Lee J Y, Marks J E, Simpson J R
Cancer Clin Trials. 1980;3(4):381-4.
One of the prerequisites for a successful clinical trial is the accrual of a sufficient number of patients for study. Because the sample-size requirements for a randomized clinical trial can rarely be met by a single institution in a short period of time, cooperative groups have taken in a major role in conducting clinical trials. In this paper, the recruitment of patients at our institution to a lung cancer clinical trial is evaluated. A total of 653 lung cancer cases were reviewed. Of the 77 cases which were eligible for the trial, 41 were accessioned. The reasons why eligible patients were not accessioned to the trial are discussed.
成功开展一项临床试验的前提条件之一是招募到足够数量的患者进行研究。由于单个机构在短时间内很少能满足随机临床试验的样本量要求,协作组在开展临床试验中发挥了主要作用。本文评估了我院将患者纳入一项肺癌临床试验的情况。共审查了653例肺癌病例。在符合试验条件的77例病例中,有41例被纳入。文中讨论了符合条件的患者未被纳入试验的原因。