| アブストラクト | In Japan, an increasing interest in real-world evidence for hypothesis generation and decision-making has emerged in order to overcome limitations and restrictions of clinical trials. We sought to characterize the context and concrete considerations of when to use Medical Data Vision (MDV) and JMDC databases, the main Japanese real-world data (RWD) sources accessible by pharmaceutical companies. Use cases for these databases, and related issues and considerations, were identified and summarized based on a literature search and experience-based knowledge. Studies conducted using MDV or JMDC were mostly descriptive in nature, or explored potential risk factors by evaluating associations with a target outcome. Considerations such as variable ascertainment at different time points, including issues relating to treatment identification and missing data, were highlighted for these two databases. Although several issues were commonly shared (e.g., only month of event occurrence reported), some database-specific issues were also identified and need to be accounted for. In conclusion, MDV and JMDC present limitations that are relatively typical of RWD sources, though some of them are unique to Japan, such as the identification of event occurrence and the inability to track patients visiting different healthcare settings. Addressing study design and careful result interpretation with respect to the specificities and uniqueness of the Japanese healthcare system is of particular importance. This aspect is especially relevant with respect to the growing global interest of conducting RWD studies in Japan. |
|---|
| 投稿者 | Laurent, Thomas; Simeone, Jason; Kuwatsuru, Ryohei; Hirano, Takahiro; Graham, Sophie; Wakabayashi, Ryozo; Phillips, Robert; Isomura, Tatsuya |
|---|
| 組織名 | Clinical Study Support Inc., 2F Daiei Bldg., 1-11-20 Nishiki, Naka-ku, Nagoya,;460-0003, Japan. thomas_laurent@jp-css.com.;Fifth Floor, Real-World Evidence, Evidera, 500 Totten Pond Road, Waltham, MA,;02451, USA.;Department of Radiology, School of Medicine, Juntendo University, Hongo 2-1-1,;Bunkyo-ku, Tokyo, 113-8421, Japan.;Real-World Evidence And Data Assessment (READS), Graduate School of Medicine,;Juntendo University, Hongo 2-1-1, Bunkyo-ku, Tokyo, 113-8421, Japan.;460-0003, Japan.;Real-World Evidence, Evidera, The Ark, 2nd Floor, 201 Talgarth Road, London, W6;8BJ, UK. |
|---|
