"Increased penetration of managed care into the health care system in the United States presents both a problem and an opportunity for cancer care." This was the conclusion articulated by Dr. Harold Freeman, Chairman of the President's Cancer Panel, following a day of presentations by representatives of California, Oregon, and Washington Academic Health Centers, Community Clinical Oncology Programs, and managed care organizations. The July 30 meeting, which continued a constructive dialog between researchers and managed care institutions opened by the National Cancer Institute, was the first in a series of four meetings designed to explore how to maintain the capacity of clinical investigators to conduct cancer research, expand outreach activities and research dissemination, and improve geographic availability of quality cancer care nationwide in today' changing health care delivery environment. The meeting was held at the Fred Hutchinson Cancer Center in Seattle, Washington. The Panel is a three-member, Presidentially appointed advisory committee that meets regularly to assess the effectiveness of the National Cancer Program.

Declared in 1971, the "war on cancer," waged in part through patient access to clinical trials, has resulted in a substantial improved outlook for cancer patients. The President's Cancer Panel believes that Federal funding constraints and the impact of managed care on drug development, translational research, and clinical research threatens this outlook. The explosion in managed care is profoundly changing not only the way that medical services are delivered, but the way in which clinical research is conducted. This belief was supported by testimony heard at the July 30 meeting by Panel members and by Dr. Richard Klausner, Director, National Cancer Institute. Dr. Freeman acknowledged that "managed care has succeeded in controlling costs, but, in doing so, has brought about the rise of other problems. A medical care system which is predominately driven by the marketplace rather than by concerns for human benefit raises significant social, moral, and ethical questions related to advancing research and providing quality patient care."

Recurrent themes emerging from the day's discussions revealed both the "problem" and "opportunity" aspects of managed care. The managed care system, it was confirmed, is fully present and continues to be on the rise in the West and Northwest. Clinical trials are being affected. The research questions that are being asked are based on managed care's response-when no reimbursement is provided for experimental therapies, the type and number of patients that get into a trial are changed; the type of clinical trial that is conducted is changed; and the speed of the trial is changed. Dr. Freeman expressed the Panel's fear that the cost of research will be shifted to patients who can afford it. He said that this would limit our ability to know how research results would impact all patients and that "this must not be allowed to happen."

Certain valuable consequences have accompanied the managed care movement. Clinical researchers, agreeing that managed care is very likely here to stay, have accepted that they will be asked to provide more evidence of the added value and relevance of clinical trials to the health care delivery system. Approval from third party payers will depend, in large part, on well-thought-out, scientifically efficient, and cost-effective studies that propose to answer specific questions. The fact has forced a streamlining of study protocols and an elimination of some costly tests for protocol patients. Partnerships have been formed and collaborative efforts undertaken by cancer centers, insurers, physicians, and drug and biotech companies to reduce duplicative studies and resource depletion.

Some needs became evident from the day's discussions. The cancer research community, in its effort to educate the public, patients, insurers, providers, and lawmakers about the value of supporting clinical research have heretofore relied, to a large extent, on anecdotal data; hard data are needed. It is not enough, for example to say that patients are not entering into protocols; reasons for nonparticipation must be monitored and supported by data. Outcome and cost data are critical for contracts. Once information is available, improved techniques for disseminating that information are needed to allow immediate sharing of information across specialties, between physician and patient, and with the public. The results of research must be brought quickly to the bedside; it is difficult to convince the public of the significance of results when information is lacking.

Future meetings of the President's Cancer Panel to assess the impact of managed care on the war on cancer will focus on several major issues: standardization of language across all concerned parties, including a definition of managed care and a rearticulation of the definition of clinical research and what constitutes the various phases of clinical trials; the differential cost of delivering managed care versus traditional care; the impact on the quality of care of increasing outpatient care versus inpatient care; who will assume responsibility for payment for patients on clinical trials; and whether there are existing paradigms to guide the future direction of cancer research as it faces a changing health care delivery environment. The next meeting of the President's Cancer Panel is scheduled to be held in San Antonio, Texas, on September 24, 1996.

Speaking for the National Cancer Institute, Dr. Richard Klausner, Director, said that, for its part, the NCI must evaluate its own efficiencies before it can ask or expect cancer centers to be efficient. The process of examination has been set in motion, he said.

In a final concluding remark, President's Cancer Panel Chairman, Dr. Harold Freeman, observed that the American public is fickle. While it demands low-cost health care, it will tolerate neither low-quality care nor lack of access to the most advanced care. The question arises whether, in time, the system will be accepted as a growing number of sick patients experience the effects of managed care. In the final analysis, these factors may determine the future form or existence of the managed care system.