Surgeons: A Future Role in Clinical Trials?

Clinical trials, particularly large cooperative group trials, establish the standards that we use to treat many of our cancer patients. The process by which multi-institutional clinical trials are developed, performed and peer-reviewed in the United States is equaled by few other countries around the world. Our clinical cooperative groups should be considered an important national resource. However, they stand at an embattled crossroads. Traditionally, only two to three percent of cancer patients have been entered onto clinical trials. In the past few years, national accrual has declined even further-from approximately 22,000 to 16,000 patients annually. The reasons for this decline are unclear. Although it could simply reflect a hiatus in the activity of some groups (such as the recent reorganization of the National Surgical Adjuvant Breast and Bowel Project [NSABP]), it more likely reflects changes in our health care environment. Few managed care insurance plans permit patient entry into clinical studies on the premise that trials increase patient care costs. Yet, individualized patient care not delivered according to strict peer-reviewed standards may cost more. While this remains undetermined, oncologists in both academic and private practice are being pressured to work harder for fewer rewards. They are being told that investigational treatments are not allowed even if trials evaluating these treatments may ultimately lead to better and more cost-effective patient care. This is a sad state of affairs at a time when, on one hand, treatment for many solid tumors remains desperately inadequate and, on the other hand, new insights into tumor biology promise to alter fundamentally our approach to cancer care. Where do surgeons fit into this picture? The cooperative groups were initiated in the mid-1950s, primarily to evaluate the potential role of chemotherapy in cancer treatment. During the past forty years, surgeons have usually played a supporting role in cooperative group trials with few notable exceptions, including studies performed by the NSABP, Gynecologic Oncology Group (GOG), and Lung Cancer Study Group (LCSG). Surgeons help enroll patients on study and oversee surgical quality control but infrequently design or coordinate studies, or lead the groups administratively. It is estimated that half of all solid tumors are appropriately treated by surgical resection, but most cooperative trials still focus on the management of advanced stage disease. If we are to impact the poor survival rates of the common solid tumors, our future agenda must be to test new biologically based treatment strategies in large numbers of patients. This requires that surgeons become more educated about clinical trial methodology and increase dramatically their participation in the entire clinical trials process. A recent surgical initiative may address some of these problems. This month, the American College of Surgeons will undergo a site visit for a grant application to develop a new, surgically based clinical cooperative group. Although regarded by some as a threat to the activities of the established cooperative groups, the American College of Surgeons Oncology Group (ACoSOG) potentially provides an answer to many of the problems currently surrounding large clinical trials. The ACoSOG is a sleeping giant. The American College of Surgeons is the parent North American surgical association with a membership of over 65,000 general surgeons and surgeons in all sub-specialties. Fellowship in the American College of Surgeons is a requisite of credible surgical practice in North America and in many countries around the world. Through its publications and national and state chapter meetings, the American College of Surgeons has unparalleled ability to educate surgeons and to support new directions in surgical practice. Surgeons are the portal of entry for many solid tumor patients into their cancer care. It will be difficult for any managed care system to argue with such a large group of physicians if they are educated in clinical trials methodology and committed to improving the care of their patients through cogent, surgically based protocols. Such protocols could examine the value of a new surgical technique of technology, could assess optimal methods of tumor staging or could ask biological questions using surgical specimens. The results of these surgical trials would directly affect the design of trials for more advanced malignancies coordinated by the other cooperative groups. Surgeons who participate actively in ACoSOG protocols (and are supported by appropriate funding for doing so) will probably support trials generated by the other cooperative groups with enthusiasm. This could solve a longstanding headache, namely, the pathetically small participation by surgeons in current cooperative group activities. None of this will happen overnight. Assuming the ACoSOG initiative is funded by the NCI, the administrative and educational efforts required to establish a successful cooperative group encompassing all surgical disciplines are daunting. Many years will be necessary to bring such efforts to maturity in a smoothly functioning organization. However, the ACoSOG has the opportunity to provide a new force, energy and vision in clinical trials which could radically change our approach to patient care and could greatly strengthen the activities of the current cooperative groups.