Who should be responsible for the statistical analysis of clinical trials?

When the trial is completed, the supervisor will take back the original page of the case report form (the first page of the carbon free copy), and then the trial data will be input into the database and statistically analyzed by the biostatistician according to the statistical plan formulated before the trial. All subjects taking the trial drug will be analyzed (intention to treat analysis). Biostatisticians will provide formal statistical reports to report statistical results and attach all data tables. This report will be integrated into the final clinical trial summary report. The trial summary report is a detailed summary after the completion of the trial, including the test methods and materials, the description and evaluation of the results, statistical analysis, and the final obtained confirmatory, ethical, statistical and clinical evaluation report. The report should be written by the investigator. If it is a multicenter trial, it should be completed by the principal investigator. If the sponsor or the sponsor entrusts the contract research organization to write the report, the summary report shall be reviewed by the researcher, and the final draft shall be signed and dated to ensure the authenticity and accuracy of all the contents of the report.