Case studies of FDA recently approved product applications using real-world evidence-What are the attributes of studies that support effectiveness determinations?

被引:0
|
作者
Li, Jie [1 ]
Dal Pan, Gerald J. [2 ]
机构
[1] US FDA, Silver Spring, MD USA
[2] FDA, Silver Spring, MD USA
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
325
引用
收藏
页码:145 / 146
页数:2
相关论文
共 50 条
  • [41] REPLICATING PUBLISHED REAL-WORLD EVIDENCE STUDIES USING ELECTRONIC MEDICAL RECORDS FROM COMMUNITY HOSPITALS
    Borda, H.
    Buchanan-Hughes, A.
    VALUE IN HEALTH, 2024, 27 (06) : S383 - S383
  • [42] Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions
    Shirley V. Wang
    Sushama Kattinakere Sreedhara
    Sebastian Schneeweiss
    Nature Communications, 13
  • [43] Reproducibility of real-world evidence studies using clinical practice data to inform regulatory and coverage decisions
    Wang, Shirley, V
    Sreedhara, Sushama Kattinakere
    Schneeweiss, Sebastian
    NATURE COMMUNICATIONS, 2022, 13 (01)
  • [44] A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data
    Gray, Christen M.
    Grimson, Fiona
    Layton, Deborah
    Pocock, Stuart
    Kim, Joseph
    DRUG SAFETY, 2020, 43 (07) : 623 - 633
  • [45] A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data
    Christen M. Gray
    Fiona Grimson
    Deborah Layton
    Stuart Pocock
    Joseph Kim
    Drug Safety, 2020, 43 : 623 - 633
  • [46] Phenotype execution and modeling architecture to support disease surveillance and real-world evidence studies: English sentinel network evaluation
    Jamie, Gavin
    Elson, William
    Kar, Debasish
    Wimalaratna, Rashmi
    Hoang, Uy
    Meza-Torres, Bernardo
    Forbes, Anna
    Hinton, William
    Anand, Sneha
    Ferreira, Filipa
    Byford, Rachel
    Ordonez-Mena, Jose
    Agrawal, Utkarsh
    de Lusignan, Simon
    JAMIA OPEN, 2024, 7 (02)
  • [47] SURF: A Screening Tool (for Sponsors) to Evaluate Whether Using Real-World Data to Support an Effectiveness Claim in an FDA Application Has Regulatory Feasibility
    Campbell, Ulka B.
    Honig, Nicholaas
    Gatto, Nicolle M.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023, 114 (05) : 981 - 993
  • [48] Totality of evidence evaluating the effectiveness of repurposed therapies for COVID-19: What can we learn from real-world studies & randomized controlled trials?
    Qizilbash, Nawab
    Mandema, Jaap
    Montgomery, Hugh E.
    Dron, Louis
    Fu, Shuai
    Russek-Cohen, Estelle
    Bromley, Christina
    Mouksassi, Samer
    Lalonde, Amy
    Ambery, Phil
    McNair, Doug
    Pocock, Stuart
    Zariffa, Nevine
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2022, 31 : 428 - 428
  • [49] Selection Bias in Real-World Data Studies Used to Support Health Technology Assessments: A Case Study in Metastatic Cancer
    Jarada, Tamer N.
    O'Sullivan, Dylan E.
    Brenner, Darren R.
    Cheung, Winson Y.
    Boyne, Devon J.
    CURRENT ONCOLOGY, 2023, 30 (02) : 1945 - 1953
  • [50] Evaluation of Real-World Evidence to Assess Effectiveness Outcomes of Janus Kinase Inhibitors for Rheumatoid Arthritis: A Systematic Review of US Studies
    Gandy, Chandler
    Bazzazzadehgan, Shadi
    Bruera, Sebastian
    Huang, Yinan
    DRUG HEALTHCARE AND PATIENT SAFETY, 2025, 17 : 25 - 49