| Item type |
文献 / Documents(1) |
| 公開日 |
2022-08-23 |
| アクセス権 |
|
|
アクセス権 |
open access |
| 資源タイプ |
|
|
資源タイプ識別子 |
http://purl.org/coar/resource_type/c_6501 |
|
資源タイプ |
journal article |
| 出版社版DOI |
|
|
|
識別子タイプ |
DOI |
|
|
関連識別子 |
https://doi.org/10.1248/bpb.b21-00753 |
|
|
言語 |
ja |
|
|
関連名称 |
10.1248/bpb.b21-00753 |
| 出版タイプ |
|
|
出版タイプ |
VoR |
|
出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
| タイトル |
|
|
タイトル |
Trends in Investigator-Initiated Clinical Studies at a University Hospital after Enforcement of the 2018 Clinical Trials Act in Japan |
|
言語 |
en |
| 著者 |
サトウ, ヤスタカ
坂口, 暁
武智, 研志
中馬, 真幸
八木, 健太
加根, 千賀子
合田, 光寛
濱野, 裕章
アオエ, ユキ
軒原, 浩
久保, 宜明
橋本, 一郎
楊河, 宏章
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
In April 2018, the Clinical Trials Act pertaining to investigator-initiated clinical trials was passed in Japan. The purpose of this study was to investigate activity in investigator-initiated clinical studies before and after enforcement of the new Clinical Trials Act. This was done by analysing the records of the Ethics Committee of Tokushima University Hospital, which reviews studies based on the Japanese government’s Ethical Guidelines for Medical and Health Research Involving Human Subjects prior to the Clinical Trials Act, and records of the Certified Review Board established at Tokushima University under the Clinical Trials Act in 2018. The number of new applications to these two review boards during fiscal years 2015–2017 (pre-Act) and fiscal years 2018 and 2019 (post-Act) were used as an indicator of activity in investigator-initiated clinical studies. The number of new applications to the Ethics Committee was 303, 261, 316, 303, and 249 in 2015, 2016, 2017, 2018, and 2019, respectively. The data show that the total number of new interventional studies decreased from 50.3 in average in 2015–2017 (pre-Act) to 42 in 2018 and 40 in 2019 (post-Act), respectively. These results suggest that fewer interventional studies were started following enforcement of the new Clinical Trials Act. To confirm this trend and identify contributing factors, further studies are required. In addition, possible way, such as broader contribution of clinical research coordinators, to promote clinical studies in the new Clinical Trials Act era should be examined. |
|
言語 |
en |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Clinical Trials Act |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
clinical research |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
investigator |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
trend |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
Japan |
| 書誌情報 |
en : Biological and Pharmaceutical Bulletin
巻 45,
号 3,
p. 374-377,
発行日 2022-03-01
|
| 収録物ID |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
13475215 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA11696048 |
| 出版者 |
|
|
出版者 |
The Pharmaceutical Society of Japan |
|
言語 |
en |
| EID |
|
|
識別子 |
390277 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
bpb_45_3_374.pdf (301 KB)
