Drug Evaluation Committee Points to keep in mind when using Real World Data as an external control for regulatory submissions
In recent years, the use of Real World Data (RWD) has been attracting attention. This task force focused on the use of RWD as an external control in pharmaceutical applications as one of the situations in which RWD can be utilized, and investigated past cases of application mainly from a statistical perspective.
As a result, we clarified various points to be considered in prior research and preparation and statistical methods when using RWD as an external control in pharmaceutical applications. This report summarizes the points to be considered when using RWD as an external control in regulatory applications, with the aim of promoting the appropriate use and utilization of RWD in future regulatory applications. We hope that this report will be of some help in the utilization of RWDs.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
Data Science Subcommittee 2021 Ongoing Task Force 1