Taylor K M, Feldstein M L, Skeel R T, Pandya K J, Ng P, Carbone P P
York University, Department of Administrative Studies, Atkinson College, Ontario, Canada.
J Clin Oncol. 1994 Sep;12(9):1796-805. doi: 10.1200/JCO.1994.12.9.1796.
We studied oncologists' attitudes and behavior with regard to their participation in randomized clinical trials.
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.
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.
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.
我们研究了肿瘤学家对于参与随机临床试验的态度和行为。
我们使用《医生导向概况》（POP），通过自行填写邮寄问卷的方式，对东部肿瘤协作组（ECOG）的1737名医生成员进行了调查。回复率达到了86%（1737人中的1485人）；记录了每位医生实际招募的患者数量。
所有受访者均表示，他们在正式的纳入/排除试验标准之外，有一套系统的患者预筛选模式，以确定其是否适合进入试验。89%的人表示，提高患者生活质量而非延长生存期，会让他们个人更有满足感。62%的人在调查后的12个月内没有招募任何一名患者，而10%的人在那段时间内招募了所有患者的80%。医生们将自己的招募率高估了6倍。83%的人认为随机分组和遵守试验方案对他们做出个体化治疗决策的能力构成了严峻挑战。
本研究引发了以下几个问题：（1）试验结果的普遍适用性；（2）临床试验中除生存期以外的终点指标的作用；（3）医生高估患者招募数量的后果；（4）随机试验对临床医生行为的影响。对这些关键问题进行进一步调查，将为改进未来癌症随机临床试验的设计、实施和开展提供有意义的建议。
