Journal of Clinical Oncology, Vol 12, 1796-1805, Copyright © 1994 by American Society of Clinical Oncology
Fundamental dilemmas of the randomized clinical trial process: results of a survey of the 1,737 Eastern Cooperative Oncology Group investigators
KM Taylor, ML Feldstein, RT Skeel, KJ Pandya, P Ng and PP Carbone
York University, Department of Administrative Studies, Atkinson College, Ontario, Canada.
PURPOSE: We studied oncologists' attitudes and behavior with regard to
their participation in randomized clinical trials. METHODS: We surveyed the
1,737 physician members of the Eastern Cooperative Oncology Group (ECOG)
using the Physician Orientation Profile (POP), a self- administered mailed
questionnaire. A response rate of 86% was achieved (1,485 of 1,737); each
physician's actual patient accrual was recorded. RESULTS: 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 patient quality of life rather
than prolonging survival was more personally satisfying. Sixty-two percent
did not enter a single patient during 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 raises questions regarding the following: (1) the
perceived generalizability of trial findings, (2) the role of end points
other than survival for clinical trials, (3) the consequences of physician
overestimation of patient accrual, and (4) the impact of randomized trials
on the behavior of clinicians. Further investigation into these critical
issues will provide meaningful recommendations to enhance the future
design, implementation, and conduct of randomized clinical trials in
cancer.
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