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

Informazioni relative al progetto

SISAQOL-IMI

ID dell’accordo di sovvenzione: 945052

DOI

10.3030/945052

Data della firma CE 9 Novembre 2020

Data di avvio 1 Gennaio 2021

Data di completamento 31 Dicembre 2025

Finanziato da

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

Costo totale

€ 5 944 754,75

Contributo UE

€ 2 281 840,00

Coordinato da

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Belgium

CORDIS fornisce collegamenti ai risultati finali pubblici e alle pubblicazioni dei progetti ORIZZONTE.

I link ai risultati e alle pubblicazioni dei progetti del 7° PQ, così come i link ad alcuni tipi di risultati specifici come dataset e software, sono recuperati dinamicamente da .OpenAIRE .

Risultati finali

Documents, reports (4)

Dissemination and exploitation plan of project results; SISAQOL-IMI project website is launched

Dissemination and exploitation plan of project results SISAQOLIMI project website is launched

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

Templates for graphical presentation of PRO findings from cancer clinical trials
Harmonised common glossary

Open Research Data Pilot (2)

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

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

Pubblicazioni

Peer reviewed articles (3)

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

Autori: 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
Pubblicato in: Lancet Oncology, 2023, ISSN 1470-2045
Editore: 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.

Autori: 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.
Pubblicato in: Lancet Oncology, 2023, ISSN 1470-2045
Editore: 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

Autori: 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
Pubblicato in: BMC Medical Research Methodology, Numero 24, 2024, ISSN 1471-2288
Editore: BioMed Central
DOI: 10.1186/s12874-024-02408-x

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

Autori: Saskia le Cessie, Els Goetghebeur, Cecilie Delphin Amdal, Jammbe Musoro, Madeline Pe , Dries Reynders, Satrajit Roychoudhury, Doranne Thomassen, Willi Sauerbrei
Pubblicato in: Biometric Bulletin newsletter, 2024
Editore: The International Biometric Society