Physicians Urged to Encourage Clinical Trial Participation

ROME—A panel of cancer experts has called upon clinicians to do more to inform and counsel their patients about clinical trials. The plea was voiced during a webcast discussion sponsored by the Susan G. Komen Breast Cancer Foundation and held at the 5th Annual Multidisciplinary Symposium on Breast Diseases.

“We need to do a better job of educating people about why clinical trials are important,” said Diana Rowden, immediate past chairman of the Komen Foundation Board of Directors. She added that potential participants must be assured about the scientific rigor and safety of any trial.

Rates of involvement in clinical trials are low in the United States, compared to many European countries, according to Komen Foundation President Susan Braun, who moderated the discussion. Fewer than 5% of adult cancer patients in the United States participate in new drug trials, she said. Lack of patient education about clinical trials in general is thought to be a factor.

“There is a misconception, particularly among Americans, that if you’re on a trial, you are somehow receiving an inferior treatment,” said David Page, MD, professor of pathology and epidemiology, Vanderbilt University. In fact, he asserted, participants in randomized trials are assigned to one of “the two best possible treatments that could be offered. They are getting state-of-the-art care.”

Time Burden

Participation in clinical trials represents a time burden on physicians, panel members acknowledged, beginning with discussing the possibility with patients.

“It takes some time to have this conversation,” said Patricia A. Ganz, MD, of the Jonsson Comprehensive Cancer Center, UCLA. “We hope to have that kind of involved conversation with every patient, even if it isn’t related to a trial, but then adding the trial on top of that extends it.”

Dr. Page observed that having patients enrolled in a clinical trial presents practical difficulties. “There’s a need for support staff. You need to spend time explaining the trial; you need to be able to collect data.”

He commended the Komen Foundation’s Project CRAFT, which provides funding to surmount that barrier. Project CRAFT, which stands for Clinical Research—Affiliates Funding Trials, was begun in 1999 to increase participation in and access to NCI-approved cancer trials. It will provide financial support for aspects of trials not typically funded by government or institutional sources.

“This helps create an infrastructure so that doctors can enter their patients in a trial without interfering with their daily practice,” Dr. Page said.

Dr. Ganz concluded, “We’re very fortunate that there are usually enough trials available to cover various forms of breast cancer.” Still, she acknowledged, “Not everyone wants to go into an experimental study, and I think a woman who does is extremely courageous.”