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, analyzed in a statistically adequate manner, and intelligibly presented to ensure a high study quality and 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 organizations.
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.
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 "
Andrew Bottomley, Assistant Director and Head of the Quality of Life Department, SISAQOL-IMI Project Coordinator, European Organisation for Research and Treatment of Cancer (EORTC)
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 organizations 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.
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