ヤマナカ ヒサシ
  山中 寿
   所属   医学部 医学科(東京女子医科大学病院)
   職種   客員教授
論文種別 原著
言語種別 英語
査読の有無 査読なし
表題 Using epidemiological registry data to provide background rates as context for adverse events in a rheumatoid arthritis drug development program: a coordinated approach.
掲載誌名 正式名:Pharmacoepidemiology and drug safety
略  称:Pharmacoepidemiol Drug Saf
ISSNコード:(1099-1557)1053-8569(Linking)
掲載区分国外
巻・号・頁 24(11),pp.1121-32
著者・共著者 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
発行年月 2015/11
概要 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