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

Project Information

SISAQOL-IMI

Grant agreement ID: 945052

DOI 10.3030/945052

EC signature date 9 November 2020

Start date 1 January 2021

End date 31 December 2024

Funded under

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

Total cost € 5 944 754,75

EU contribution € 2 281 840,00

Coordinated by

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Belgium

Deliverables

Documents, reports (3)

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

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

Publications

Peer reviewed articles (2)

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

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.

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