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Guidelines for time...
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Bonnetain, Franck
(author)
Guidelines for time-to-event end-point definitions in trials for pancreatic cancer : Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)
- Article/chapterEnglish2014
Publisher, publication year, extent ...
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Elsevier BV,2014
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:uu-240761
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-240761URI
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https://doi.org/10.1016/j.ejca.2014.07.011DOI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:ref swepub-contenttype
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Subject category:for swepub-publicationtype
Notes
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Background: Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. Methods: Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). Results: For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. Conclusion: The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.
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Bonsing, Bert
(author)
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Conroy, Thierry
(author)
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Dousseau, Adelaide
(author)
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Glimelius, BengtUppsala universitet,Institutionen för immunologi, genetik och patologi(Swepub:uu)bengglim
(author)
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Haustermans, Karin
(author)
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Lacaine, Francois
(author)
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Van Laethem, Jean Luc
(author)
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Aparicio, Thomas
(author)
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Aust, Daniela
(author)
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Bassi, Claudio
(author)
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Berger, Virginie
(author)
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Chamorey, Emmanuel
(author)
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Chibaudel, Benoist
(author)
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Dahan, Laeticia
(author)
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De Gramont, Aimery
(author)
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Delpero, Jean Robert
(author)
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Dervenis, Christos
(author)
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Ducreux, Michel
(author)
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Gal, Jocelyn
(author)
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Gerber, Erich
(author)
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Ghaneh, Paula
(author)
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Hammel, Pascal
(author)
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Hendlisz, Alain
(author)
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Jooste, Valerie
(author)
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Labianca, Roberto
(author)
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Latouche, Aurelien
(author)
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Lutz, Manfred
(author)
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Macarulla, Teresa
(author)
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Malka, David
(author)
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Mauer, Muriel
(author)
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Mitry, Emmanuel
(author)
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Neoptolemos, John
(author)
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Pessaux, Patrick
(author)
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Sauvanet, Alain
(author)
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Tabernero, Josep
(author)
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Taieb, Julien
(author)
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van Tienhoven, Geertjan
(author)
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Gourgou-Bourgade, Sophie
(author)
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Bellera, Carine
(author)
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Mathoulin-Pelissier, Simone
(author)
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Collette, Laurence
(author)
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Uppsala universitetInstitutionen för immunologi, genetik och patologi
(creator_code:org_t)
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In:European Journal of Cancer: Elsevier BV50:17, s. 2983-29930959-80491879-0852
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Bonnetain, Franc ...
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Bonsing, Bert
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Conroy, Thierry
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Dousseau, Adelai ...
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Glimelius, Bengt
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Haustermans, Kar ...
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Lacaine, Francoi ...
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Van Laethem, Jea ...
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Aparicio, Thomas
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Aust, Daniela
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Bassi, Claudio
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Berger, Virginie
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Chamorey, Emmanu ...
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Chibaudel, Benoi ...
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Dahan, Laeticia
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De Gramont, Aime ...
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Delpero, Jean Ro ...
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Dervenis, Christ ...
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Ducreux, Michel
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Gal, Jocelyn
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Gerber, Erich
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Ghaneh, Paula
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Hammel, Pascal
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Hendlisz, Alain
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Jooste, Valerie
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Labianca, Robert ...
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Latouche, Aureli ...
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Lutz, Manfred
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Macarulla, Teres ...
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Malka, David
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Mauer, Muriel
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Mitry, Emmanuel
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Neoptolemos, Joh ...
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Pessaux, Patrick
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Sauvanet, Alain
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Tabernero, Josep
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Taieb, Julien
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van Tienhoven, G ...
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Gourgou-Bourgade ...
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Mathoulin-Peliss ...
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Uppsala University