Selection factors in clinical trials: results from the Community Clinical Oncology Program Physician's Patient Log

Between August 1984 and November 1985, data concerning 44,156 newly diagnosed cancer patients were entered in the Community Clinical Oncology Program Physician's Patient Log. Forty percent (17,773 patients) had a National Cancer Institute-approved protocol available for site and stage of disease. Fifty-six percent of patients with a protocol available were clinically eligible and 19% were entered on protocol. Thus, one-third of clinically eligible patients were entered in the study. Age was a major factor influencing eligibility and entry on study. Eighty percent of patients less than 25 years of age with a protocol available were clinically eligible for clinical trials participation, and 58% were placed on protocol. Patients greater than or equal to 65 years of age with a protocol available were less likely to be clinically eligible (48%) or placed on study (14%). A physician's preference for an alternate treatment and patient refusal for protocol treatment were also important reasons that clinically eligible patients were not registered on protocol. Selection for clinical trials participation affects the characteristics of patients under study and may have an impact on the ability to generalize the results of clinical trials.