In February 1999 a coalition of New Jersey legislators, consumers, providers and insurers signed an agreement to collaborate in expanding New Jersey health insurance coverage to include routine care rendered during participation in cancer clinical trials. Clinical research, as defined by Dr. Harold Varmus, Director of the NIH, is research conducted with human beings, including laboratory research on the mechanisms of human disease, clinical trials for preventive and therapeutic strategies, epidemiology, behavioral research, and health services and outcomes research. One area of clinical research toward which a large proportion of public and private investment is directed is clinical trials. Clinical trials are defined by Centerwatch, a clinical trials listing service , as a carefully designed investigation of the effects of drugs, medical treatment or devices on a group of patients.
Clinical trials occur in three phases.
I studies include a small number of healthy individuals to assess the drug s safety. Phase II studies involve larger groups mainly to test the efficacy of a drug. Phase III studies test drugs in several hundred to several thousand patients over many years for safety, dosage and effectiveness. Approximately 25 to 30 percent of experimental drugs pass all three phases of testing. This NCI Panel report, and others in biomedical research, point to managed care as a significant reason for dwindling clinical research resources.