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

Descrizione del progetto

DE EN ES FR IT PL

Acquisire la prospettiva del paziente per sviluppare nuove terapie antitumorali

I risultati riportati dai pazienti sono usati nelle sperimentazioni cliniche sul cancro per determinare l’impatto di un trattamento o intervento medico. In quanto tali, tali risultati e la qualità della vita legata alla salute che quantificano come un paziente si sente durante il trattamento o gli effetti dello stesso sono endpoint importanti. Tuttavia i vari modi in cui queste misure sono attualmente analizzate e interpretate rendono difficile confrontare i risultati tra sperimentazioni. In questo contesto, il progetto SISAQOL-IMI, finanziato dall’UE, lavorerà per standardizzare i metodi di analisi di obiettivi validi relativi ai risultati riportati dai pazienti e i modi di comunicare gli esiti. Nello specifico, individuerà obiettivi di ricerca validi relativi ai risultati riportati dai pazienti e li abbinerà a metodi statistici appropriati per l’analisi di tali risultati in sperimentazioni randomizzate controllate.

Obiettivo

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.

Campo scientifico

Parole chiave

Programma(i)

Argomento(i)

Invito a presentare proposte

H2020-JTI-IMI2-2019-18-two-stage

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Meccanismo di finanziamento

RIA - Research and Innovation action

Coordinatore

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Contribution nette de l'UE
€ 489 743,75
Indirizzo
Avenue E. Mounier 83
1200 Bruxelles / Brussel
Belgio

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Regione
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Tipo di attività
Research Organisations
Collegamenti
Costo totale
€ 1 218 303,75

Partecipanti (32)

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Ultimo aggiornamento: 15 Luglio 2024

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Permalink: https://cordis.europa.eu/project/id/945052/it

European Union, 2024