陈峰, 孙华龙, 沈彤, 于浩. 数据管理与统计学的关系J. 药学学报, 2015,50(11): 1420-1424.
引用本文: 陈峰, 孙华龙, 沈彤, 于浩. 数据管理与统计学的关系J. 药学学报, 2015,50(11): 1420-1424.
CHEN Feng, SUN Hua-long, SHEN Tong, YU Hao. Relationship of statistics and data management in clinical trialsJ. Acta Pharmaceutica Sinica, 2015,50(11): 1420-1424.
Citation: CHEN Feng, SUN Hua-long, SHEN Tong, YU Hao. Relationship of statistics and data management in clinical trialsJ. Acta Pharmaceutica Sinica, 2015,50(11): 1420-1424.

数据管理与统计学的关系

Relationship of statistics and data management in clinical trials

  • 摘要: 一个理想的临床试验必须做到科学的试验设计、严格的实施、完善的质量管理、没有争议的分析结果和可接受的风险效益比。为了达到这一要求, 临床试验从设计到实施, 从分析到总结, 都必须把质量控制的理念融入其中。而数据管理中的质量控制离不开统计学思维和方法。本文从统计学角度论述了数据管理与统计学的关系, 并强调了数据管理中必须应用统计思维和统计学方法, 以提高数据管理的质量。

     

    Abstract: A perfect clinical trial must have a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.

     

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