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

Informations projet

SISAQOL-IMI

N° de convention de subvention: 945052

DOI

10.3030/945052

Projet clôturé

Date de signature de la CE 9 Novembre 2020

Date de début 1 Janvier 2021

Date de fin 31 Decembre 2025

Financé au titre de

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Coût total

€ 5 944 754,75

Contribution de l’UE

€ 2 281 840,00

Coordonné par

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Belgium

CORDIS fournit des liens vers les livrables publics et les publications des projets HORIZON.

Les liens vers les livrables et les publications des projets du 7e PC, ainsi que les liens vers certains types de résultats spécifiques tels que les jeux de données et les logiciels, sont récupérés dynamiquement sur OpenAIRE .

Livrables

Documents, reports (4)

Dissemination and exploitation plan of project results; SISAQOL-IMI project website is launched
Templates for graphical presentation of PRO findings from cancer clinical trials
Recommendations for dissemination strategies designed to improve patients' understanding of PRO assessment in CCTs

Recommendations for dissemination strategies designed to improve patients’ understanding of PRO assessment in CCTs

Harmonised common glossary

Open Research Data Pilot (2)

Revised data management plan, including data access model

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

First data management plan, including data access model

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

Publications

Peer reviewed articles (5)

Single-arm studies involving patient-reported outcome data in oncology: a literature review on current practice.

Auteurs: 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
Publié dans: Lancet Oncology, 2023, ISSN 1470-2045
Éditeur: 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.

Auteurs: 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.
Publié dans: Lancet Oncology, 2023, ISSN 1470-2045
Éditeur: 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

Auteurs: 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
Publié dans: The Lancet Oncology, Numéro 26, 2025, Page(s) e683-e693, ISSN 1470-2045
Éditeur: 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

Auteurs: 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
Publié dans: BMC Medical Research Methodology, Numéro 24, 2024, ISSN 1471-2288
Éditeur: BioMed Central
DOI: 10.1186/s12874-024-02408-x

Handling missing values in patient-reported outcome data in the presence of intercurrent events

Auteurs: 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
Publié dans: BMC Medical Research Methodology, Numéro 25, 2025, ISSN 1471-2288
Éditeur: BioMed Central
DOI: 10.1186/s12874-025-02510-8

Other (1)

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

Auteurs: Saskia le Cessie, Els Goetghebeur, Cecilie Delphin Amdal, Jammbe Musoro, Madeline Pe , Dries Reynders, Satrajit Roychoudhury, Doranne Thomassen, Willi Sauerbrei
Publié dans: Biometric Bulletin newsletter, 2024
Éditeur: The International Biometric Society