Project description
Capturing the patient perspective for development of new cancer therapies
Patient-reported outcomes (PROs) are used in cancer clinical trials to determine the impact of a medical treatment or intervention. As such, PROs and health-related quality of life quantifying how a patient feels or functions during treatment are important endpoints. However, the various ways with which these measures are currently analysed and interpreted make it difficult to compare results across trials. In this context, the EU-funded SISAQOL-IMI project will work to standardise methods to analyse valid PRO objectives and ways to communicate these findings. Specifically, it will identify valid PRO research objectives and match these with appropriate statistical methods for PRO analysis in controlled randomised trials.
Objective
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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Funding Scheme
RIA - Research and Innovation actionCoordinator
1200 Bruxelles / Brussel
Belgium
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Participants (32)
3000 Leuven
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79106 Freiburg
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9000 Gent
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6020 Innsbruck
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6020 Innsbruck
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
LS2 9JT Leeds
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21218 Baltimore
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K7L 3N6 Kingston
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3400 Hillerod
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2006 Sydney
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2333 ZA Leiden
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0450 Oslo
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1050 BRUXELLES
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51000 Rijeka
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69003 Lyon
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1081 HV Amsterdam
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104 0045 Tokyo
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10587 Berlin
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31008 Pamplona
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M5G2C4 Toronto
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6900 Lugano
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85718 TUCSON AZ
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B15 2TT Birmingham
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SE1 0SW London
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0213 Oslo
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08003 Barcelona
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CT13 9NJ Sandwich
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64293 Darmstadt
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51373 Leverkusen
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55218 Ingelheim
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60064 North Chicago Il
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1083 HS Amsterdam
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