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

Informacje na temat projektu

SISAQOL-IMI

Identyfikator umowy o grant: 945052

DOI 10.3030/945052

Data podpisania przez KE 9 Listopada 2020

Data rozpoczęcia 1 Stycznia 2021

Data zakończenia 31 Grudnia 2024

Finansowanie w ramach

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

Koszt całkowity € 5 944 754,75

Wkład UE € 2 281 840,00

Koordynowany przez

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Belgium

Rezultaty

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

Publikacje

Peer reviewed articles (2)

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

Autorzy: 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
Opublikowane w: Lancet Oncology, 2023, ISSN 1470-2045
Wydawca: 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.

Autorzy: 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.
Opublikowane w: Lancet Oncology, 2023, ISSN 1470-2045
Wydawca: The Lancet Publishing Group
DOI: 10.1016/s1470-2045(23)00157-2