Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice.
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Author(s):
Liu L, Choi J, Musoro JZ, Sauerbrei W, Amdal CD, Alanya A, Barbachano Y, Cappelleri JC, Falk RS, Fiero MH, Regnault A, Reijneveld JC, Sandin R, Thomassen D, Roychoudhury S, Goetghebeur E, le Cessie S; SISAQOL-IMI Work Package 3
Published in:
Lancet Oncology, 2023, ISSN 1470-2045
Publisher:
The Lancet Publishing Group
DOI:
10.1016/s1470-2045(23)00110-9
Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeholder views, objectives, and procedures.
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Author(s):
Pe M, Alanya A, Falk RS, Amdal CD, Bjordal K, Chang J, Cislo P, Coens C, Dirven L, Speck RM, Fitzgerald K, Galinsky J, Giesinger JM, Holzner B, Le Cessie S, O'Connor D, Oliver K, Pawar V, Quinten C, Schlichting M, Ren J, Roychoudhury S, Taphoorn MJB, Velikova G, Wintner LM, Griebsch I, Bottomley A; SISAQOL-IMI Consortium.
Published in:
Lancet Oncology, 2023, ISSN 1470-2045
Publisher:
The Lancet Publishing Group
DOI:
10.1016/s1470-2045(23)00157-2
SISAQOL-IMI consensus-based guidelines to design, analyse, interpret, and present patient-reported outcomes in cancer clinical trials
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Author(s):
Cecilie D Amdal, Ragnhild S Falk, Ahu Alanya, Michael Schlichting, Satrajit Roychoudhury, Vishal Bhatnagar, Lisa M Wintner, Antoine Regnault, Anders Ingelgård, Corneel Coens, Saskia le Cessie, Bernhard Holzner, Jane Chang, Martin Taphoorn, Paul Cislo, Johannes M Giesinger, Joseph C Cappelleri, Vivek Pawar, Silene ten Seldam, Elektra J Papadopoulos, Melanie J Calvert, Kenth L Joseph, Andrew Bottom
Published in:
The Lancet Oncology, Issue 26, 2025, Page(s) e683-e693, ISSN 1470-2045
Publisher:
The Lancet Publishing Group
DOI:
10.1016/s1470-2045(25)00520-0
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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Author(s):
Doranne Thomassen, Satrajit Roychoudhury, Cecilie Delphin Amdal, Dries Reynders, Jammbe Z. Musoro, Willi Sauerbrei, Els Goetghebeur, Saskia le Cessie, null null, Rajesh Kamalakar, Kavita Sail, Ethan Basch, Jaap Reijneveld, Karen Keating, Yun Su, Ahu Alanya, Gerhard Rumpold, Maxime Sasseville, Jennifer Black, Geert Molenberghs, Khadija Rantell, Michael Schlichting, Antoine Regnault, David Ness, Sil
Published in:
BMC Medical Research Methodology, Issue 24, 2024, ISSN 1471-2288
Publisher:
BioMed Central
DOI:
10.1186/s12874-024-02408-x
Handling missing values in patient-reported outcome data in the presence of intercurrent events
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Author(s):
Doranne Thomassen, Satrajit Roychoudhury, Cecilie Delphin Amdal, Dries Reynders, Jammbe Z. Musoro, Willi Sauerbrei, Els Goetghebeur, Saskia le Cessie, null null, Rajesh Kamalakar, Kavita Sail, Ethan Basch, Jaap Reijneveld, Christoph Gerlinger, Ahu Alanya, Gerhard Rumpold, Maxime Sasseville, Jennifer Black, Geert Molenberghs, Khadija Rantell, Michael Schlichting, Antoine Regnault, David Ness, Silen
Published in:
BMC Medical Research Methodology, Issue 25, 2025, ISSN 1471-2288
Publisher:
BioMed Central
DOI:
10.1186/s12874-025-02510-8
