癌症研究中的临床试验。
Clinical trials in cancer research.
作者信息
Gehan E A
出版信息
Environ Health Perspect. 1979 Oct;32:31-48. doi: 10.1289/ehp.793231.
This is a review paper which gives a discussion of various aspects of clinical trials in cancer research. Since the conduct of the first randomized controlled clinical trial in cancer patients in the mid-1950's, substantial progress has been made in the utilization of the clinical trial technique for the evaluation of therapeutic efficiacy. The important elements of a protocol are given with some discussion of items to be considered in designing a protocol. The types of clinical trial (phase I, II, III) are defined, and the place of each phase of study in the context of the search for new treatments is delineated. A comprehensive discussion is given of the elements in the comparative clinical trial (phase III), including objectives, consierations in planning (comparability of treatment groups stratification of patients, feasibility and size of study, and prospective versus retrospective studies). Brief descriptions are given of designs for comparative clinical trials and a trial in oat cell lung carcinoma is discussed in some detail. Finally, some comments and references are given concerning the analysis of clinical trials.
这是一篇综述论文，讨论了癌症研究中临床试验的各个方面。自20世纪50年代中期在癌症患者中开展首个随机对照临床试验以来，在利用临床试验技术评估治疗效果方面已取得了重大进展。文中给出了方案的重要要素，并对设计方案时需考虑的项目进行了一些讨论。定义了临床试验的类型（I期、II期、III期），并阐述了每个研究阶段在寻找新治疗方法背景下的位置。对比较性临床试验（III期）中的要素进行了全面讨论，包括目标、规划时的考虑因素（治疗组的可比性、患者分层、研究的可行性和规模以及前瞻性研究与回顾性研究）。简要描述了比较性临床试验的设计，并详细讨论了一项燕麦细胞肺癌试验。最后，给出了一些关于临床试验分析的评论和参考文献。
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