FDA Funds Evaluation of Pain Drug Clinical Trial Methods

(U.S. Food and Drug Administration)

The Food and Drug Administration is funding a study by researchers at University of Rochester in New York and University of Washington in Seattle to find different ways of evaluating drugs designed to relieve acute and chronic pain. The grant of up to $4.5 million over five years aims to better understand why few new drugs for pain have been able to succeed in clinical trials.

Robert Dworkin, professor of anesthesiology at Rochester and Dennis Turk, professor of anesthesiology and pain research at Washington, will lead the study. Their team will explore ways of improving the design of clinical trials for pain drugs.

FDA’s Bob Rappaport, who heads the agency’s Division of Anesthesia, Analgesia, and Addiction Drug Products, says the design of trials may be at the core of the problem. “When opioids that have been known to be effective for hundreds of years are put in clinical trials,” says Rappaport, “we can’t get a positive result.” Rappaport adds, “It has become clear to the entire pain community that there are design problems with the trials.”

Dworkin hypothesizes that a possible reason pain clinical trials are often unsuccessful is that control group patients in the trial, who get a placebo (dummy) pill instead of the real treatment, frequently show greater-than-expected improvements. Researchers then find it difficult to show meaningful differences between the pain-lessening effects of the real drug and placebo drugs. “It could just be positive, ongoing interactions with a really nice nurse,” says Dworkin, “that is leading to this effect — we don’t know.”

The team plans to investigate many factors that may play a role, such as the patient’s pain intensity and duration, the way studies are planned — e.g., the length of a trial and frequency of patient visits — and characteristics of the study site, such as the experience and training of the lead investigator and staff.

Other factors under consideration by the researchers involve the accuracy of patients reporting their pain, for example the ability of patients to precisely gauge their pain on standard 0-10 scales used in most studies.

The team plans to review FDA databases with information from hundreds of pain clinical trials, a resource not often used by researchers. They will also analyze previously published pain clinical trials and data from studies sponsored by pharmaceutical companies.

Read More: New Initiative to Speed Pain Treatments

*     *     *