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Vol. 47 Suppl. 1 2019

■ REVIEW Future Development of Pharmaceuticals and Medical Devices

Curent Status and Expectations of Diversification of Clinical Trials

H. Ohtsu

Jpn Pharmacol Ther 2019　47(s1) s6-8

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A Background of "Proposal on Assuring the Reliability of Patient Registry Data for Use in Application Dossiers of Pharmaceuticals and Medical Devices"

T. Shibata
Research team for AMED Research on the Regulatory Science of Pharmaceuticals and Medical Devices:
Utilization of real world evidence using patient registry data to support regulatory decision-making.

Jpn Pharmacol Ther 2019　47(s1) s9-12

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Proposal on Assuring the Reliability of Patient Registry Data for Use in Application Dossiers of Pharmaceuticals and Medical Devices.
[January 2019]

AMED Research on the Regulatory Science of Pharmaceuticals and Medical Devices
Title of research and development: Utilization of real world evidence using patient registry data to support regulatory decision-making
[Grant number JP18mk0101068]

Jpn Pharmacol Ther 2019　47(s1) s23-35

■ ORIGINAL ARTICLE

Patients' and Their Family's Information Needs and Reasons for Investigational Medical Care in Oncology:
Consultation Analysis from the Cancer Information and Support Centers

Y. Ogo, et al

Jpn Pharmacol Ther 2019　47(s1) s49-58

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A Survey of Researchers on Clinical Trials Act

H. Kunitoh, et al

Jpn Pharmacol Ther 2019　47(s1) s59-66

■ BRIEF REPORT

Establishment of an Effective Monitoring Support System for ICH-GCP Compliant Trials

A. Saito, et al

Jpn Pharmacol Ther 2019　47(s1) s67-86

■ CASE REPORT

Current Status of Serious Adverse Event Report Contents in Investigator-initiated
Clinical Researches at Kanazawa University Hospital and Actions on Issues

N. Horikawa, et al

Jpn Pharmacol Ther 2019　47(s1) s87-93

■ REVIEW ARTICLE

How to Secure the Quality of the Clinical Trial Efficiently?
Cooperation among Clinical Data Managers

Y. Yamahara, et al

Jpn Pharmacol Ther 2019　47(s1) s94-101