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2016-10-10
Guidelines for planning and reporting drug clinical trial data management and statistical analysis

Standardized data management plan is helpful to obtain true, accurate, complete and reliable high-quality data, while detailed statistical analysis plan helps to ensure that the statistical analysis conclusion is correct and convincing. In order to ensure the quality of clinical trial data and scientifically evaluate the effectiveness and safety of drugs, it is necessary to make a detailed plan for data management and statistical analysis principles in advance. At the end of the trial, it is very important to summarize the data management and statistical analysis in the trial. The data management report truly reflects the data quality and test sample characteristics in the process of clinical trial, and provides the main basis for the content and research conclusion of the clinical trial summary report through the statistical analysis report. Therefore, the regulatory authorities regard the data management plan and report and statistical analysis plan and report as important documents and basis for evaluating the results of clinical trials in the drug market registration.

Although China's "good clinical practice" Practice (GCP) has specified the principle requirements for the data management and statistical analysis of drug clinical trials, and the corresponding technical guidelines on drug clinical trials and statistics issued by the State Food and drug administration also involve the main links of data management and statistical analysis, but there is no detailed data management plan and report, statistical analysis plan and report Technical specifications and guiding suggestions. Therefore, this technical guidance principle has carried on the more detailed introduction and the elaboration, and proposed the concrete request, aims at providing the technical guidance for the clinical trial data management and the statistical analysis personnel, helps them to complete the related work better, achieves the supervision request.