3. Utilizing Real World Data in Drug Development ―Expectations from Pharmaceutical Companies―
Author:
Affiliation:
1. Clinical Evaluation Expert Committee, Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association, Japan
2. Pfizer Japan Inc., Japan
3. GlaxoSmithKline K.K., Japan
4. Shionogi & Co.,Ltd., Japan
5. Bristol-Myers Squibb K.K., Japan
Publisher
Japanese Society for Pharmacoepidemiology
Subject
General Medicine
Link
https://www.jstage.jst.go.jp/article/jjpe/24/1/24_24.19/_pdf
Reference28 articles.
1. 1) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Reflection on “GCP Renovation” : Modernization of ICH E8 and Subsequent Renovation of ICH E6. 2017.[https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/GCP_Renovation/ICH_Reflection_paper_GCP_Renovation_Jan_2017_Final.pdf (accessed 2018-11-01)]
2. 8) 21st Century Cures Act, H. R. 34, 114th Congress. 2016. [https://www.congress.gov/bill/114thcongress/house-bill/34/text (accessed 2018-11-01)]
3. 9) U. S. Department of Health and Human Services Food and Drug Administration. Useof Real-World Evidence to Support Regulatory Decision-Making for Medical Devices. [https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm513027.pdf (accessed 2018-11-01)]
4. 10) Innovative Medicines Initiative (IMI) GetREAL project.[http://www.imi-getreal.eu/ (accessed 2018-11-01)]
5. 11) Berger ML, Sox H, Willke RJ, et al. Good practices for real-world data studies of treatment and/or comparative effectiveness:recommendations from the Joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making. Value in Health 2017;20 (8) : 1003-8.
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