Japan Society of Clinical Trials and Research ( JPT Supplement )
Vol. 50 Suppl. 2 2022
■ SYMPOSIUM
The Latest Global Trends of Decentralized Clinical Trial and the Role of Academia for Domestic Implementation in Japan
Yamamoto S.
Jpn Pharmacol Ther 2022; 50(s2): s93-95.
Implementation and Challenges of Fully Decentralized Clinical Trial:
A Study of App-based Intervention Study for Breast Cancer Patients
Mashiko T.
Jpn Pharmacol Ther 2022; 50(s2): s96-97.
History of the Decentralized Clinical Trials and System Challenges to Japan Implementation
Kachi K.
Jpn Pharmacol Ther 2022; 50(s2): s98-101.
■ PROPOSAL
Points to Consider for Operation and Management to Ensure the Reliability of
Registry Data for Use in Application Dossiers of Pharmaceuticals and Medical Devices
AMED Research on Regulatory Science of Pharmaceuticals and Medical Devices
Title of Research Project: Regulatory science research to achieve efficiency
clinical research and development with the utilization of a patient registry
[Grant Number: JP21mk0101154]
Oi H, et al.
Subgroup for “Review of the quality management system and points to consider”
Jpn Pharmacol Ther 2022; 50(s2): s129-153.
■ BRIEF REPORT
Use of Electronic Consent Forms in an Observational Pilot Study of Coronavirus Disease in Japan
Yu J. Imai Y. Nomura A. Yoneda T. Murayama T.
Jpn Pharmacol Ther 2022; 50(s2): s154-165.
■ CASE REPORT
The Questionnaire Survey for Understanding Current Situation of
Specified Clinical Research Based on the Clinical Trials Act at Fukushima Medical University Hospital
Murakami M. Suzuki U. Inoue R. Takahashi T. Noji S.
Watanabe C. Matsumura Y. Sano H. Saito J.
Jpn Pharmacol Ther 2022; 50(s2): s166-171.
■ REVIEW ARTICLES
Cooperation of Industry and Academia to Accelerate Conduct of Clinical Research with Real World Data
—Investigation of the Next Generation Medical Infrastructure Law—
Meeting to Study the Utilization of Real-World Data and the Next Generation Medical Infrastructure Law:
Asai H. Horimatsu T. Kawahara N. Wakabayashi Y. Kuroda Y.
Ashida G. Yoshida Y. Kawahira G. Suzaki Y. Taruno H.
Jpn Pharmacol Ther 2022; 50(s2): s172-178.
Examination of Level-Specific Competencies Required for Academia Monitors
Hamazaki N. Matsushima Y. Inada M. Hirase K. Tai M.
Tamura N. Shimada M. Tanaka Y. Hagimura K. Yano M.
Kawai S. Kondo N. Okamoto Y. Miura T. Yamaguchi T.
Jpn Pharmacol Ther 2022; 50(s2): s179-201.