山中 寿
Department School of Medicine(Tokyo Women's Medical University Hospital), School of Medicine Position Visiting Professor |
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Article types | Original article |
Language | English |
Peer review | Non peer reviewed |
Title | Using epidemiological registry data to provide background rates as context for adverse events in a rheumatoid arthritis drug development program: a coordinated approach. |
Journal | Formal name:Pharmacoepidemiology and drug safety Abbreviation:Pharmacoepidemiol Drug Saf ISSN code:(1099-1557)1053-8569(Linking) |
Domestic / Foregin | Foregin |
Volume, Issue, Page | 24(11),pp.1121-32 |
Author and coauthor | Nyberg Fredrik, Askling Johan, Berglind Niklas, Franzén Stefan, Ho Meilien, Holmqvist Marie, Horne Laura, Lampl Kathy, Michaud Kaleb, Pappas Dimitrios A, Reed George, Symmons Deborah, Tanaka Eiichi, Tran Trung N, Verstappen Suzanne M M, Wesby-van Swaay Eveline, Yamanaka Hisashi, Greenberg Jeffrey D |
Publication date | 2015/11 |
Summary | Compared with reliance on published data alone, a forward-looking coordinated approach across multiple observational data sources can improve comparability and consistency and better support sensitivity analyses and data interpretation, in contextualizing safety data from clinical trials. This approach may have utility to support safety assessments across diverse diseases and drug development programs and satisfy future regulatory requirements. |
DOI | 10.1002/pds.3854 |
PMID | 26303866 |