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


Start Date
End Date
IMI2 - Call 18
Grant agreement number

Type of Action: 
RIA (Research and Innovation Action)

IMI Funding
2 281 840
EFPIA in kind
2 935 000
727 915
Total Cost
5 944 755


In drug development, it is important to find out how treatments affect how patients feel and function in their daily lives. This information is also essential when weighing up the benefits and risks of a medicine. In practice, it is rather difficult to obtain this information and communicate it clearly and simply.

The aim of SISAQOL-IMI is to develop recommendations on how to analyse and interpret data on health-related quality of life (HRQOL) and patient reported outcomes (PROs) in cancer clinical trials.

To do this, the project will seek to achieve consensus internationally and across stakeholder groups on the optimal use of PROs in cancer clinical trials, and gain clarity on the research objectives for the use of PROs in trials, including the definition of ‘clinically meaningful change’.

The project also aims to improve the statistical analysis of PROs in cancer clinical trials, and standardise the way findings are reported, presented and visualised. The standards should be endorsed by all relevant stakeholders.

Furthermore, the project plans to develop educational tools based on the standards; these tools will hopefully help to improve patients’ understanding and empower shared decision making.

Ultimately, the tools and resources developed by SISAQOL-IMI should ensure that cancer clinical trials accurately capture how patients feel or function during treatment. This in turn will aid in decision making for regulators, health technology assessment bodies, and, crucially, improve patient satisfaction. The findings may also be applicable to clinical trials in other disease areas.

Participants Show participants on map

EFPIA companies
  • Abbvie Inc, North Chicago, Illinois, United States
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • Merck Kommanditgesellschaft Auf Aktien, Darmstadt, Germany
  • Pfizer Limited, Sandwich, Kent , United Kingdom
Universities, research organisations, public bodies, non-profit groups
  • Academisch Ziekenhuis Leiden, Leiden, Netherlands
  • Consorcio Mar Parc De Salut De Barcelona, Barcelona, Spain
  • European Organisation For Research And Treatment Of Cancer Aisbl, Brussels, Belgium
  • European Society For Medical Oncology, Viganello-Lugano, Switzerland
  • Fundacion Publica Miguel Servet, Pamplona, Spain
  • Johns Hopkins University, Baltimore, United States
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • Klinicki Bolnicki Centar Rijeka, Rijeka, Croatia
  • Medizinische Universitat Innsbruck, Innsbruck, Austria
  • National Cancer Center, Tokyo, Japan
  • Oslo Universitetssykehus Hf, Oslo, Norway
  • Queen's University at Kingston, Kingston, Canada
  • Region Hovedstaden, Hilleroed, Denmark
  • Statens Legemiddelverk, Oslo, Norway
  • Stichting Vumc, Amsterdam, Netherlands
  • Stiftung Fur Qualitat Und Wirtschaftlichkeit Im Gesundheitswesen, Berlin, Germany
  • The Critical Path Institute (C-Path) Non Profit Corporation, Tucson Az, United States
  • The European Medicines Agency, Canary Wharf, London, United Kingdom
  • The University Of Birmingham, Birmingham, United Kingdom
  • The University Of Sydney, Sydney, Australia
  • Universitaetsklinikum Freiburg, Freiburg, Germany
  • Universiteit Gent, Gent, Belgium
  • University Health Network, Toronto, Canada
  • University Of Leeds, Leeds, United Kingdom
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Esd - Evaluation Software Development GMBH, Innsbruck, Austria
  • Modus Outcomes SAS, Lyon, France
Patient organisations
  • Myeloma Patients Europe Aisbl, Charleroi, Belgium
Non EFPIA companies
  • Adelphi Values LTD, London, United Kingdom
Project coordinator
Andrew Bottomley
European Organisation For Research And Treatment Of Cancer Aisbl