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ID 115987
タイトル別表記
Promotion of clinical trials before / after CTA
著者
中馬, 真幸 Tokushima University
Kane, Chikako Tokushima University
Sato, Yasutaka Tokushima University
Niimura, Takahiro Tokushima University
キーワード
Clinical Trials Act
specified clinical trials
questionnaire survey
academic research organization
資料タイプ
学術雑誌論文
抄録
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.
掲載誌名
The Journal of Medical Investigation
ISSN
13496867
13431420
cat書誌ID
AA11166929
出版者
Tokushima University Faculty of Medicine
68
1-2
開始ページ
71
終了ページ
75
並び順
71
発行日
2021-02
EDB ID
出版社版DOI
出版社版URL
フルテキストファイル
言語
eng
著者版フラグ
出版社版
部局
病院
医学系