Real-World Evidence for Neonatal Drug Development: Challenges and Opportunities

被引:2
|
作者
Singh, Kanwaljit [1 ]
Concato, John [2 ,3 ]
Davis, Jonathan M. [4 ,5 ]
机构
[1] Crit Path Inst, Pediat Programs, Tucson, AZ USA
[2] US FDA, Off Med Policy, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[3] Yale Univ, Dept Med, New Haven, CT USA
[4] Tufts Med Ctr, Dept Pediat, 800 Washington St, Boston, MA 02111 USA
[5] Tufts Univ, Tufts Clin & Translat Sci Inst, Boston, MA USA
来源
JOURNAL OF PEDIATRICS | 2024年 / 265卷
关键词
D O I
10.1016/j.jpeds.2023.113806
中图分类号
R72 [儿科学];
学科分类号
100202 ;
摘要
引用
收藏
页数:3
相关论文
共 50 条
  • [31] The role of early-phase trials and real-world evidence in drug development
    Van Spall, Harriette G. C.
    Bastien, Arnaud
    Gersh, Bernard
    Greenberg, Barry
    Mohebi, Reza
    Min, James
    Strauss, Karsten
    Thirstrup, Steffen
    Zannad, Faiez
    NATURE CARDIOVASCULAR RESEARCH, 2024, 3 (02): : 110 - 117
  • [32] Integrating scientific and real-world evidence within and beyond the drug development process
    Epstein, Robert S.
    Sidorov, Jaan
    Lehner, Jean-Pierre
    Salimi, Tehseen
    JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH, 2012, 1 : 9 - 13
  • [33] An update from the US Food and Drug Administration on real-world data and real-world evidence
    Dal Pan, Gerald J.
    ANNALS OF ONCOLOGY, 2022, 33 : S407 - S407
  • [34] Utility of real-world evidence in biosimilar development
    Arani, Ramin B.
    Wang, Jessie
    Pang, Dong
    Sinha, Samriddhi Buxy
    Uttenreuther-Fischer, Martina
    Chow, Shein-Chung
    JOURNAL OF BIOPHARMACEUTICAL STATISTICS, 2024,
  • [35] Advancing evidence-based treatment of infectious diseases in children with real-world data: Opportunities and challenges
    Radtke, Kendra K.
    Butte, Atul J.
    FRONTIERS IN PHARMACOLOGY, 2023, 13
  • [36] Real-world study: from real-world data to real-world evidence
    Wen, Yi
    TRANSLATIONAL BREAST CANCER RESEARCH, 2020, 1
  • [37] Real-world evidence of the herb-drug interactions
    Pan, Hsueh-Yi
    Wu, Li-Wei
    Wang, Pin-Chun
    Chiu, Ping-Hung
    Wang, Meng-Ting
    JOURNAL OF FOOD AND DRUG ANALYSIS, 2022, 30 (03) : 316 - 330
  • [38] Opportunities and challenges in partitioning the graph measure space of real-world networks
    Jozsa, Mate
    Lazar, Alpar S.
    Lazar, Zsolt, I
    JOURNAL OF COMPLEX NETWORKS, 2021, 9 (02)
  • [39] Real-world data: a brief review of the methods, applications, challenges and opportunities
    Fang Liu
    Demosthenes Panagiotakos
    BMC Medical Research Methodology, 22
  • [40] Real-world data: a brief review of the methods, applications, challenges and opportunities
    Liu, Fang
    Demosthenes, Panagiotakos
    BMC MEDICAL RESEARCH METHODOLOGY, 2022, 22 (01)