Setting International Standards in Analysing Patient-Reported Outcomes
and Quality of Life Endpoints
SISAQOL-IMI (Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials – IMI) is an international multidisciplinary consortium, co-led by the European Organization for Research and Treatment of Cancer (EORTC) and Boehringer Ingelheim (BI). The consortium 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 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 General Assembly 2022 | Introduction
SISAQOL IMI GA
Scientific Work Packages
SISAQOL -IMI GA
HTA perspective on SISAQOL-IMI
SISAQOL -IMI GA
Work Package 4
Work Package 7
SISAQOL- IMI GA
Joint patient involvement
SISAQOL -IMI GA
Regulatory perspective on SISAQOL-IMI
Andrew Bottomley and Ingolf Griebsch
Claire Snyder and Michael Brundage
SISAQOL IMI GA | Scientific Work Packages
SISAQOL -IMI GA | HTA perspective on SISAQOL-IMI
SISAQOL -IMI GA | Work Package 4
SISAQOL-IMI GA | Work Package 7
SISAQOL- IMI GA | Joint patient involvement
SISAQOL -IMI GA | Regulatory perspective on SISAQOL-IMI
SISAQOL IMI | Andrew Bottomley and Ingolf Griebsch
SISAQOL IMI | Claire Snyder and Michael Brundage
SISAQOL IMI | Karen Keating
SISAQOL IMI | Abigirl Machingura
Third SISAQOL-IMI Consensus Meeting
On the 23-24 of May, 2023 the SISAQOL-IMI consortium will gather in Portugal for the third SISAQOL-IMI consensus meeting.
Second SISAQOL-IMI Consensus Meeting
On 16 and 17 March, the SISAQOL-IMI consortium will convene virtually for a second consensus meeting involving all 41 members.
Standardizing the design, analysis, and interpretation of patient-reported outcomes in cancer clinical trials
Patient-reported outcomes, or PROs, are important considerations when new cancer therapies are being investigated, including in benefit and risk assessments. PROs include how patients themselves experience and report their symptoms, as well as other health-related quality of life (HRQOL) issues
This four-year collaborative project will develop a set of standards for the design, analysis, interpretation, and presentation of patient-reported outcome (PRO) data for cancer clinical trials. This project and its generated recommendations will be of critical importance to organisations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), as PRO data presented uniformly across trials and cancers will help support fair and informed decision making. Robust and meaningful PRO data may also lead to improved shared decision-making between patients and their treating physicians. This in turn may lead to improved patient satisfaction, an increased likelihood of adherence to treatment, higher likelihood of treatment success, and a reduction in health-care cost.
The SISAQOL-IMI Consortium
SISAQOL-IMI is a public-private collaborative research project under the Innovative Health Initiative (IHI). 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.