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
  • [1] The Use of Real-world Data to Generate Real-world Evidence to Accelerate Neonatal Drug Development
    Jackson, Shawn S.
    Cravero, Joseph P.
    Sun, Lena
    Davis, Jonathan M.
    JOURNAL OF NEUROSURGICAL ANESTHESIOLOGY, 2025, 37 (01) : 110 - 113
  • [2] Real-world evidence and product development: Opportunities, challenges and risk mitigation
    Poobalan Naidoo
    Célia Bouharati
    Virendra Rambiritch
    Nadina Jose
    Sumanth Karamchand
    Robert Chilton
    Rory Leisegang
    Wiener klinische Wochenschrift, 2021, 133 : 840 - 846
  • [3] Real-world evidence and product development: Opportunities, challenges and risk mitigation
    Naidoo, Poobalan
    Bouharati, Celia
    Rambiritch, Virendra
    Jose, Nadina
    Karamchand, Sumanth
    Chilton, Robert
    Leisegang, Rory
    WIENER KLINISCHE WOCHENSCHRIFT, 2021, 133 (15-16) : 840 - 846
  • [4] Real-world evidence for coverage decisions: opportunities and challenges
    Hampson, Grace
    Towse, Adrian
    Dreitlein, William B.
    Henshall, Chris
    Pearson, Steven D.
    JOURNAL OF COMPARATIVE EFFECTIVENESS RESEARCH, 2018, 7 (12) : 1133 - 1143
  • [5] Roles of real-world evidence in severe asthma treatment: challenges and opportunities
    Lee, Youngsoo
    Lee, Ji-Hyang
    Park, So Young
    Lee, Ji-Ho
    Kim, Joo-Hee
    Kim, Hyun Jung
    Kim, Sang-Heon
    Chung, Kian Fan
    Song, Woo-Jung
    ERJ OPEN RESEARCH, 2023, 9 (02)
  • [6] Challenges and Opportunities for Real-World Evidence in Metastatic Luminal Breast Cancer
    Lueftner, Diana
    Hartkopf, Andreas D.
    Lux, Michael P.
    Overkamp, Friedrich
    Tesch, Hans
    Titzmann, Adriana
    Poschke, Patrik
    Wallwiener, Markus
    Muller, Volkmar
    Beckmann, Matthias W.
    Belleville, Erik
    Janni, Wolfgang
    Fehm, Tanja N.
    Kolberg, Hans-Christian
    Ettl, Johannes
    Wallwiener, Diethelm
    Schneeweiss, Andreas
    Brucker, Sara Y.
    Fasching, Peter A.
    BREAST CARE, 2021, 16 (02) : 108 - 114
  • [7] The Real-World Challenges and Opportunities of Distributed Generation
    Platt, G.
    West, S.
    Moore, T.
    2015 IEEE ENERGY CONVERSION CONGRESS AND EXPOSITION (ECCE), 2015, : 1112 - 1116
  • [8] The "Coming of Age" of Real-World Evidence in Drug Development and Regulation
    Honig, Peter K.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2022, 111 (01) : 11 - 14
  • [9] Use of Real-World Data and Real-World Evidence in Rare Disease Drug Development: A Statistical Perspective
    Chen, Jie
    Gruber, Susan
    Lee, Hana
    Chu, Haitao
    Lee, Shiowjen
    Tian, Haijun
    Wang, Yan
    He, Weili
    Jemielita, Thomas
    Song, Yang
    Tamura, Roy
    Tian, Lu
    Zhao, Yihua
    Chen, Yong
    van Der Laan, Mark
    Nie, Lei
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2025, 117 (04) : 946 - 960
  • [10] Real-World Evidence in Oncology: Opportunities and Limitations
    Di Maio, Massimo
    Perrone, Francesco
    Conte, Pierfranco
    ONCOLOGIST, 2020, 25 (05): : E746 - E752
12345