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CORDIS - EU research results
CORDIS

Establishing international standards in the analysis of patient reported outcomes and health-related quality of life data in cancer clinical trials

CORDIS provides links to public deliverables and publications of HORIZON projects.

Links to deliverables and publications from FP7 projects, as well as links to some specific result types such as dataset and software, are dynamically retrieved from OpenAIRE .

Deliverables

First data management plan, including data access model (opens in new window)

First data management plan including data access model Measures to ensure compliance with GDPR will be described

Revised data management plan, including data access model (opens in new window)

Revised data management plan including data access model Measures to ensure compliance with GDPR will be described

Publications

Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice. (opens in new window)

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. (opens in new window)

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

The role of the estimand framework in the analysis of patient-reported outcomes in single-arm trials: a case study in oncology (opens in new window)

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

STRengthening Analytical Thinking for Observational Studies (STRATOS): Cooperation in the Setting International Standards in Analyzing Patient Reported Outcomes and Quality of Life Endpoints (SISAQOL-IMI) project

Author(s): Saskia le Cessie, Els Goetghebeur, Cecilie Delphin Amdal, Jammbe Musoro, Madeline Pe , Dries Reynders, Satrajit Roychoudhury, Doranne Thomassen, Willi Sauerbrei
Published in: Biometric Bulletin newsletter, 2024
Publisher: The International Biometric Society

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