Begg C B, Carbone P P, Elson P J, Zelen M
N Engl J Med. 1982 May 6;306(18):1076-80. doi: 10.1056/NEJM198205063061803.
The Eastern Cooperative Oncology Group (ECOG) initiated a program in 1976 to involve community hospitals in multi-institutional clinical trials. The community hospitals can be characterized as generally having no tradition of participating in clinical trials of cancer therapy, whereas the ECOG member institutions are university hospitals or major treatment centers. More than 100 community hospitals participated in 97 randomized trials involving 4506 patients from November 1976 through February 1981. Comparisons between the community hospitals and the ECOG member institutions indicate that the quality of participation was similar, as measured by rates of ineligibility, compliance with the protocol, and submission of data. Objective measures of outcome, such as survival, response, and toxicity, were also comparable. We conclude that under the mechanism adopted by the ECOG, it is possible to include community hospitals in clinical trials of cancer therapy without reducing the quality of the data or compromising the therapeutic outcomes.
东部肿瘤协作组（ECOG）于1976年启动了一项计划，让社区医院参与多机构临床试验。社区医院的特点通常是没有参与癌症治疗临床试验的传统，而ECOG成员机构则是大学医院或主要治疗中心。从1976年11月到1981年2月，超过100家社区医院参与了97项随机试验，涉及4506名患者。社区医院与ECOG成员机构之间的比较表明，通过不合格率、方案依从性和数据提交率来衡量，参与质量相似。生存、反应和毒性等客观结局指标也具有可比性。我们得出结论，在ECOG采用的机制下，有可能将社区医院纳入癌症治疗临床试验，而不会降低数据质量或影响治疗效果。
