SEND and its utilization

<p>The PMDA Regulatory Science Center was established in Apr 2018 as one of the key components of the government’s Healthcare Policy (partially amended on 09 Apr 2021). The Regulatory Science Center focuses on the collection and analysis of electronic data not only from clinical trials, but also for nonclinical studies (https://www.pmda.go.jp/review-services/drug-reviews/about-reviews/p-drugs/0003.html). As of February 2022, submission of nonclinical data in Japan is not required to be in SEND format, a non-clinical CDISC standard. However, PMDA may consider utilizing both clinical and non-clinical CDISC standard data in an integrated manner in the future since it may help to improve the quality of dossier review, implementation of safety measures, and creation of new guidelines.</p><p>At this symposium, we plan to present how clinical, as well as nonclinical CDISC standard datacan be utilized to efficiently develop safer new drugs. This presentation will focus on nonclinical aspects, and will cover the utilization of SEND from the following perspectives: regulatory review at the time of clinical introduction, approval for manufacturing and marketing, integrated analysis with clinical data, contribution to 3Rs by optimization of non-clinical studies (i.e., reduction of control group, etc.), utilization of accumulated data, and impact on the future of nonclinical trial guidelines.</p>