REAL-WORLD DATA AS EXTERNAL CONTROLS FOR SINGLE-ARM TRIALS: ROLE IN REGULATORY AND HEALTH TECHNOLOGY ASSESSMENTS

被引:0
|
作者
Tomeczkowski, J. [1 ]
Partemio, G. [2 ]
Nijhuis, T. [3 ]
Kubitz, N. [1 ]
Kavanagh, S. [4 ]
机构
[1] Janssen Cilag GmbH, Neuss, Germany
[2] IQVIA Ltd, London, England
[3] IQVIA, Amsterdam, Netherlands
[4] Janssen Pharmaceut NV, Beerse, Belgium
关键词
D O I
暂无
中图分类号
F [经济];
学科分类号
02 ;
摘要
HTA24
引用
收藏
页码:S300 / S301
页数:2
相关论文
共 50 条
  • [41] REAL-WORLD DATA TO INFORM HEALTH TECHNOLOGY ASSESSMENTS IN ENGLAND: A REVIEW OF SUBMISSIONS TO THE NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE SINCE 2018
    Liu, H. H.
    Cottam, W. J.
    Daniju, Y.
    Hosnijeh, F. S.
    Bonsu, A. N.
    Ottley, E. C.
    Glen, F.
    [J]. VALUE IN HEALTH, 2022, 25 (12) : S320 - S320
  • [42] The Expanding Role of Real-World Evidence Trials in Health Care Decision Making
    Klonoff, David C.
    [J]. JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY, 2020, 14 (01): : 174 - 179
  • [43] Real-world data and evidence in health technology assessment: When are they complementary, substitutes, or the only sources of data compared to clinical trials?
    de Pouvourville, Gerard
    Armoiry, Xavier
    Lavorel, Aurelie
    Bilbault, Pascal
    Maugendre, Philippe
    Bensimon, Lionel
    Beziz, Dan
    Blin, Patrick
    Borget, Isabelle
    Bouee, Stephane
    Collignon, Cecile
    Dervaux, Benoit
    Durand-Zaleski, Isabelle
    Julien, Marc
    de Leotoing, Lucie
    Majed, Laureen
    Martelli, Nicolas
    Sejourne, Thomas
    Viprey, Marie
    [J]. THERAPIE, 2023, 78 (01): : 81 - 94
  • [44] The evolving role of data & safety monitoring boards for real-world clinical trials
    Bunning, Bryan J.
    Hedlin, Haley
    Chen, Jonathan H.
    Ciolino, Jody D.
    Ferstad, Johannes Opsahl
    Fox, Emily
    Garcia, Ariadna
    Go, Alan
    Johari, Ramesh
    Lee, Justin
    Maahs, David M.
    Mahaffey, Kenneth W.
    Opsahl-Ong, Krista
    Perez, Marco
    Rochford, Kaylin
    Scheinker, David
    Spratt, Heidi
    Turakhia, Mintu P.
    Desai, Manisha
    [J]. JOURNAL OF CLINICAL AND TRANSLATIONAL SCIENCE, 2023, 7 (01)
  • [45] REAL-WORLD EVIDENCE RECOMMENDATIONS FOR GENE THERAPIES: REGULATORY VERSUS HEALTH TECHNOLOGY ASSESSMENT
    Allen, G.
    Summers, D. M.
    Evans, J.
    [J]. VALUE IN HEALTH, 2020, 23 : S21 - S21
  • [46] Safety of umeclidinium/vilanterol in Chinese patients in a real-world setting:a prospective,multicenter,single-arm,observational study
    牟向东
    [J]. China Medical Abstracts(Internal Medicine)., 2024, 41 (03)
  • [47] HOW ARE SINGLE-ARM TRIALS PERCEIVED IN HEATH TECHNOLOGY ASSESSMENTS FOR CHRONIC LEUKAEMIA ACROSS THE EU5, AUSTRALIA AND CANADA?
    Barwood, C.
    Siddiqui, J.
    Fisher, K.
    Gaugris, S.
    [J]. VALUE IN HEALTH, 2019, 22 : S516 - S516
  • [48] How Is Real-World Data Used in Health Technology Assessments to Inform Reimbursement Decisions for Multiple Sclerosis Drugs? A European Perspective
    Cristea, A.
    Persson, M.
    [J]. VALUE IN HEALTH, 2022, 25 (12) : S151 - S151
  • [49] Detecting deviations from the efficacy and safety results of single-arm trials using real-world data: The case of a CAR-T cell therapy in B-cell lymphoma
    Jakobsen, Lasse Hjort
    Callreus, Torbjorn
    Sessa, Maurizio
    Jerkeman, Mats
    Andersen, Morten
    El-Galaly, Tarec Christoffer
    [J]. PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2021, 30 (04) : 514 - 519
  • [50] Real-world evidence: perspectives on challenges, value, and alignment of regulatory and national health technology assessment data collection requirements
    Sievers, Hannah
    Joos, Angelika
    Hiligsmann, Mickael
    [J]. INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE, 2021, 37 (01)