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Bringing Clinical Trials to the Communityby Ellen McDonald, PhD
Even if your practice is hundreds of miles away from a university hospital or cancer center, your cancer patients can still have the opportunity to participate in cutting-edge clinical trials close to home, thanks to the National Cancer Institute’s (NCI) Community Clinical Oncology Program (CCOP). The CCOP was conceived over 20 years ago as a way to make the most promising clinical trials accessible to more people throughout the country. Most of the top, federally sponsored research programs are at major cancer centers or in regional cooperative groups, but most cancer patients are treated by local oncologists or primary care physicians. This program brings the two together, linking more than 4,000 community practitioners to cancer research initiatives in a network of CCOP research bases around the country. The University of Texas M. D. Anderson Cancer Center is one such research base. The NCI funds and trains local and regional physician groups and hospitals that serve as CCOP sites, as well as the cancer centers or cooperative groups conducting the studies and serving as research bases. Each of the 63 CCOP sites is allied with several research bases—typically, with two or three cooperative groups (e.g., the Southwest Oncology Group) and one or two cancer centers. For physicians in private practice, this means access to a national network of cancer clinical trials that are ultimately funded and overseen by the NCI and administered by leading research centers like M. D. Anderson Cancer Center. Without traveling far from home, their patients may be able to take part in trials of new treatments, symptom control, or cancer prevention interventions available at the nearest CCOP site. Ideas for trials that are conducted through the CCOP program originate from faculty and physicians at the research base as well as from physicians at local CCOP sites. Symptom control and prevention studies are ideal. “Getting a trial approved for the program is a bit like negotiating a treaty,” said Michael J. Fisch, M.D., the medical director of the CCOP Research Base at M. D. Anderson. “We first suggest the concept, the gist of what we plan to do, and if the NCI approves the idea, we then supply a detailed protocol. After NCI approval, our own institutional review board has to approve the proposed study. The CCOP sites we’ll be working with also participate in the development of the study, as well as industry sponsors who will supply the new agent or product under investigation. And exactly how one brings all these people together in the process and in what order, well, there’s a bit of an art to that.” Since it was first funded in 1987, the M. D. Anderson CCOP Research Base has managed 150 CCOP-associated clinical trials involving more than 5,000 patients. It is affiliated with 24 general CCOP sites and two minority-based sites. The program’s success is partly due to recent trends in cancer management. “In recent years, cancer care has moved a lot more towards outpatient care,” Dr. Fisch observed. “For example, many of the new molecularly targeted therapies are oral therapies that can be administered easily on an outpatient basis. Therefore, the possibility of doing research with patients in their own communities has become much more feasible, and institutions such as M. D. Anderson are increasingly turning outward in their research thinking.” Whatever the benefits of participating in clinical trials offered by CCOP, they are of little use if community physicians and the general public are reluctant to enroll. Therefore, making the community more aware of the state of cancer research in general and of the advantages of participating in clinical trials in particular is one of the goals of the national CCOP program. “We want people to realize that being in a CCOP clinical trial means they will receive first-class medical treatment,” noted Dr. Fisch. “You couldn’t get better quality medical treatment than to be in a trial sponsored by the NCI. Sometimes people fear being used as ‘guinea pigs’ in experiments, but it’s not like that. Patients enrolled in these trials always get at least the best treatment available, and some, if not all, will also get the new intervention being tested. Patient care in the context of clinical trials is very closely monitored: it’s as careful as it gets.” Besides the advantages offered to patients who would not otherwise have easy access to clinical trials, CCOP also provides a clear advantage to those conducting the studies. “If we at M. D. Anderson hit upon what we think is a promising new treatment, CCOP provides a mechanism for us to do larger studies and see if our findings hold true for patients in the community,” explained Charles Lu, M.D., an associate professor in the Department of Thoracic/Head and Neck Medical Oncology at M. D. Anderson. Dr. Lu is currently conducting a phase III study in patients with locally advanced, unresectable non-small cell lung cancer through the institution’s CCOP Research Base. “For single-center studies, especially those at a specialized cancer center, the patient population may be highly select and not representative of the general population. CCOP allows us to take our idea to the next level and see if our findings can be generalized in another, larger patient population. That’s very valuable.” There are also benefits for the CCOP sites. “I see the main advantage of being a CCOP site as the opportunity to participate in cutting-edge science and improve cancer care,” said Peggy Verrill, administrator of the Central Illinois CCOP. “Also, in my experience, patients are relieved to find that they don’t have to travel long distances to participate in the most current studies available.” Most of the major successes of the NCI’s CCOP thus far have involved cancer prevention studies with findings that have since changed standard practice. For example, few people had heard of tamoxifen before 1998, when the Breast Cancer Prevention Trial showed 45% fewer breast cancer diagnoses in women at increased risk for the disease who took tamoxifen for chemoprevention. Likewise, results from the Colorectal Adenoma Prevention Study reported in 2002 showed that daily aspirin use in patients with a totally resected early-stage colorectal cancer reduced subsequent adenoma development compared with placebo. In addition, in 2003, the Prostate Cancer Prevention Trial showed that finasteride reduced the risk of prostate cancer in healthy men age 55 or older. These headline-making trials were available to patients at CCOP locations throughout the country, allowing them to reap the benefits of participating in the latest clinical trials in their own hometowns and the rewards of having access to these new treatments before they became standard therapy.For more information on this topic or for questions about M. D. Anderson’s treatments, programs, or services, call askMDAnderson at (877) MDA-6789. Other articles in OncoLog, February 2006 issue:
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