Statistical Analysis Plan for Confirmatory Drug Clinical Trials

摘要

After preclinical research, the effectiveness and safety of new drugs are finally verified by human clinical trials. As an important tool for clinical trial design, implementation and analysis, statistics is becoming more and more important in innovative drug research and development. Based on the guiding principles of international and domestic regulators and industry consensus, this paper expounds the key issues that should be considered in the statistical analysis plan of confirmatory drug clinical trials.