製薬企業から見た医薬品開発の現状と課題―Real World Dataの期待を中心に―

抄録

Pharmaceutical companies have high expectations for the use of Real World Data (RWD) in drug development. There have been the issues of long–term duration taken, large amount of costs required and low success rate for a drug to be approved. One of the solutions is to utilize an accumulated RWD in daily clinical practice. The use of RWD has being promoted around the world, and the new coronavirus infection pandemic has accelerated its efforts. In May 2022, the European Union released the European Health Data Space (EHDS) Initiative and Bill, and clearly indicated a policy that links medical data of EU citizens and that will be used not only for their own health management but also for medical, administrative, and R&D. In Japan, the government declared the Healthcare DX Reiwa Vision 2030 in 2022 and began putting a lot of efforts into promoting the Healthcare DX. Japanese RWD has been decentralized for data management and to make full use of RWD is necessary to establish the medical information infrastructure for RWD and legal arrangement to enable it with reference to EHDS. Japan's RWD has more attractive characteristics than those of other countries. I believe that once evidence generation system which enables the full use of Japanese people's RWD would be established, it will lead not only to the future medicinal advancement and sustainability of medical care in Japan but also provide excellent insight to the world.