Application of Real-World Evidence to Support FDA Regulatory Decision Making

被引：0
|
作者：
Vipada Khaowroongrueng [1 ]
Tae-Eun Kim [2 ]
Sang-In Park [3 ]
Kwang-Hee Shin [4 ]
机构：
[1] The Government Pharmaceutical Organization,Research Development and Innovation Department
[2] Konkuk University Medical Center,Department of Clinical Pharmacology
[3] Kangwon National University,Department of Pharmacology, College of Medicine
[4] Kyungpook National University,College of Pharmacy, Research Institute of Pharmaceutical Sciences
[5] Kyungpook National University,Infectious Disease Healthcare
来源：
The AAPS Journal | / 27卷 / 4期
关键词：
FDA; real-world evidence; regulatory decision making;
D O I：
10.1208/s12248-025-01082-1
中图分类号：
学科分类号：
摘要：
引用
收藏
相关论文
共 50 条
  • [31] Using real-world data for supporting regulatory decision making: Comparison of cardiovascular and safety outcomes of an empagliflozin randomized clinical trial versus real-world data
    Jang, Ha Young
    Kim, In-Wha
    Oh, Jung Mi
    FRONTIERS IN PHARMACOLOGY, 2022, 13
  • [32] Integrating Real-World Evidence in the Regulatory Decision-Making Process: A Systematic Analysis of Experiences in the US, EU, and China Using a Logic Model
    Li, Meng
    Chen, Shengqi
    Lai, Yunfeng
    Liang, Zuanji
    Wang, Jiaqi
    Shi, Junnan
    Lin, Haojie
    Yao, Dongning
    Hu, Hao
    Ung, Carolina Oi Lam
    FRONTIERS IN MEDICINE, 2021, 8
  • [33] Multiple Perspectives on the Need for Real-World Evidence to Inform Regulatory and Health Technology Assessment Decision-Making: Scoping Review and Stakeholder Interviews
    Jansen, Marieke S.
    Dekkers, Olaf M.
    le Cessie, Saskia
    Hooft, Lotty
    Gardarsdottir, Helga
    de Boer, Anthonius
    Groenwold, Rolf H. H.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2025, 34 (01)
  • [34] Real-World Evidence in Healthcare Decision Making: Global Trends and Case Studies From Latin America
    Justo, Nahila
    Espinoza, Manuel A.
    Ratto, Barbara
    Nicholson, Martha
    Rosselli, Diego
    Ovcinnikova, Olga
    Marti, Sebastian Garcia
    Ferraz, Marcos B.
    Langsam, Martin
    Drummond, Michael F.
    VALUE IN HEALTH, 2019, 22 (06) : 739 - 749
  • [35] Can we use existing guidance to support the development of robust real-world evidence for health technology assessment/payer decision-making?
    Capkun, Gorana
    Corry, Sorcha
    Dowling, Oonagh
    Kolaei, Fatemeh Asad Zadeh Vosta
    Takyar, Shweta
    Furtado, Claudia
    Jonsson, Pall
    Kleinermans, Diane
    Lambert, Laurie
    Schiel, Anja
    Facey, Karen
    INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE, 2022, 38 (01)
  • [36] Pharmacoepidemiology Research-Real-World Evidence for Decision Making
    Berard, Anick
    FRONTIERS IN PHARMACOLOGY, 2021, 12
  • [37] The Role of Real-World Evidence in Treatment Decision-Making, Regulatory Assessment, and Understanding the Perspectives of People with Type 2 Diabetes: Examples with Gliclazide MR
    Kamlesh Khunti
    Mussa Almalki
    Juliana C. N. Chan
    Aslam Amod
    Diabetes Therapy, 2023, 14 : 1609 - 1625
  • [38] The Role of Real-World Evidence in Treatment Decision-Making, Regulatory Assessment, and Understanding the Perspectives of People with Type 2 Diabetes: Examples with Gliclazide MR
    Khunti, Kamlesh
    Almalki, Mussa
    Chan, Juliana C. N.
    Amod, Aslam
    DIABETES THERAPY, 2023, 14 (10) : 1609 - 1625
  • [39] Making Compassionate Use More Useful: Using real-world data, real-world evidence and digital twins to supplement or supplant randomized controlled trials
    Greenbaum, Dov
    PACIFIC SYMPOSIUM ON BICOMPUTING 2021, 2021, : 38 - 49
  • [40] Leveraging Real-World Evidence in Disease-Management Decision-Making with a Total Cost of Care Estimator
    Thanh-Nghia Nguyen
    Trocio, Jeffrey
    Kowal, Stacey
    Ferrufino, Cheryl P.
    Munakata, Julie
    South, Dell
    AMERICAN HEALTH AND DRUG BENEFITS, 2016, 9 (09) : 475 - 485
12345