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Status: Bibliographieeintrag

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Verfasst von:Bellera, Carine A. [VerfasserIn]   i
 Hohenberger, Peter [VerfasserIn]   i
Titel:Guidelines for time-to-event end point definitions in sarcomas and gastrointestinal stromal tumors (GIST) trials
Titelzusatz:results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)
Verf.angabe:C.A. Bellera, N. Penel, M. Ouali, S. Bonvalot, P.G. Casali, O.S. Nielsen, M. Delannes, S. Litière, F. Bonnetain, T.S. Dabakuyo, R.S. Benjamin, J.-Y. Blay, B.N. Bui, F. Collin, T.F. Delaney, F. Duffaud, T. Filleron, M. Fiore, H. Gelderblom, S. George, R. Grimer, P. Grosclaude, A. Gronchi, R. Haas, P. Hohenberger, R. Issels, A. Italiano, V. Jooste, A. Krarup-Hansen, C. Le Péchoux, C. Mussi, O. Oberlin, S. Patel, S. Piperno-Neumann, C. Raut, I. Ray-Coquard, P. Rutkowski, S. Schuetze, S. Sleijfer, E. Stoeckle, M. Van Glabbeke, P. Woll, S. Gourgou-Bourgade and S. Mathoulin-Pélissier
Jahr:2015
Umfang:8 S.
Fussnoten:Gesehen am 07.12.2018 ; Published online 28 July 2014
Titel Quelle:Enthalten in: Annals of oncology
Ort Quelle:Amsterdam [u.a.] : Elsevier, 1990
Jahr Quelle:2015
Band/Heft Quelle:26(2015), 5, Seite 865-872
ISSN Quelle:1569-8041
Abstract:Background: The use of potential surrogate end points for overall survival, such as disease-free survival (DFS) or time-to-treatment failure (TTF) is increasingly common in randomized controlled trials (RCTs) in cancer. However, the definition of time-to-event (TTE) end points is rarely precise and lacks uniformity across trials. End point definition can impact trial results by affecting estimation of treatment effect and statistical power. The DATECAN initiative (Definition for the Assessment of Time-to-event End points in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for RCT in sarcomas and gastrointestinal stromal tumors (GIST). Methods: We first carried out a literature review to identify TTE end points (primary or secondary) reported in publications of RCT. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points. Recommendations were developed through a validated consensus method formalizing the degree of agreement among experts. Results: Recommended guidelines for the definition of TTE end points commonly used in RCT for sarcomas and GIST are provided for adjuvant and metastatic settings, including DFS, TTF, time to progression and others. Conclusion: Use of standardized definitions should facilitate comparison of trials' results, and improve the quality of trial design and reporting. These guidelines could be of particular interest to research scientists involved in the design, conduct, reporting or assessment of RCT such as investigators, statisticians, reviewers, editors or regulatory authorities.
DOI:doi:10.1093/annonc/mdu360
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: http://dx.doi.org/10.1093/annonc/mdu360
 DOI: https://doi.org/10.1093/annonc/mdu360
Datenträger:Online-Ressource
Sprache:eng
K10plus-PPN:1584990902
Verknüpfungen:→ Zeitschrift

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