T/CACM 015.7-2017 Statistical analysis of Chinese medicine clinical research operation technical specifications

Scope

Main technical content: Clinical research on traditional Chinese medicine (TCM) involves studying the effects of TCM on the disease process and prognosis through samples. The design of clinical research must apply statistical principles to make reasonable and effective arrangements for research-related factors, conduct scientific and reasonable analysis of research results, and minimize research errors to improve research quality. Therefore, statistical analysis is a key step in clinical research. Correct statistical analysis methods, reasonable statistical analysis processes, and rigorous interpretation of statistical analysis results are principles that must be followed in the statistical analysis process and are also one of the foundations for ensuring the reliability and scientificity of clinical research conclusions. There are technical guidelines for statistical analysis of drug clinical trials at home and abroad [1-9], which are used to ensure that statistical analysis results can truly and reliably reflect the performance of drugs. However, these regulatory documents only provide principles and lack technical specifications that can be implemented. Developing relevant technical specifications is conducive to translating statistical analysis of TCM clinical research into specific and feasible operating procedures, filling the gap in technical specifications for statistical analysis of TCM clinical research. This standard is formulated in accordance with relevant laws and regulations and technical documents such as the "International Coordinated Technical Requirements for Human Drug Registration: Statistical Guidelines for Clinical Trials (ICH E9)", the "Good Clinical Practice for Drug Clinical Trials", and the "Biostatistical Guidelines for Drug Clinical Trials", combined with the characteristics of TCM itself and the actual situation in China, to ensure the requirements for the collection, processing, analysis, and reporting of TCM clinical research data.

Development Information

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