A large private university hospital system. The Johns Hopkins Oncology Center.

Clinical trials are a major commitment for a university-based comprehensive cancer center. In 1992, The Johns Hopkins Hospital registered 3508 new patients with cancer and, from this large population, 2880 patients were entered in clinical trials (many patients participated in more than one protocol). The Oncology Center, one of many departments at Johns Hopkins that conducts clinical research, participates in phase I and II new drug trials, phase III comparative studies, and, increasingly, in epidemiologic and prevention research. This calls for much broader participation by community hospitals and for many more patients who normally would not come to Johns Hopkins for their care. There are more than 100 protocols available from the Eastern Cooperative Oncology Group, but Johns Hopkins may participate in no more than 20 at any given time. Thus, every research facility must be selective about the trials in which it participates, given the finite number of hours, dollars, and resources available to carry out these programs. The institution provides safeguards to protect the interest of the patient. These include review and annual overseeing of the concept, design, and specifics of the proposed study. The pharmacy and nursing staff play an important role in control of chemotherapy distribution and use. Patients and physicians, however, must understand the questions the study is asking and agree that they are worth answering. There are problems in motivation; information; costs to the patient, hospital, insurers, and the physician; the concept of the placebo; and informed consent. Clinical research is the most ethical way to test drugs, radiation therapy, surgical procedures, or other new treatments. The clinical trial must meet rigorous criteria of design, conduct, and analysis. The patient must understand the issues and be a volunteer. We must make every effort to help patients and physicians get information about clinical trials and to participate if they choose.