A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?

被引:0
|
作者
M. Mitroiu
K. Oude Rengerink
S. Teerenstra
F. Pétavy
K. C. B. Roes
机构
[1] College ter Beoordeling van Geneesmiddelen,Methodology Working Group
[2] University of Utrecht,Department of Biostatistics and Research Support, Clinical Trial Methodology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht
[3] Radboud University Medical Center,Department for Health Evidence, Section Biostatistics, Radboud Institute for Health Sciences
[4] European Medicines Agency,Biostatistics and Methodology Support Office
来源
Trials | / 21卷
关键词
Estimand; Intention-to-treat; Per protocol; Intercurrent event; Post-randomisation event; Study withdrawal; Treatment compliance; Treatment adherence; Treatment discontinuation; Missing data;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
相关论文
共 50 条
  • [1] A narrative review of estimands in drug development and regulatory evaluation: old wine in new barrels?
    Mitroiu, M.
    Oude Rengerink, K.
    Teerenstra, S.
    Petavy, F.
    Roes, K. C. B.
    [J]. TRIALS, 2020, 21 (01)
  • [2] New wine from old barrels
    John A. Gerlt
    [J]. Nature Structural Biology, 2000, 7 : 171 - 173
  • [3] New wine from old barrels
    Gerlt, JA
    [J]. NATURE STRUCTURAL BIOLOGY, 2000, 7 (03) : 171 - 173
  • [4] New concepts in peritoneal dialysis: New wine in old barrels?
    Van Biesen, W
    Veys, N
    Vanholder, R
    Lameire, N
    [J]. ARTIFICIAL ORGANS, 2003, 27 (05) : 398 - 405
  • [5] Forensic emergency medicine: old wine in new barrels
    De Leeuw, Marc
    Jacobs, Werner
    [J]. EUROPEAN JOURNAL OF EMERGENCY MEDICINE, 2010, 17 (04) : 186 - 191
  • [6] Reliability in Psychiatric Diagnosis with the DSM: Old Wine in New Barrels
    Vanheule, Stijn
    Desmet, Mattias
    Meganck, Reitske
    Inslegers, Ruth
    Willemsen, Jochem
    De Schryver, Maarten
    Devisch, Ignaas
    [J]. PSYCHOTHERAPY AND PSYCHOSOMATICS, 2014, 83 (05) : 313 - 314
  • [7] Financialization Historically Contemplated: Putting Old Wine in New Barrels
    Tsaliki, Persefoni
    Tsoulfidis, Lefteris
    [J]. WORLD REVIEW OF POLITICAL ECONOMY, 2023, 14 (03) : 328 - 356
  • [8] New Wine in Old Barrels: Medical Negligence and Reasonable Care
    Stewart, Angus
    [J]. EDINBURGH LAW REVIEW, 2007, 11 (02) : 251 - 253
  • [9] The Emergence of the Old Drug Captagon as a New Illicit Drug: A Narrative Review
    Pergolizzi Jr, Joseph
    Lequang, Jo Ann K.
    Vortsman, Eugene
    Magnusson, Peter
    EL-Tallawy, Salah N.
    Wagner, Morgan
    Salah, Rania
    Varrassi, Giustino
    [J]. CUREUS JOURNAL OF MEDICAL SCIENCE, 2024, 16 (02)
  • [10] Drug Development Against Sleeping Sickness: Old Wine in New Bottles?
    Stein, J.
    Mogk, S.
    Mudogo, C. N.
    Sommer, B. P.
    Scholze, M.
    Meiwes, A.
    Huber, M.
    Gray, A.
    Duszenko, M.
    [J]. CURRENT MEDICINAL CHEMISTRY, 2014, 21 (15) : 1713 - 1727