HOW ARE PATIENT EXPERIENCE DATA REPORTED IN REGULATORY EVALUATION OF MEDICINAL PRODUCTS? A DOCUMENT ANALYSIS OF EUROPEAN PUBLIC ASSESSMENT REPORTS

被引：0
|
作者：
Verbeke, C. [1 ]
Cuppens, J. [1 ]
Huys, I [1 ]
Barbier, L. [1 ]
Janssens, R. [1 ]
机构：
[1] Katholieke Univ Leuven, Dept Pharmaceut & Pharmacol Sci, Leuven, Belgium
来源：
VALUE IN HEALTH | 2023年 / 26卷 / 12期
关键词：
D O I：
暂无
中图分类号：
F [经济];
学科分类号：
02 ;
摘要：
HPR138
引用
收藏
页码：S278 / S278
页数：1
相关论文
共 17 条
  • [1] A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020
    Teixeira, Maria Manuel
    Borges, Fabio Cardoso
    Ferreira, Paula Sousa
    Rocha, Joao
    Sepodes, Bruno
    Torre, Carla
    FRONTIERS IN MEDICINE, 2022, 9
  • [2] The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022
    Michela Meregaglia
    Francesco Malandrini
    Stefania Angelini
    Oriana Ciani
    Applied Health Economics and Health Policy, 2023, 21 : 925 - 935
  • [3] The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022
    Meregaglia, Michela
    Malandrini, Francesco
    Angelini, Stefania
    Ciani, Oriana
    APPLIED HEALTH ECONOMICS AND HEALTH POLICY, 2023, 21 (06) : 925 - 935
  • [4] Comment on: “The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022”
    Sieta T. de Vries
    Noral Huda S. Al-Mugoter
    Irena Petkoska
    Stefan Verweij
    André J. A. Elferink
    Peter G. M. Mol
    Applied Health Economics and Health Policy, 2024, 22 (1) : 123 - 124
  • [5] Precision medicine in regulatory decision making: Biomarkers used for patient selection in European Public Assessment Reports from 2018 to 2020
    Bakker, Elisabeth
    Starokozhko, Viktoriia
    Kraaijvanger, Jet W. M.
    Heerspink, Hiddo J. L.
    Mol, Peter G. M.
    CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2023, 16 (11): : 2394 - 2412
  • [6] THE USE OF PATIENT-REPORTED OUTCOMES FOR NEW DRUGS APPROVAL IN EUROPE: A REVIEW OF EUROPEAN PUBLIC ASSESSMENT REPORTS FROM 2017 TO 2021
    Meregaglia, M.
    Malandrini, F.
    Borroni, C.
    Ciani, O.
    VALUE IN HEALTH, 2022, 25 (12) : S260 - S261
  • [7] How can patient preferences be used and communicated in the regulatory evaluation of medicinal products? Findings and recommendations from IMI PREFER and call to action
    Janssens, Rosanne
    Barbier, Liese
    Muller, Mireille
    Cleemput, Irina
    Stoeckert, Isabelle
    Whichello, Chiara
    Levitan, Bennett
    Hammad, Tarek A.
    Girvalaki, Charis
    Ventura, Juan-Jose
    Bywall, Karin Schoelin
    Pinto, Cathy Anne
    Schoefs, Elise
    Katz, Eva G.
    Kihlbom, Ulrik
    Huys, Isabelle
    FRONTIERS IN PHARMACOLOGY, 2023, 14
  • [8] A full-document analysis of the semantic relation between European Public Assessment Reports and EMA guidelines using a BERT language model
    Bergman, Erik
    Pasmooij, Anna Maria Gerdina
    Mol, Peter G. M.
    Westman, Gabriel
    PLOS ONE, 2023, 18 (12):
  • [9] DATA ON PATIENT-REPORTED OUTCOMES IS NOT A PREREQUISITE FOR ACHIEVING AN ADDITIONAL BENEFIT IN GERMAN EARLY BENEFIT ASSESSMENT OF NEW MEDICINAL PRODUCTS APPROVED FOR DERMATOLOGICAL DISEASES
    Gabriel, M. R.
    Specks, J.
    Duetting, S.
    Damen, D.
    VALUE IN HEALTH, 2023, 26 (12) : S338 - S338
  • [10] Health-related quality of life and other patient-reported outcomes in the European centralized drug regulatory process: A review of guidance documents and performed authorizations of medicinal products 1995 to 2003
    Szende, A
    Leidy, NK
    Revicki, D
    VALUE IN HEALTH, 2005, 8 (05) : 534 - 548
12