Witnesses Cite Importance of Participation in Clinical Trials
The House Government Reform Committee held a hearing on May 13 to examine the barriers to full participation in cancer clinical trials by eligible adults. Committee Chairman Tom Davis (R-Va.) began the hearing by noting that while 20 percent of adults with cancer are eligible for clinical trials, only 3 percent actually participate in them, too few to answer important questions about cancer treatment.
Dr. Michaele Christian, associate director of the Cancer Therapy Evaluation Program in NCI's Division of Cancer Treatment and Diagnosis described NCI's clinical trials program and initiatives to educate patients and community physicians about clinical trials through the Clinical Trials Education Series, the Cancer Information Service, and the clinicaltrials.gov Web site, the latter of which lists all government-sponsored trials and is designed to list industry-sponsored clinical trials as well. Dr. Richard Pazdur, director of the Division of Oncology Drug Products in the Center for Drug Evaluation and Research in the U.S. Food and Drug Administration (FDA) spoke about the FDA's efforts to expedite approval of cancer therapies and to work with other scientific and clinical organizations to increase participation of cancer patients in clinical trials.
One concern raised by members of the congressional committee was the pharmaceutical industry's reluctance to list all of their clinical trials on clinicaltrials.gov. The site is designed to provide regularly updated information about federally and privately supported clinical research on human volunteers. Speculation at the hearing was that some of the reluctance by companies to list their trials on clinicaltrials.gov may have to do with confidentiality concerns of the companies. It was reported during the hearing that many private trials are found on company Web sites, but with limited or incomplete information about patient eligibility and treatment protocols.
A second group of witnesses - Dr. Andrew Pecora of the Hackensack University Medical Center, Dr. Robert Comis of the Coalition of National Cancer Cooperative Groups, and Ms. Ellen Stovall of the National Coalition for Cancer Survivorship - described in detail some of the barriers to clinical trial participation. They said that lack of education and awareness by physicians and patients about the value of clinical trials was a major obstacle, noting that only 15 percent of adult cancer patients were aware that clinical trials participation was available to them.
The witnesses also noted that many patients, particularly those from minority populations, often distrust the type of treatment they will receive and fear the health risks involved. Patients commonly perceive that clinical trials are the last resort for treatment of aggressive cancer. Uncertainty about health insurance coverage is also a barrier to participation.