Utilization of Non-clinical Electronic Data (1) An Overview - Potential of Accumulated SEND Data: Its Application to Historical Control Data and Virtual Control –

DOI
  • SATO Gen
    Non-Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association Eisai Co., Ltd.

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  • 非臨床電子データ活用（１）総論　～蓄積SENDデータの可能性：背景値，バーチャル対照群への応用～

Abstract

<p>The concept of digital transformation (DX) was proposed in 2004, and in 2018, the Ministry of Economy, Trade and Industry (METI) announced the “DX Promotion Guideline” which various industrial fields have been required to implement. The pharmaceutical industry is not exempt, and the frequency of seeing the keyword “DX” in our industry news is in fact increasing. The single word “DX” in the pharmaceutical industry covers many types of data ranging from manufacturing (plant) to marketing (sales). Furthermore, research data on this topic includes both human (clinical) and animal (non-clinical) data. </p><p>In this presentation, I will introduce the concepts and some practical ideas as an overview of data utilization in the non-clinical field. We will look at the general flow of data utilization through case studies using SEND data, a non-clinical CDISC standard. In addition, I would like to introduce the discussion that our team at JPMA has had regarding the possibility of applying accumulated SEND data to the management of background values and virtual control groups.</p>

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