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| 统计在生命科学中的实践与认识(Ⅵ) 临床试验(上) | |
| 引用本文： | 汤旦林 武俊青. 统计在生命科学中的实践与认识(Ⅵ) 临床试验(上)[J]. 数理统计与管理, 1997, 16(6): 59-63 |
| 作者姓名： | 汤旦林 武俊青 |
| 作者单位： | 中日友好医院，山西医科大学卫生统计教研室 |
| 摘 要： | 本文回顾了临床试验发展的简史、随机临床试验的主要特征、临床试验实践中所面临的问题和困难，介绍了有关临床试验研究和应用的近展 |
| 关 键 词： | 治疗意向分析，大规模简单试验，行为学理论，生命质量，依从性 |
The Practice and Cognition of Statistics in Life Sciences(Ⅵ) Clinical trial(1) |
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| Tang Danlin Li Xiaoqiang. The Practice and Cognition of Statistics in Life Sciences(Ⅵ) Clinical trial(1)[J]. Application of Statistics and Management, 1997, 16(6): 59-63 | |
| Authors: | Tang Danlin Li Xiaoqiang |
| Abstract: | Over the past 40 years, despite of the vigorous criticism, the randomized control trial has still become recognized as a scientific gold standard for evaluating the effectiveness of clinical therapy. After reviewing the history of clinical trial, the key components of it are discussed. They are randomized treatment assignment, blinding, adequate sample size, intent-to-treat analysis, and testing of prestated hypotheses on mature data. Several recent developments related to clinical trials: interim monitoring boundaries, large simple trials, multi-center and meta-analysis, quality of life, compliance, and behavioral aspects of clinical trials, are highlighted here. Major obstacles to conducting randomized clinical trials, including knowledge and attitudes of potential participants, reimbursement problems, informed consent limitations, the problems of equipoise, are also discussed. |
| Keywords: | large simple trial intent-to-treat analysis compliance quality of life behavior theory. |
| 本文献已被 CNKI 维普 等数据库收录！ | |