| Item type |
文献 / Documents(1) |
| 公開日 |
2021-05-25 |
| 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/10.2152/jmi.68.71 |
|
|
言語 |
ja |
|
|
関連名称 |
10.2152/jmi.68.71 |
| 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 |
Academic investigators’ interest in promoting specified clinical trials : Questionnaire survey before and after implementation of the Clinical Trial Act |
|
言語 |
en |
| タイトル別表記 |
|
|
その他のタイトル |
Promotion of clinical trials before / after CTA |
|
言語 |
en |
| 著者 |
中馬, 真幸
武智, 研志
八木, 健太
坂口, 暁
軒原, 浩
カネ, チカコ
サトウ, ヤスタカ
新村, 貴博
合田, 光寛
座間味, 義人
石澤, 啓介
楊河, 宏章
|
| 抄録 |
|
|
内容記述タイプ |
Abstract |
|
内容記述 |
Background : Enforcement of the 2018 Clinical Trials Act (CTA) in Japan resulted in strict and complicated regulations surrounding intervention studies. Few Japan-specific measures have been developed to promote intervention studies in Japan despite concerns about CTA’s negative influence on such studies. Therefore, this study examined the changes in academic investigators’ interest in conducting clinical studies before and after enforcement of the CTA to determine measures to promote specified clinical trials. Methods : We conducted a questionnaire survey with investigators belonging to the Institute of Biomedical Sciences, Tokushima University Graduate School, before and after enforcement of the CTA. Results : Investigators had lesser interest in intervention studies in the post-questionnaire survey (post) group than in the pre-questionnaire survey (pre) group. Their desire for “project management” was significantly higher in the post-group than in the pre-group. Their desire for “support for preparing documents when conducting specified clinical trials” was significantly higher in the group interested in conducting specified clinical trials than that in the not-interested group. Conclusion : We revealed that investigators were highly interested in “project management” and “support for preparing documents when conducting specified clinical trials” after enforcement of the CTA. Measures for these desires may promote specified clinical trials. |
|
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 |
specified clinical trials |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
questionnaire survey |
| キーワード |
|
|
言語 |
en |
|
主題Scheme |
Other |
|
主題 |
academic research organization |
| 書誌情報 |
en : The Journal of Medical Investigation
巻 68,
号 1-2,
p. 71-75,
発行日 2021-02
|
| 収録物ID |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
13496867 |
| 収録物ID |
|
|
収録物識別子タイプ |
ISSN |
|
収録物識別子 |
13431420 |
| 収録物ID |
|
|
収録物識別子タイプ |
NCID |
|
収録物識別子 |
AA11166929 |
| 出版者 |
|
|
出版者 |
Tokushima University Faculty of Medicine |
|
言語 |
en |
| EID |
|
|
識別子 |
375761 |
|
識別子タイプ |
URI |
| 言語 |
|
|
言語 |
eng |
jmi_68_1-2_71.pdf (485 KB)
