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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

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.

Field of science

  • /medical and health sciences/clinical medicine/cancer

Call for proposal

H2020-JTI-IMI2-2019-18-two-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action

Coordinator

EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL
Address
Avenue E. Mounier 83
1200 Brussels
Belgium
Activity type
Research Organisations
EU contribution
€ 489 743,75

Participants (32)

KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 165 500
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
UNIVERSITAETSKLINIKUM FREIBURG
Germany
EU contribution
€ 41 500
Address
Hugstetter Strasse 49
79106 Freiburg
Activity type
Higher or Secondary Education Establishments
UNIVERSITEIT GENT
Belgium
EU contribution
€ 156 500
Address
Sint Pietersnieuwstraat 25
9000 Gent
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAT INNSBRUCK
Austria
EU contribution
€ 427 500
Address
Christoph Probst Platz 1
6020 Innsbruck
Activity type
Higher or Secondary Education Establishments
ESD - EVALUATION SOFTWARE DEVELOPMENT GMBH
Austria
EU contribution
€ 0
Address
Valiergasse 62
6020 Innsbruck
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITY OF LEEDS
United Kingdom
EU contribution
€ 98 740
Address
Woodhouse Lane
LS2 9JT Leeds
Activity type
Higher or Secondary Education Establishments
JOHNS HOPKINS UNIVERSITY
United States
EU contribution
€ 0
Address
North Charles Street 3400
21218 Baltimore
Activity type
Higher or Secondary Education Establishments
Queen's University at Kingston
Canada
EU contribution
€ 0
Address
University Avenue 99
K7L 3N6 Kingston
Activity type
Higher or Secondary Education Establishments
REGION HOVEDSTADEN
Denmark
EU contribution
€ 0
Address
Kongens Vaenge 2
3400 Hillerod
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
THE UNIVERSITY OF SYDNEY
Australia
EU contribution
€ 0
Address
Camperdown Campus Arundel St 71/79
2006 Sydney
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS LEIDEN
Netherlands
EU contribution
€ 390 500
Address
Albinusdreef 2
2333 ZA Leiden
Activity type
Higher or Secondary Education Establishments
OSLO UNIVERSITETSSYKEHUS HF
Norway
EU contribution
€ 347 460
Address
Kirkeveien 166 Tarnbygget
0450 Oslo
Activity type
Higher or Secondary Education Establishments
MYELOMA PATIENTS EUROPE AISBL
Belgium
EU contribution
€ 0
Address
Avenue Louise 143 4
1050 Bruxelles
Activity type
Other
KLINICKI BOLNICKI CENTAR RIJEKA
Croatia
EU contribution
€ 62 700
Address
Kresimirova 42
51000 Rijeka
Activity type
Research Organisations
MODUS OUTCOMES SAS
France
EU contribution
€ 0
Address
61 Cours De La Liberte
69003 Lyon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
STICHTING VUMC
Netherlands
EU contribution
€ 0
Address
De Boelelaan 1117
1081 HV Amsterdam
Activity type
Research Organisations
NATIONAL CANCER CENTER
Japan
EU contribution
€ 0
Address
5-1-1 Tsukiji Chuo-ku
104 0045 Tokyo
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
STIFTUNG FUR QUALITAT UND WIRTSCHAFTLICHKEIT IM GESUNDHEITSWESEN
Germany
EU contribution
€ 0
Address
Gutenbergstrasse 13
10587 Berlin
Activity type
Research Organisations
FUNDACION PUBLICA MIGUEL SERVET
Spain
EU contribution
€ 22 940
Address
Calle Irunlarrea 3 Centro Investigacion Biomedica Recinto Complejo Hospitalario De Navarra
31008 Pamplona
Activity type
Research Organisations
UNIVERSITY HEALTH NETWORK
Canada
EU contribution
€ 0
Address
190 Elizabeth Street
M5G2C4 Toronto
Activity type
Research Organisations
EUROPEAN SOCIETY FOR MEDICAL ONCOLOGY
Switzerland
EU contribution
€ 0
Address
Via Ginevra 4
6900 Lugano
Activity type
Other
THE CRITICAL PATH INSTITUTE (C-PATH) NON PROFIT CORPORATION
United States
EU contribution
€ 0
Address
E River Road 1730 200
85718 Tucson Az
Activity type
Other
THE UNIVERSITY OF BIRMINGHAM
United Kingdom
EU contribution
€ 0
Address
Edgbaston
B15 2TT Birmingham
Activity type
Higher or Secondary Education Establishments
ADELPHI VALUES LTD
United Kingdom
EU contribution
€ 0
Address
Bankside 3 90 - 100 Southwark Street
SE1 0SW London
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
STATENS LEGEMIDDELVERK
Norway
EU contribution
€ 0
Address
Grensesvingen 26
0213 Oslo
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
CONSORCIO MAR PARC DE SALUT DE BARCELONA
Spain
EU contribution
€ 0
Address
Paseo Maritim 25-29
08003 Barcelona
Activity type
Research Organisations
PFIZER LIMITED
United Kingdom
EU contribution
€ 0
Address
Ramsgate Road
CT13 9NJ Sandwich
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MERCK KOMMANDITGESELLSCHAFT AUF AKTIEN
Germany
EU contribution
€ 0
Address
Frankfurter Strasse 250
64293 Darmstadt
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BAYER AKTIENGESELLSCHAFT
Germany
EU contribution
€ 0
Address
Kaiser-wilhelm-allee 1
51373 Leverkusen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BOEHRINGER INGELHEIM INTERNATIONALGMBH
Germany
EU contribution
€ 0
Address
Binger Strasse
55218 Ingelheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ABBVIE INC
United States
EU contribution
€ 0
Address
North Waukegan Road 1
60064 North Chicago Il
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
THE EUROPEAN MEDICINES AGENCY
Netherlands
EU contribution
€ 78 756,25
Address
Domenico Scarlattilaan 6
1083 HS Amsterdam
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)