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

Información del proyecto

SISAQOL-IMI

Identificador del acuerdo de subvención: 945052

DOI 10.3030/945052

Fecha de la firma de la CE 9 Noviembre 2020

Fecha de inicio 1 Enero 2021

Fecha de finalización 31 Diciembre 2024

Financiado con arreglo a

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

Coste total € 5 944 754,75

Aportación de la UE € 2 281 840,00

Coordinado por

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Belgium

Resultado final

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

Publicaciones

Peer reviewed articles (2)

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

Autores: 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
Publicado en: Lancet Oncology, 2023, ISSN 1470-2045
Editor: 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.

Autores: 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.
Publicado en: Lancet Oncology, 2023, ISSN 1470-2045
Editor: The Lancet Publishing Group
DOI: 10.1016/s1470-2045(23)00157-2