Kenichi Nakamura, Koji Takeda, Akiko M Saito, Miho Kato, Shinya Sato, Satoshi Nakagawa, Yasuyuki Kawamoto, Eiji Oki, Isamu Okamoto, Hiroaki Okamoto, Hiroshi Katayama, Junki Mizusawa, Harumi Kaba, Taro Shibata, Haruhiko Fukuda
OBJECTIVE: large-scale multicentre clinical trials conducted by cooperative groups have generated a lot of evidence to establish better standard treatments. The Clinical Trials Act was enforced on 1 April 2018, in Japan, and it has remarkably increased the operational burden on investigators, but its long-term impact on cancer cooperative groups is unknown. METHODS: a survey was conducted across the nine major cooperative groups that constitute the Japan Cancer Trials Network to assess the impact of Clinical Trials Act on the number of newly initiated trials from fiscal year (from 1 April to 31 March) 2017 to 2022 and that of ongoing trials on 1 April in each year from 2018 to 2023...
March 26, 2024: Japanese Journal of Clinical Oncology