project . 2021 - 2024 . On going

SISAQOL-IMI

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

Open Access mandate for Publications and Research DataOpen Access mandate for ... European Commission

Funder: European CommissionProject code: 945052 Call for proposal: H2020-JTI-IMI2-2019-18-two-stage
Funded under: H2020 | IMI2-RIA Overall Budget: 5,944,760 EURFunder Contribution: 2,281,840 EUR
Status: On going
Start Date
01 Jan 2021
End Date
31 Dec 2024
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Description

Measuring and quantifying how a patient feels or functions during treatment is an important endpoint in cancer clinical trials. It is generally accepted that the collection of PRO data in cancer clinical trials allows the inclusion of the patient’s voice in the risk-benefit assessment of therapies. However, no standards exist on how to analyse, interpret or report health-related quality of life (HRQOL) and other patient-reported outcomes (PROs). This initiative wants to pursue efforts in addressing the urgent need for standardization, by setting clear and validated standards that are tailored to and endorsed by all relevant stakeholders. With a strong internatio...

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