport, director of the Division of Anesthesia, Analgesia, and Addiction Drug Products 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 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, such as the experience and training of the lead investigator and staff.

To examine these questions, the team will scour FDA databases housing information from hundreds of pain clinical trials—an invaluable resource not typically available to researchers. They will also analyze previously published pain clinical trials and data from studies sponsored by various pharmaceutical companies.

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