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国际临床研究杂志

International Journal of Clinical Research

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International Journal of Clinical Research. 2024; 8: (3) ; 10.12208/j.ijcr.20240092 .

Statistical design and methods for clinical trials of new drugs
创新药临床试验统计学设计和方法

作者： 王燕妮, 孟凡强 *

翰博瑞强（上海）医药科技有限公司 上海

*通讯作者： 孟凡强,单位：翰博瑞强（上海）医药科技有限公司 上海；

引用本文: 王燕妮, 孟凡强 创新药临床试验统计学设计和方法[J]. 国际临床研究杂志, 2024; 8: (3) : 39-42.
Published: 2024/3/26 15:25:12

摘要

随着医药领域的不断发展，对于新药临床试验方案设计的科学性和可执行性也有了进一步的规范和要求。统计学是临床试验设计、数据分析和结论推断的核心内容，涉及样本量计算、统计学方法的选择、随机盲法实施、数据收集、清理、数据集映射到数据分析、统计报告的撰写等各个环节。本文从统计学的角度综述了新药临床试验设计和方法以及需要关注的内容，为我国创新药临床试验申办者提供参考。

关键词： 临床试验；设计；统计学方法

Abstract

With the continuous development in the field of medical research, there are further regulations and requirements for the scientific and executable design of clinical trial protocols for new drugs. Statistics is the core content of clinical trial design, data analysis, and conclusion inference, involving various aspects such as sample size calculation, selection of statistical methods, implementation of random blinding, data collection, cleaning, mapping of data sets to data analysis, and writing of statistical reports. This review summarizes the design and methods of clinical trials for new drugs from a statistical perspective and the content that needs attention, providing a reference for applicants of new drug clinical trials in China.

Key words： Clinical Trial; Design; Statistical Methods

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