HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-world Evidence Studies on Treatment Effects (Japanese Version)： A Good Practices Report of a Joint ISPE/ISPOR Task Force-Reference-Cited by-同舟云学术

HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-world Evidence Studies on Treatment Effects (Japanese Version)： A Good Practices Report of a Joint ISPE/ISPOR Task Force

Published:2023-06-30 Issue:1 Volume:28 Page:17-35
ISSN:1342-0445
Container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku
language:en
Short-container-title:Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku

Author:

FUKASAWA Toshiki¹,IWAGAMI Masao²,HARA Azusa³,NONAKA Takahiro⁴,URUSHIHARA Hisashi³

Affiliation:

1. Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan

2. Department of Health Services Research, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan

3. Division of Drug Development and Regulatory Science, Faculty of Pharmacy, Keio University, Tokyo, Japan

4. Department of Health and Medical Innovation, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan

Publisher

Japanese Society for Pharmacoepidemiology

Subject

General Medicine

Link

https://www.jstage.jst.go.jp/article/jjpe/28/1/28_28.17/_pdf

Reference62 articles.

1. 1) US Food and Drug Administration. Framework for FDA's Real-World Evidence Program. ［https://www.fda.gov/media/120060/download （accessed 2019-1-31）］

2. 2) Sun X, Tan J, Tang L, Guo JJ, Li X. Real world evidence： experience and lessons from China. BMJ 2018； 360： j5262.

3. 3) Government of Canada. Elements of real world data/evidence quality throughout the prescription drug product life cycle. ［https://www.canada.ca/en/services/health/publications/drugs-health-products/real-world-data-evidence-drug-lifecycle-report.html （accessed 2020-5-5）］

4. 4) Ball R, Robb M, Anderson SA, Dal Pan G. The FDA's sentinel initiative--A comprehensive approach to medical product surveillance. Clin Pharmacol Ther 2016； 99： 265-8.

5. 5) Kurz X, Perez-Gutthann S； ENCePP Steering Group. Strengthening standards, transparency, and collaboration to support medicine evaluation： Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance （ENCePP）. Pharmacoepidemiol Drug Saf 2018；27：245-52.

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1. 序文　HARPER の翻訳および関連する本企画について;Japanese Journal of Pharmacoepidemiology/Yakuzai ekigaku;2023-06-30