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

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

  • 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


Latest News

PRESS RELEASE: Generating recommendations for the design, analysis and interpretation of patient- reported outcome (PRO) data for cancer clinical trials: the launch of SISAQOL-IMI

June 6th, 2021|

An international multidisciplinary consortium, co-led by the European Organization 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

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Work Packages

Project Outcomes

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.

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The SISAQOL-IMI Project has received funding from the Innovative Health Initiative 2 joint undertaking under grant agreement No 945052. This Joint
Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.