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ID 115987
Title Alternative
Promotion of clinical trials before / after CTA
Author
Chuma, Masayuki Tokushima University
Kane, Chikako Tokushima University
Sato, Yasutaka Tokushima University
Niimura, Takahiro Tokushima University
Keywords
Clinical Trials Act
specified clinical trials
questionnaire survey
academic research organization
Content Type
Journal Article
Description
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.
Journal Title
The Journal of Medical Investigation
ISSN
13496867
13431420
NCID
AA11166929
Publisher
Tokushima University Faculty of Medicine
Volume
68
Issue
1-2
Start Page
71
End Page
75
Sort Key
71
Published Date
2021-02
EDB ID
DOI (Published Version)
URL ( Publisher's Version )
FullText File
language
eng
TextVersion
Publisher
departments
University Hospital
Medical Sciences