一种常见临床试验安排中样本量的优化方法

An Optimization Method for Sample Sizes in the Clinical Trial

目的:提供一种优化临床试验中样本量的方法,使临床试验达到科学性、经济性与伦理学的统一。方法:利用一个实际的例子,对一种临床试验中常见的试验安排,分别使用传统和优化的方法计算样本量,以说明优化方法的合理性和必要性。结果:通过比较分析,优化方法能在保证科学性与伦理学的基础上,很好的减少投入成本。结论:对临床试验中样本量的优化措施是完全必要的也是完全可行的。

Objective. To enable clinical trials to science, economics and ethics ofunity, the author pro- vides an optimal sample size in clinical trialsmethods. Methods： Using a practical example, to calculate sam- ple size useing traditional methods and optimization method respectively, to illustrate the later is reasonable and nec- essary. Results.. Through comparative analysis, optimization methods can reduce input costs, based on ensuring sci- ence and ethics. Conclusion. To optimize the sample size in clinical trial is necessary and feasible.