Home > Dr. Ward's Newspaper Column Home > 2010
System for conducting cancer clinical trials may reach crisis point
June 01, 2010As this article is published I will be at the American Society of Clinical Oncology Annual Meeting (ASCO) in Chicago. This meeting will draw over 20,000 oncologists from around the world to share the latest advances in the war on cancer. It always holds promise of something new and exciting. However, if a recent report, commissioned by the National Cancer Institute (NCI) and performed by the Institute of Medicine (IOM) is to be believed, "the system for conducting cancer clinical trials in the United States is approaching a state of crisis."
This is uniquely evident at the premier "American" cancer meeting. Every year there are fewer U.S. trials of import as the meeting is dominated by European, Japanese and even Chinese research. The IOM's report explains why and provides a basic recipe that all of us — institutions, physicians and patients — can play a part in.
For the past 50 years, the workhorse of advancing the application of new science to the patient's bedside has been the Clinical Trials Cooperative Group Programs. There are 10 Clinical Trial Co-ops in the United States involving more than 3,100 institutions and 14,000 investigators that enroll more than 25,000 patients in clinical trials each year.
Other research is done as well. The pharmaceutical industry sponsors trials designed to develop drugs and bring them to market. Private research groups, the largest of which is US Oncology (USON), Puget Sound Cancer Center's management and research partner, have demonstrated the ability to do high quality research that is largely outside of the government's infrastructure. We are proud to be part of the research we do with USON, but they only augment the work we have done with cooperative groups.
The strength of the cooperative groups has been the extensive involvement of physicians and patients treated from diverse communities and treatment settings, allowing results to be applicable to the general population. In addition, they have traditionally focused on questions that the private sector equipment manufacturers and pharmaceutical companies largely avoid, such as head-to-head trials of agents or regimens that are already approved for clinical use, evaluating combination therapies that involve two or more drugs from competing drug companies, studying new uses of generic drugs, and evaluations that seek to find treatments where less may be better. Last month I wrote of the promise of tailoring therapy to a cancer's genetic profile. That promise will only be fulfilled if we have "the ability to conduct the timely, large-scale, innovative clinical trials needed to improve patient care," according to the IOM report.
Unfortunately the IOM found that the co-ops are burdened by redundancy, bureaucracy and competition, both within and between groups. Governmental oversight similarly is convoluted, overlapping and often over-reaching, and yet there is no system in place to prioritize studies in order of importance. It takes over two years to bring a clinical trial through the approval process to enroll the first patient. Such delays often lead to trials that then languish without enrollment, and fewer than 60 percent of NCI-sponsored trials are ever completed, "a terrible waste of human and financial resources."
And there is no budget for wasting money. NCI funding for cooperative group clinical trials pays for less than half the actual costs; the rest is borne by the hospitals, clinics, and physicians who participate in these trials. While the costs of trials, particularly the inclusion of molecular profiling, are climbing, the funding for cooperative groups has dropped by 20 percent since 2002. Physicians, tightening their belts in the face of health care reform-induced reimbursement cuts by CMS and private insurance, find themselves increasingly unavailable to participate in research. This is only compounded when loopholes in the governance of the insurance industry allow some plans decline to payment for any of the care of patients enrolled in clinical trials, hindering enrollment and participation of patients, and further burdening physicians who may enroll patients whilst unaware of the fine print in their policy.
The IOM's recommendations are broad and general: "Improve the speed and efficiency of the design, launch and conduct of clinical trials. Incorporate innovative science and trial design into cancer clinical trials. Improve the means of prioritization, selections, support and completion of cancer clinical trials. Incentivize the participation of patients and physicians in clinical trials." They do not intend that the baby be thrown out with the bathwater, but they do call for a massive overhaul.
Until we give heed, I will increasingly find myself attending an American meeting to listen to results from Italy, France, Poland and Japan that I will then try to apply to the cancer patients of the Puget Sound. And that's an experiment I don't want to enroll my patients in.
Dr. Ward is a medical oncologist at Puget Sound Cancer Centers. He can be reached at (425) 775-1677.