ISS and ISE Study Design
Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are important parts in clinical trials. In general, when applying for clinical research, the researchers should combine the pharmacy characteristics of the drug, the pharmacological and toxicological research results, the clinical indications, the population for taking drugs and the clinical trial literature, thus they conduct a comprehensive analysis of the feasibility, safety and effectiveness of clinical research on the drug, and propose the safety issues that need to be paid attention to in clinical research and the safety indicators that need to be monitored. The focus of ISS and ISE is on the overall understanding of the effectiveness and safety of the drug under study, based on a complete understanding of the results of drug research.
