An FDA quality assessment tool for evaluation of real-world evidence observational studies

被引：0
|
作者：
Bradley, Marie C. [1 ]
Hua, Wei [1 ]
Pinheiro, Simone [1 ]
机构：
[1] US FDA, Silver Spring, MD USA
来源：
PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2020年 / 29卷
关键词：
D O I：
暂无
中图分类号：
R1 [预防医学、卫生学];
学科分类号：
1004 ; 120402 ;
摘要：
2472
引用
收藏
页码：418 / 418
页数：1
相关论文
共 50 条
  • [1] Real-World Evidence in the Real World: Beyond the FDA
    Krause, Joan H.
    Saver, Richard S.
    AMERICAN JOURNAL OF LAW & MEDICINE, 2018, 44 (2-3) : 161 - 179
  • [2] Increasing trust in real-world evidence through evaluation of observational data quality
    Blacketer, Clair
    Defalco, Frank J.
    Ryan, Patrick B.
    Rijnbeek, Peter R.
    JOURNAL OF THE AMERICAN MEDICAL INFORMATICS ASSOCIATION, 2021, 28 (10) : 2251 - 2257
  • [3] FDA to Consider Real-World Evidence
    Caruso, Catherine
    CANCER DISCOVERY, 2019, 9 (03) : 310 - 310
  • [4] Use of Structured Template and Reporting Tool for Real-World Evidence for Critical Appraisal of the Quality of Reporting of Real-World Evidence Studies: A Systematic Review
    Khambholja, Kapil
    Gehani, Manish
    VALUE IN HEALTH, 2023, 26 (03) : 427 - 434
  • [5] Real-World Evidence, Public Participation, and the FDA
    Schwartz, Jason L.
    HASTINGS CENTER REPORT, 2017, 47 (06) : 7 - 8
  • [6] Development, content validation, and reliability of the Assessment of Real-World Observational Studies (ArRoWS) critical appraisal tool
    Coles, Briana
    Tyrer, Freya
    Hussein, Humaira
    Dhalwani, Nafeesa
    Khunti, Kamlesh
    ANNALS OF EPIDEMIOLOGY, 2021, 55 : 57 - +
  • [7] Leveraging Real-World Evidence and Observational Studies in Treating Multiple Sclerosis
    Aboseif, Albert
    Roos, Izanne
    Krieger, Stephen
    Kalincik, Tomas
    Hersh, Carrie M.
    NEUROLOGIC CLINICS, 2024, 42 (01) : 203 - 227
  • [8] Real-world observational data factor into FDA's decisions
    Thompson, Cheryl A.
    AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY, 2018, 75 (06) : 338 - 339
  • [9] LANDSCAPE ASSESSMENT OF PROSPECTIVE REAL-WORLD EVIDENCE STUDIES IN EUROPE
    Konig, C.
    Krinke, K.
    Haas, J. S.
    McLeod, K.
    Braun, S.
    VALUE IN HEALTH, 2018, 21 : S195 - S195
  • [10] Estimands in Real-World Evidence Studies
    Chen, Jie
    Scharfstein, Daniel
    Wang, Hongwei
    Yu, Binbing
    Song, Yang
    He, Weili
    Scott, John
    Lin, Xiwu
    Lee, Hana
    STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2024, 16 (02): : 257 - 269
12345