Abstract: Objectiv eTo explore the applicability of real-world study designs in post-marketing drug safety evaluation so as to improve the rationality of clinical drug use and ensure drug safety. Methods Theories on real-world study were used. The applications of commonly used study designs in post-marketing evaluation of drug safety were described in detail along with case analysis. Results In post-marketing evaluation of drug safety, the most commonly used type of design of experimental studies was the pragmatic randomized controlled trial. Common types of design of analytical studies included cohort study, nested case-control study and case-control study. Common types of design of descriptive studies included cross-sectional survey, case series and case reports. Among these types of design, the pragmatic randomized controlled trial, cohort study, and nested case-control study could be used to infer the causal relationships between drug exposure and medical events. Other types of design could do nothing more than establish hypotheses for causal associations due to their weak validity. Conclusion Real-world study designs have been widely used in post-marketing evaluation of drug safety. Compared with explanatory randomized controlled trials, they are closer to the real clinical environment and attaches more importance to drug safety so as to ensure the safety of medication.

Key words: real-world study designs, drug safety evaluation, post-marketing