FUNDAMENTAL DILEMMAS OF THE RANDOMIZED CLINICAL-TRIAL PROCESS - RESULTS OF A SURVEY OF THE 1,737 EASTERN-COOPERATIVE-ONCOLOGY-GROUP INVESTIGATORS

Purpose: We studied oncologists' attitudes and behavior with regard to their participation in randomized clinical trials. Methods: We survey ed the 1,737 physician members of the Eastern Cooperative Oncology Gro up (ECOG) using the Physician Orientation Profile (POP), a self-admini stered mailed questionnaire. A response rate of 86% was achieved (1,48 5 of 1,737); each physician's actual patient accrual was recorded. Res ults: All respondents indicated that they had a systematic pattern of patient preselection for entry onto trials beyond the formal inclusion /exclusion trial criteria. Eighty-nine percent stated that improving p atient qualify of life rather than prolonging survival was more person ally satisfying. Sixty-two percent did not enter a single patient duri ng the 12-month period following the survey, while 10% entered 80% of all patients during that time. Physicians overestimated their accrual rate by a factor of 6. Eighty-three percent defined randomization and adherence to trial protocol as a serious challenge to their ability to make individualized treatment decisions. Conclusion: This study raise s questions regarding the following: (1) the perceived generalizabilit y of trial findings, (2) the role of end points other than survival fo r clinical trials, (3) the consequences of physician overestimation of patient accrual, and (4) the impact of randomized trials on the behav ior of clinicians. Further investigation into these critical issues wi ll provide meaningful recommendations to enhance the future design, im plementation, and conduct of randomized clinical trials in cancer. (C) 1994 by American Society of Clinicol Oncology.