2024 年 41 巻 3 号 p. 411-414
As a pioneer of investigator–initiated clinical trials in Japan, Nagoya University started a multi–institutional Phase III study (JASMITT trial) to evaluate the efficacy and safety of leuprorelin acetate in the patients with Spinal and Bulbar Muscular Atrophy (SBMA) in 2006. The JASMITT trial is a translational study based on basic research findings on animal models of SBMA. In investigator–initiated new drug developments, academic researchers often need help to prepare a complete clinical data package. Experience with PMDA may lead to better preparation of regulatory filings. The author joined the New Drug Review 2 of the Pharmaceutical and Medical Device Agency (PMDA) in April 2013, during the clinical development of leuprorelin acetate, and learned the actual operations of consultation and new drug reviews. After that, leuprorelin acetate got approval based on the investigator–initiated clinical trials in 2017.
In April 2021, the Department of Clinical Research Education (CRE) opened at the Nagoya University Graduate School of Medicine to promote clinical researches at Nagoya University. The two essential missions of CRE are “clinical research education” and “clinical research support”. CRE could be the only department to comprehensively deepen understanding and practice from observational researches to clinical trials.
