The Bar Is High: Evaluating Fit-for-Use Oncology Real-World Data for Regulatory Decision Making

被引：5
|
作者：
Lerro, Catherine C. [1 ]
Bradley, Marie C. [2 ]
Forshee, Richard A. [3 ]
Rivera, Donna R. [1 ]
机构：
[1] US FDA, Oncol Ctr Excellence, Off Commissioner, Silver Spring, MD USA
[2] US FDA, Ctr Drug Evaluat & Res, Off Med Policy, Silver Spring, MD 20993 USA
[3] US FDA, Ctr Biol Evaluat & Res, Silver Spring, MD 20993 USA
来源：
JCO CLINICAL CANCER INFORMATICS | 2024年 / 8卷
关键词：
D O I：
10.1200/CCI.23.00261
中图分类号：
R73 [肿瘤学];
学科分类号：
100214 ;
摘要：
引用
收藏
页数：3
相关论文
共 50 条
  • [1] Statistical Consideration for Fit-for-Use Real-World Data to Support Regulatory Decision Making in Drug Development
    Levenson, Mark
    He, Weili
    Chen, Li
    Dharmarajan, Sai
    Izem, Rima
    Meng, Zhaoling
    Pang, Herbert
    Rockhold, Frank
    [J]. STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2023, 15 (03): : 689 - 696
  • [2] Evaluating the Use of Nonrandomized Real-World Data Analyses for Regulatory Decision Making
    Franklin, Jessica M.
    Glynn, Robert J.
    Martin, David
    Schneeweiss, Sebastian
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2019, 105 (04) : 867 - 877
  • [3] Real-World Data Analytics Fit for Regulatory Decision-Making
    Schneeweiss, Sebastian
    Glynn, Robert J.
    [J]. AMERICAN JOURNAL OF LAW & MEDICINE, 2018, 44 (2-3) : 197 - 216
  • [4] Comparison of two assessments of real-world data and real-world evidence for regulatory decision-making
    Yuan, Lily
    Rahman, Motiur
    Concato, John
    [J]. CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2024, 17 (01):
  • [5] Development of audit readiness considerations of real-world data for use in regulatory decision-making
    Atzinger, Christopher B.
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2023, 32 : 411 - 411
  • [6] Use of real-world evidence for oncology clinical decision making in emerging economies
    Petracci, Fernando
    Ghai, Chirag
    Pangilinan, Andrew
    Suarez, Luis Alberto
    Uehara, Roberto
    Ghosn, Marwan
    [J]. FUTURE ONCOLOGY, 2021, 17 (22) : 2951 - 2960
  • [7] Real-World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe
    Cave, Alison
    Kurz, Xavier
    Arlett, Peter
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2019, 106 (01) : 36 - 39
  • [8] SUITABILITY OF NORDIC REAL-WORLD DATA TO SUPPORT EU REGULATORY DECISION MAKING
    Geale, K.
    Grip, Toresson E.
    Ortsater, G.
    [J]. VALUE IN HEALTH, 2022, 25 (12) : S474 - S475
  • [9] Payer perceptions of the use of real-world evidence in oncology-based decision making
    Brixner, Diana
    Biskupiak, Joseph
    Oderda, Gary
    Burgoyne, Douglas
    Malone, Daniel C.
    Arondekar, Bhakti
    Niyazov, Alexander
    [J]. JOURNAL OF MANAGED CARE & SPECIALTY PHARMACY, 2021, 27 (08): : 1096 - 1105
  • [10] THE USE OF REAL-WORLD DATA IN DECISION MAKING FOR ONCOLOGY: A REVIEW OF RECENT HEALTH TECHNOLOGY APPRAISALS IN THE UNITED KINGDOM
    Koufopoulou, M.
    Wissinger, E.
    Oladapo, T.
    Stewart, F.
    Depalma, S.
    Devani, D.
    Rangi, N. D.
    Fusco, N.
    [J]. VALUE IN HEALTH, 2023, 26 (06) : S262 - S262
12345