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SISAQOL-IMI

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Establishing international standards in the analysis of patient reported outcome...

Establishing international standards in the analysis of patient reported outcomes and health related quality of life data in cancer clinical trials 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 inclusio... see more

31/12/2024

EORTC

6M€

Project Budget: 6M€

Project leader

EUROPEAN ORGANISATION FOR RESEARCH AND TREATM... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

PARTICIPATION DEPralty Sin fecha límite de participación.

Ver 33 Participantes

Financing granted El organismo H2020 notifico la concesión del proyecto The day 2024-12-31

IMI2-2019-18-04: Establishing international standard... Specific Challenge:Numerous efforts have been undertaken to standardise the way HRQOL and PRO data a...

I+D

Cerrada does 5 years

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characteristics of the participant

Este proyecto no cuenta con búsquedas de partenariado abiertas en este momento.

Private Information

No hay información privada compartida para este proyecto. Habla con el coordinador.

33 Participantes

EORTC

489.74K€ | Leader

TUTTI PASTA

221.68K€ | participant

KU Leuven

165.50K€ | participant

ESD EVALUATION SOFTWARE DEV...

103.74K€ | participant

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Project duration: 49 months Date Start: 2020-11-09
End date: 2024-12-31

Project leader

EUROPEAN ORGANISATION FOR RESEARCH AND TREATM... No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Project Budget 6M€

participation deadline Sin fecha límite de participación.

Project 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 international and multi-stakeholder Consortium, the initiative aims at finding consensus on suitable methods to analyse valid PRO objectives in cancer randomized clinical trials (RCTs) and ways to communicate these PRO findings in a standardized way that is understandable to all. To achieve this aim, SISAQOL-IMI will identify valid PRO research objectives and match these with appropriate statistical methods for PRO analysis in cancer RCTs. Translation to the estimands framework will be provided. Furthermore, the possibility of extending these recommendations to single-arm trial designs will be explored. Recommendations on clinically meaningful change for PRO instruments, as well as design considerations and ways for assessing quality of collected PRO data will be developed, and tools and templates for presentation and visualization of PRO findings freely made available. Strong emphasis is put on continuous collaboration with patient advocacy representatives throughout the project. Increased interpretability, adoption and full use of PRO outcomes for all stakeholders is expected by providing consensus-based and validated recommendations and communication tools for PRO data, ultimately resulting in better communication and shared decision making, improved outcomes, treatment satisfaction and care.

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