Setting international standards in analyzing patient-reported outcomes and QOL endpoints
An international multidisciplinary consortium, co-led by the European Organisation for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI), has been convened to generate recommendations to standardize the use, analysis, and interpretation of patient reported outcome (PRO) data in cancer clinical trials.
SISAQOL-IMI (Setting International Standards of Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) will establish guidance on how to use patient-reported outcomes in cancer clinical trials so that they can be used in a methodologically sound way, analysed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and a better comparability of results across clinical trials.
SISAQOL-IMI is a public-private collaborative research project under the Innovative Medicines Initiative (IMI). Forty-one stakeholder groups are involved in the partnership, including researchers from the pharmaceutical industry, academia, non-profit associations, cancer institutes, regulators, and patient advocacy organisations. The project aims to improve the interpretability of cancer clinical trials and thereby (in the long run) also provide a more solid and reliable basis for shared decision making between patients and physicians to improve outcomes, treatment satisfaction, and care treatment decisions in clinical practice.
Andrew Bottomley, Assistant Director and Head of the Quality of Life Department at the EORTC and SISAQOL-IMI project coordinator said,
“Outcomes from this project will help us understand more about the impact of treatment on the lives of patients. We are looking forward to working with our project partners to generate recommendations that will be useful to so many different stakeholders ”
Kathy Oliver, Chair and Co-Director of the International Brain Tumour Alliance also commented,
“The SISAQOL-IMI initiative is a ground-breaking project which will set much-needed international standards for PRO data analysis in cancer clinical trials. We look forward to WECAN’s involvement with this exciting initiative”
Dr Ingolf Griebsch Head of Corporate Market Access Oncology at Boehringer Ingelheim and SISAQOL-IMI project leader said,
“SISAQOL-IMI is a great example of how researchers from academia and industry can truly partner with regulators and patient organisations to develop useful recommendations for interpreting PRO data in the future”
SISAQOL-IMI kicked off at the beginning of January and will run for four years.
Please contact: [email protected]
For more information on IMI projects: https:/
This communication reflects the author’s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No?945052. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
American Society for Clinical Oncology
Clinical Hospital Center Rijeka
Complejo Hospitalario de Navarra
Critical Path Institute
Duke University School of Medicine (to represent ISPOR)
European Medicines Agency
European Organisation for Research and Treatment of Cancer
European Society for Medical Oncology
Evaluation Software Development
Institut Hospital del Mar d’Investigacions Mèdiques
Institute for Quality and Efficiency in Health Care
John Hopkins University (representing PROTEUS and PRO Data Presentation Stakeholder Group)
Medical University of Innsbruck
Medicines and Health Care products agency
Merck Healthcare KGaA
Myeloma Patients Europe (representing WECAN)
National Cancer Center Hospital (representing the Japanese Clinical Oncology Group)
Norwegian Medicines Agency
Oslo University Hospital
Patient Relevant Evidence
Queen’s Cancer Research Institute
The Princess Margaret Cancer Centre/University Health Network
Therapeutic Goods Administration
University of Birmingham (to represent SPIRIT-PRO/CONSORT-PRO)
University of Freiburg (representing STRATOS)
University of Ghent (representing STRATOS)
University of Leeds (representing NCRI)
University of Sydney (representing Australian Clinical Trial Group)
University of Texas (MD Anderson Cancer Center)
US Food and Drug Administration