Japan Society of Clinical Trials and Research ( JPT Supplement )
Vol. 48 Suppl. 2 2020
■ The 11th Annual Meeting "The Power to Change the World and the Future"
SYMPOSIUM 1 Future Clinical Research (Based on GCP Renovation)
1 Data Collection Methods and Designs for Future Clinical Research
T. Miyaji
Jpn Pharmacol Ther 2020; 48(s2): s74-76.
2 A New Era of Clinical Trial: Technology and Virtual Trial
M. Ujihara
Jpn Pharmacol Ther 2020; 48(s2): s77-79.
3 Patient Experience and Technology: Toward Cutting-Edge Clinical Trials
A. Kitamura
Jpn Pharmacol Ther 2020; 48(s2): s80-83.
SYMPOSIUM 2 Competency of a Research Scientist, and Research Team Building
1 Constructing and Managing Research Teams for Promising Clinical Trials Based on a View of One Principal Investigator
M. Suzuki
Jpn Pharmacol Ther 2020; 48(s2): s84-86.
2 Role of the Study Managers in Investigator Initiated Trials Conducted in Accordance with GCP Guidelines
H. Kasai
Jpn Pharmacol Ther 2020; 48(s2): s87-89.
SYMPOSIUM 3 Data Science for the World and the Future：
1 Data Management – Current Situation and Challenges –
T. Miyaji
Jpn Pharmacol Ther 2020; 48(s2): s90-92.
2 Introduction to the Society for Clinical Data Management
R. Rostami
Jpn Pharmacol Ther 2020; 48(s2): s93-95.
3 Assessment of Competencies and Career Pathways for Clinical Data Management
M. Takada, et al
Jpn Pharmacol Ther 2020; 48(s2): s96-99.
4 Future of Clinical Data Management
Y. Shibata
Jpn Pharmacol Ther 2020; 48(s2): s100-102.
5 Somewhat Wild Speculation on the Clinical Research Data Manager of the Future
M.N. Zozus
Jpn Pharmacol Ther 2020; 48(s2): s103-109.
■ REVIEW Clinical Trials and Research in Japan: Progress over the Past Decade
History of Investigator-initiaed Clinical Trails
M. Yamamoto
Jpn Pharmacol Ther 2020; 48(s2): s111-118.
■ CASE REPORTS
Efficacy of Monitoring System Implemented with Limited Resources for Investigator-initiated Clinical Trials
S. Tanaka, et al
Jpn Pharmacol Ther 2020; 48(s2): s119-127.
Training of CRAs Utilizing a Rubric at an ARO
T. Kawakami, et al
Jpn Pharmacol Ther 2020; 48(s2): s128-131.
The Current Situation of Understanding of the Clinical Monitoring under the Clinical Trials Act at Kanazawa University Hospital
T. Funasaka, et al
Jpn Pharmacol Ther 2020; 48(s2): s132-135.
■ ORIGINAL ARTICLES
Perceptions toward Clinical Trials and Access to Information
– Survey for Perceptions to Cancer Clinical Trials –
Y. Shiko, et al
Jpn Pharmacol Ther 2020; 48(s2): s136-143.
A Proposed Process for Implementing Statistical Analyses for Global Clinical Trials Including Japan-specific Analyses and Regulatory Responses for Submissions to PMDA
Y. Asami, et al
Jpn Pharmacol Ther 2020; 48(s2): s144-151.
A Survey of the Impact of the Clinical Trials Act on Medical Device Clinical Research
K. Shimizu, et al
Jpn Pharmacol Ther 2020; 48(s2): s152-163.
■ BRIEF REPORT
Clinical Research Nurse: Best Practices and Educational Methods
C. Kane, et al
Jpn Pharmacol Ther 2020; 48(s2): s164-169.