DIA 2020 Global Annual Meeting

Medical reviewers are more sophisticated when evaluating the adverse events associated with treatment than the ICH E3 document reflected 25 years ago. A more modern approach for doctors at regulatory agencies and sponsors is to rely on statistical concepts such as relative risk, incidence rates, time to event and Bayesian statistics to make a more informed decision on the safety of patients in clinical trials. Summarizations using tables and graphs will be shared to illustrate these concepts.