The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials...
The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology
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Full title
Author / Creator
SISAQOL-IMI Work Package 3 , Thomassen, Doranne , Roychoudhury, Satrajit , Amdal, Cecilie Delphin , Reynders, Dries , Musoro, Jammbe Z. , Sauerbrei, Willi , Goetghebeur, Els , le Cessie, Saskia , Kamalakar, Rajesh , Sail, Kavita , Basch, Ethan , Reijneveld, Jaap , Keating, Karen , Su, Yun , Alanya, Ahu , Rumpold, Gerhard , Sasseville, Maxime , Black, Jennifer , Molenberghs, Geert , Rantell, Khadija , Schlichting, Michael , Regnault, Antoine , Ness, David , ten Seldam, Silene , Reksten, Tove Ragna , Schiel, Anja , Falk, Ragnhild Sorum , Campbell, Alicyn , Cappelleri, Joseph C. , Russell-Smith, Alexander , Calvert, Melanie , Cruz Rivera, Samantha , Aiyegbusi, Olalekan Lee , Liu, Limin , Van Lancker, Kelly , Rutherford, Claudia , Bhatnagar, Vishal , Chen, Ting-Yu , Fiero, Mallorie and Kluetz, Paul
Publisher
England: BioMed Central Ltd
Journal title
Language
English
Formats
Publication information
Publisher
England: BioMed Central Ltd
Subjects
More information
Scope and Contents
Contents
Patient-reported outcomes (PROs) play an increasing role in the evaluation of oncology treatments. At the same time, single-arm trials are commonly included in regulatory approval submissions. Because of the high risk of biases, results from single-arm trials require careful interpretation. This benefits from a clearly defined estimand, or target o...
Alternative Titles
Full title
The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology
Authors, Artists and Contributors
Author / Creator
Thomassen, Doranne
Roychoudhury, Satrajit
Amdal, Cecilie Delphin
Reynders, Dries
Musoro, Jammbe Z.
Sauerbrei, Willi
Goetghebeur, Els
le Cessie, Saskia
Kamalakar, Rajesh
Sail, Kavita
Basch, Ethan
Reijneveld, Jaap
Keating, Karen
Su, Yun
Alanya, Ahu
Rumpold, Gerhard
Sasseville, Maxime
Black, Jennifer
Molenberghs, Geert
Rantell, Khadija
Schlichting, Michael
Regnault, Antoine
Ness, David
ten Seldam, Silene
Reksten, Tove Ragna
Schiel, Anja
Falk, Ragnhild Sorum
Campbell, Alicyn
Cappelleri, Joseph C.
Russell-Smith, Alexander
Calvert, Melanie
Cruz Rivera, Samantha
Aiyegbusi, Olalekan Lee
Liu, Limin
Van Lancker, Kelly
Rutherford, Claudia
Bhatnagar, Vishal
Chen, Ting-Yu
Fiero, Mallorie
Kluetz, Paul
Identifiers
Primary Identifiers
Record Identifier
TN_cdi_doaj_primary_oai_doaj_org_article_0d129c75262d4b7fb9e5a10fb3adf508
Permalink
https://devfeature-collection.sl.nsw.gov.au/record/TN_cdi_doaj_primary_oai_doaj_org_article_0d129c75262d4b7fb9e5a10fb3adf508
Other Identifiers
ISSN
1471-2288
E-ISSN
1471-2288
DOI
10.1186/s12874-024-02408-x