Project description DEENESFRITPL 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. Show the project objective Hide the project objective 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. Fields of science medical and health sciencesclinical medicineoncology Keywords patient-reported outcomes data analysis Programme(s) H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being Main Programme H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2) Topic(s) IMI2-2019-18-04 - Establishing international standards in the analysis of patient reported outcomes and health-related quality of life data in cancer clinical trials Call for proposal H2020-JTI-IMI2-2019-18-two-stage See other projects for this call Funding Scheme RIA - Research and Innovation action Coordinator EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL Net EU contribution € 489 743,75 Address Avenue e. mounier 83 1200 Bruxelles / brussel Belgium See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 728 560,00 Participants (32) Sort alphabetically Sort by Net EU contribution Expand all Collapse all KATHOLIEKE UNIVERSITEIT LEUVEN Belgium Net EU contribution € 165 500,00 Address Oude markt 13 3000 Leuven See on map Region Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITAETSKLINIKUM FREIBURG Germany Net EU contribution € 41 500,00 Address Hugstetter strasse 49 79106 Freiburg See on map Region Baden-Württemberg Freiburg Freiburg im Breisgau, Stadtkreis Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITEIT GENT Belgium Net EU contribution € 156 500,00 Address Sint pietersnieuwstraat 25 9000 Gent See on map Region Vlaams Gewest Prov. Oost-Vlaanderen Arr. Gent Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 MEDIZINISCHE UNIVERSITAT INNSBRUCK Austria Net EU contribution € 427 500,00 Address Christoph probst platz 1 6020 Innsbruck See on map Region Westösterreich Tirol Innsbruck Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 ESD - EVALUATION SOFTWARE DEVELOPMENT GMBH Austria Net EU contribution € 0,00 Address Valiergasse 62 6020 Innsbruck See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Westösterreich Tirol Innsbruck Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 103 740,00 UNIVERSITY OF LEEDS United Kingdom Net EU contribution € 98 740,00 Address Woodhouse lane LS2 9JT Leeds See on map Region Yorkshire and the Humber West Yorkshire Leeds Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 JOHNS HOPKINS UNIVERSITY United States Net EU contribution € 0,00 Address North charles street 3400 21218 Baltimore See on map Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 20 000,00 Queen's University at Kingston Canada Net EU contribution € 0,00 Address University avenue 99 K7L 3N6 Kingston See on map Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 20 000,00 REGION HOVEDSTADEN Denmark Net EU contribution € 0,00 Address Kongens vaenge 2 3400 Hillerod See on map Region Danmark Hovedstaden Nordsjælland Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 13 200,00 THE UNIVERSITY OF SYDNEY Australia Net EU contribution € 0,00 Address Camperdown campus arundel st 71/79 2006 Sydney See on map Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 56 000,00 ACADEMISCH ZIEKENHUIS LEIDEN Netherlands Net EU contribution € 390 500,00 Address Albinusdreef 2 2333 ZA Leiden See on map Region West-Nederland Zuid-Holland Agglomeratie Leiden en Bollenstreek Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 OSLO UNIVERSITETSSYKEHUS HF Norway Net EU contribution € 347 460,00 Address Kirkeveien 166 tarnbygget 0450 Oslo See on map Region Norge Oslo og Viken Oslo Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 174 258,75 MYELOMA PATIENTS EUROPE AISBL Belgium Net EU contribution € 0,00 Address Avenue louise 143 4 1050 Bruxelles See on map Region Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 262 500,00 KLINICKI BOLNICKI CENTAR RIJEKA Croatia Net EU contribution € 62 700,00 Address Kresimirova 42 51000 Rijeka See on map Region Hrvatska Jadranska Hrvatska Primorsko-goranska županija Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 MODUS OUTCOMES SAS France Net EU contribution € 0,00 Address 61 cours de la liberte 69003 Lyon See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Auvergne-Rhône-Alpes Rhône-Alpes Rhône Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 77 700,00 STICHTING VUMC Netherlands Net EU contribution € 0,00 Address De boelelaan 1117 1081 HV Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Research Organisations Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 16 000,00 NATIONAL CANCER CENTER Japan Net EU contribution € 0,00 Address 5-1-1 tsukiji chuo-ku 104 0045 Tokyo See on map Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 12 200,00 STIFTUNG FUR QUALITAT UND WIRTSCHAFTLICHKEIT IM GESUNDHEITSWESEN Germany Net EU contribution € 0,00 Address Gutenbergstrasse 13 10587 Berlin See on map Region Berlin Berlin Berlin Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 69 000,00 FUNDACION PUBLICA MIGUEL SERVET Spain Net EU contribution € 22 940,00 Address Calle irunlarrea 3 centro investigacion biomedica recinto complejo hospitalario de navarra 31008 Pamplona See on map Region Noreste Comunidad Foral de Navarra Navarra Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00 UNIVERSITY HEALTH NETWORK Canada Net EU contribution € 0,00 Address 190 elizabeth street M5G2C4 Toronto See on map Activity type Research Organisations Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 27 256,00 EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY Switzerland Net EU contribution € 0,00 Address Via ginevra 4 6900 Lugano See on map Region Schweiz/Suisse/Svizzera Ticino Ticino Activity type Other Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 120 000,00 THE CRITICAL PATH INSTITUTE (C-PATH) NON PROFIT CORPORATION United States Net EU contribution € 0,00 Address E river road 1730 200 85718 Tucson az See on map Activity type Other Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 90 000,00 THE UNIVERSITY OF BIRMINGHAM United Kingdom Net EU contribution € 0,00 Address Edgbaston B15 2TT Birmingham See on map Region West Midlands (England) West Midlands Birmingham Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 82 500,00 ADELPHI VALUES LTD United Kingdom Net EU contribution € 0,00 Address Bankside 3 90 - 100 southwark street SE1 0SW London See on map Region London Inner London — East Lewisham and Southwark Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 60 000,00 STATENS LEGEMIDDELVERK Norway Net EU contribution € 0,00 Address Grensesvingen 26 0213 Oslo See on map Region Norge Oslo og Viken Oslo Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 30 000,00 CONSORCIO MAR PARC DE SALUT DE BARCELONA Spain Net EU contribution € 0,00 Address Paseo maritim 25-29 08003 Barcelona See on map Region Este Cataluña Barcelona Activity type Higher or Secondary Education Establishments Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 20 000,00 PFIZER LIMITED United Kingdom Net EU contribution € 0,00 Address Ramsgate road CT13 9NJ Sandwich See on map Region South East (England) Kent East Kent Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 600 000,00 MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN Germany Net EU contribution € 0,00 Address Frankfurter strasse 250 64293 Darmstadt See on map Region Hessen Darmstadt Darmstadt, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 200 000,00 BAYER AKTIENGESELLSCHAFT Germany Net EU contribution € 0,00 Address Kaiser-wilhelm-allee 1 51373 Leverkusen See on map Region Nordrhein-Westfalen Köln Leverkusen, Kreisfreie Stadt Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 200 000,00 BOEHRINGER INGELHEIM INTERNATIONALGMBH Germany Net EU contribution € 0,00 Address Binger strasse 55218 Ingelheim See on map Region Rheinland-Pfalz Rheinhessen-Pfalz Mainz-Bingen Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 480 000,00 ABBVIE INC United States Net EU contribution € 0,00 Address North waukegan road 1 60064 North chicago il See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 200 000,00 THE EUROPEAN MEDICINES AGENCY Netherlands Net EU contribution € 78 756,25 Address Domenico scarlattilaan 6 1083 HS Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments) Links Contact the organisation Opens in new window Website Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Other funding € 0,00