Questionnaire Survey Regarding Troubles and Concerns Related to Clinical Research Based on the Clinical Trial Act for Clinicians and Academics.

The Clinical Trial Act came into force in 2018 in Japan. A questionnaire survey was conducted with personnel at Kumamoto University Hospital engaged in research and development, to explore their perceptions of troubles and concerns about clinical research related to the Clinical Trial Act. We collected 127 comments about troubles and 149 about concerns. Text mining (co-occurrence network and hierarchical cluster analysis) was used to extract the characteristics or tendencies in these comments. The analysis extracted 18 key terms for troubles and 21 for concerns. Most troubles and concerns had to do with concrete examples of clinical research or protocols and biostatistics information. Our results emphasized the importance of clinical research support organizations, and suggested that appropriate workshops and information covering specific situations are necessary to perform clinical research under the new regime.