Cancer Centers Seek Greater Enrollment in Early Clinical Trials

Researchers from National Cancer Institute (NCI)-designated Cancer Centers met in Denver last month to share preliminary findings from seven pilot studies aimed at increasing participation in early phase clinical trials, particularly among elderly and underserved populations.

The meeting was the third workshop organized under the 2003 NCI-led initiative, "Overcoming Barriers to Early Phase Clinical Trials." The workshops allow grantees to exchange ideas on why certain groups do not join phase I and II clinical trials and what can be done about it.

"We are looking at a variety of different approaches for overcoming barriers, and it's important to say at this point that the initiative is still a work in progress," said Dr. Edward Trimble of NCI's Division of Cancer Treatment and Diagnosis. Among the strategies being tested are the use of counselors to guide patients through the clinical trials process, community education programs, and equipping oncologists with Personal Digital Assistants (PDAs) so they can identify open trials during office visits with patients.

Early phase clinical trials determine which agents enter the clinical pipeline and are eventually tested in larger studies. Different groups may respond to treatments differently, so broad participation in early trials is critical. For example, the lack of participation among patients over the age of 65 - many of whom may take several medications - could pose a public health challenge in the years ahead.

"The population is aging, and we need to do a better job defining the appropriate doses and toxicity of the agents we use to treat cancer," said Dr. Michele Basche of the University of Colorado Health Services Center. Her team found that logistical barriers, such as transportation, often prevent older patients from joining trials.

The "Overcoming Barriers" initiative was launched 18 months ago as a public-private partnership supported by NCI; the Association of American Cancer Institutes; Friends of Cancer Research; the Foundation for the National Institutes of Health (NIH); and five pharmaceutical companies: Aventis, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, and Novartis.

During the project's planning stages, NCI-designated Cancer Centers were the obvious choice to carry out the initiative, according to Dr. Linda Weiss, chief of NCI's Cancer Centers Branch. "The Centers are really a clinical trials powerhouse because they have strong links to local communities and also to drug companies and NCI," she said.

NCI-designated Cancer Centers provide the majority of patients for NCI clinical trials, and they "certainly provide a large measure of intellectual leadership in our clinical trials program," noted Dr. Trimble. "NCI relies heavily on the doctors, nurses, and data managers in our Cancer Centers to help conduct trials."

The "Overcoming Barriers" initiative is funding projects at Baylor College of Medicine; Ohio State University; Massachusetts General Hospital; Washington University, St. Louis; University of California, Davis Cancer Center; University of Colorado Health Services Center; and University of Pittsburgh Cancer Institute.

The initiative may be extended beyond its originally scheduled end date of August 2005. Final results and recommendations will be reported at major scientific meetings and disseminated through the popular press and scientific literature.

By Edward R. Winstead