Host: The Japanese Society of Toxicology
Name : The 50th Annual Meeting of the Japanese Society of Toxicology
Date : June 19, 2023 - June 21, 2023
DX is one of the ways to achieve the targeted goal. The goal of pharmaceutical companies to promote DX is to provide high quality drugs/services to patients as quickly as possible, and major changes are taking place around operations. Particularly in the field of clinical trials, DX is actively promoted mainly in Europe and the U.S., and the way clinical trials are conducted is changing dramatically, and the wave of this change is sweeping over Japan. One of these is the decentralized clinical trial (DCT), which decentralizes clinical trial operations by focusing on patient centricity, thus enabling patients to participate in clinical trials without depending on visits to the hospital. The development of digital biomarkers is also being activated, making it possible to collect continuous data for efficacy or partial safety evaluation without the patient having to visit the hospital. In addition, there have been reports of cases where Real World Data (RWD) has been used to obtain drug approvals, especially for rare cancers, and cases where the effectiveness of vaccines against Covid-19 has been verified using RWD outside of Japan. The environment for utilizing medical information data is beginning to progress in Japan. These are all considered to be examples that lead to the goal of promoting DX by utilizing digital technology and RWD, i.e., by promoting DX. The JPMA is actively conducting case studies, improving the environment, and making policy proposals to ensure that these methods are used without lagging behind overseas. In this symposium, I will introduce these cases, discussing the future prospects as well as exchanging opinions with researchers in non-clinical fields for the future activities.
