Believability of real-world evidence (RWE) for informed regulatory decisions

被引:0
|
作者
Leclerc, Jacinthe [1 ]
Brodovicz, Kimberly G. [2 ]
Chang, Stephen [3 ]
Assimon, Magdalene M. [4 ]
Urushihara, Hisashi [5 ]
Girman, Cynthia J. [6 ]
机构
[1] Univ Quebec Trois Rivieres, Trois Rivieres, PQ, Canada
[2] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany
[3] US FDA, Rockville, MD 20857 USA
[4] Univ N Carolina, Sch Med, Chapel Hill, NC 27515 USA
[5] Keio Univ, Tokyo, Japan
[6] CERobs Consulting LLC, Chapel Hill, NC 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
引用
收藏
页码:3 / 3
页数:1
相关论文
共 50 条
  • [31] Targeted Learning: Toward a Future Informed by Real-World Evidence
    Gruber, Susan
    Phillips, Rachael V.
    Lee, Hana
    Ho, Martin
    Concato, John
    van der Laan, Mark J.
    STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2024, 16 (01): : 11 - 25
  • [32] MAKING THE CASE FOR NEGATIVE CONTROL OUTCOME STUDIES IN A REAL-WORLD EVIDENCE (RWE) SETTING
    Pritchard, D.
    Hurwitz, K. Wirth
    Christian, J.
    Brookhart, M. A.
    Rathnayaka, N.
    VALUE IN HEALTH, 2024, 27 (06) : S260 - S260
  • [33] Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
    Roberts, Melissa H.
    Ferguson, Gary T.
    PHARMACOECONOMICS-OPEN, 2021, 5 (01) : 3 - 11
  • [34] Real-World Evidence: Bridging Gaps in Evidence to Guide Payer Decisions
    Melissa H. Roberts
    Gary T. Ferguson
    PharmacoEconomics - Open, 2021, 5 : 3 - 11
  • [35] The use of real-world data/evidence in regulatory submissions
    Song, Fuyu
    Zang, Chenxuan
    Ma, Xinyi
    Hu, Sifan
    Sun, Qiqing
    Chow, Shein-Chung
    Sun, Hongqiang
    CONTEMPORARY CLINICAL TRIALS, 2021, 109
  • [36] Real world evidence (RWE) couture: Attributes of wellfitting regulatory grade evidence for efficacy decision making
    Baptiste, Terrell
    Marchand, Heidi
    Albert, Lisa
    Ntalla, Ioanna
    Peters, Jami
    Li, Hu
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2023, 32 : 320 - 321
  • [37] Modernizing Regulatory Evidence with Trials and Real-World Studies
    Nancy A. Dreyer
    Marni Hall
    Jennifer B. Christian
    Therapeutic Innovation & Regulatory Science, 2020, 54 : 1112 - 1115
  • [38] THE VALUE OF REAL-WORLD EVIDENCE (RWE) IN MELANOMA IN HEALTH TECHNOLOGY ASSESSMENT (HTA) APPRAISALS
    Shah, R.
    Gautam, R.
    Rai, M. K.
    Prasanna, R.
    VALUE IN HEALTH, 2022, 25 (12) : S317 - S317
  • [39] RWE Framework: An Interactive Visual Tool to Support a Real-World Evidence Study Design
    Xia, Andrew D.
    Schaefer, Caroline P.
    Szende, Agota
    Jahn, Elke
    Hirst, Matthew J.
    DRUGS-REAL WORLD OUTCOMES, 2019, 6 (04) : 193 - 203
  • [40] Modernizing Regulatory Evidence with Trials and Real-World Studies
    Dreyer, Nancy A.
    Hall, Marni
    Christian, Jennifer B.
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (05) : 1112 - 1115