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

Date de signature de la CE 9 Novembre 2020

Date de début 1 Janvier 2021

Date de fin 31 Decembre 2024

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

Livrables

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.

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