The ICH E9(R1) Estimand Framework in the Context of Real-World Data and Observational Studies

被引:0
|
作者
Husemoen, Lotte [1 ]
Morga, Antonia [2 ]
Remiro-Azocar, Antonio [3 ]
Kleinjung, Frank [4 ]
Rantell, Khadija Rerhou [5 ]
Besseghir, Amel [6 ]
Rosettani, Barbara [7 ]
Allignol, Arthur [8 ]
Vaitsiakhovich, Tatsiana [9 ]
Polavieja, Pepa [1 ]
机构
[1] Novo Nordisk, Bagsvaerd, Denmark
[2] Astellas Pharma Europe Ltd, Addlestone, Surrey, England
[3] Bayer, Leverkusen, Germany
[4] Bayer AG, Leverkusen, Germany
[5] MHRA, London, England
[6] SwissBiosim, Biosimilars, Biopharmaceut, Eysins, Switzerland
[7] Bristol Myers Squibb, New York, NY USA
[8] Daiichi Sankyo Europe GmbH, Munich, Germany
[9] Boehringer Ingelheim GmbH & Co KG, Ingelheim, Germany
关键词
D O I
暂无
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
1229
引用
收藏
页码:553 / 554
页数:2
相关论文
共 50 条
  • [21] Framework for approaching federated causal inference based on real-world observational data sources
    Meurisse, M.
    Schutte, N.
    Van Goethem, N.
    Estupinan-Romero, F.
    Bernal-Delgado, E.
    EUROPEAN JOURNAL OF PUBLIC HEALTH, 2024, 34
  • [22] A METHODOLOGICAL FRAMEWORK TO CONDUCT DATA SOURCES LANDSCAPING FOR REAL-WORLD STUDIES (RWS)
    Dong, Z.
    Chen, S. H.
    Taurel, A. F.
    Toh, K. C.
    Kleinman, N. J.
    VALUE IN HEALTH, 2023, 26 (06) : S292 - S292
  • [23] ICH E14 Q & A (R1) document: perspectives on the updated recommendations on thorough QT studies
    Shah, Rashmi R.
    Morganroth, Joel
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2013, 75 (04) : 959 - 965
  • [24] USING REAL-WORLD DATA TO INFORM SMARTER CLINICAL TRIALS AND PROSPECTIVE OBSERVATIONAL STUDIES
    Mehta, S.
    Mountford, W. K.
    McDonald, M. R.
    Stolper, R.
    Zakar, J.
    Lobeck, F.
    Christian, J. B.
    Lang, K.
    VALUE IN HEALTH, 2017, 20 (05) : A345 - A345
  • [25] Framework for federated causal inference based on real-world observational data sources (BY-COVID)
    Meurisse, M.
    Estupinan-Romero, F.
    Van Goethem, N.
    Gonzalez-Galindo, J.
    Bernal-Delgado, E.
    EUROPEAN JOURNAL OF PUBLIC HEALTH, 2023, 33
  • [26] The Certainty Framework for Assessing Real-World Data in Studies of Medical Product Safety and Effectiveness
    Cocoros, Noelle M.
    Arlett, Peter
    Dreyer, Nancy A.
    Ishiguro, Chieko
    Iyasu, Solomon
    Sturkenboom, Miriam
    Zhou, Wei
    Toh, Sengwee
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2021, 109 (05) : 1189 - 1196
  • [27] Characterization of real-world data sources to support observational studies of biologics, including biosimilars in oncology
    Seals, Ryan M.
    Lockhart, Catherine
    Lin, Nancy
    Seeger, John D.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2021, 30 : 164 - 165
  • [28] Investigating the Provision and Context of Use of Hearing Aid Listening Programs From Real-world Data: Observational Study
    Pasta, Alessandro
    Szatmari, Tiberiu-Ioan
    Christensen, Jeppe Hoy
    Jensen, Kasper Juul
    Pontoppidan, Niels Henrik
    Sun, Kang
    Larsen, Jakob Eg
    JOURNAL OF MEDICAL INTERNET RESEARCH, 2022, 24 (10)
  • [29] A Framework for Extension Studies Using Real-World Data to Examine Long-Term Safety and Effectiveness
    Mehmet Burcu
    Cyntia B. Manzano-Salgado
    Anne M. Butler
    Jennifer B. Christian
    Therapeutic Innovation & Regulatory Science, 2022, 56 : 15 - 22
  • [30] A Framework for Methodological Choice and Evidence Assessment for Studies Using External Comparators from Real-World Data
    Gray, Christen M.
    Grimson, Fiona
    Layton, Deborah
    Pocock, Stuart
    Kim, Joseph
    DRUG SAFETY, 2020, 43 (07) : 623 - 633