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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.