Patient materials

For Patients

SISAQOL-IMI stands for Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life endpoints and is funded under the Innovative Health Initiative, formerly known as the Innovative Medicines Initiative. This 4-year project aimed to generate recommendations on how to standardise the use, analysis, and interpretation of patient-reported outcome (PRO) data in cancer clinical trials. Watch the video below to understand the project.

What are Patient-Reported Outcomes?

PROs are reports that come directly from patients using patient questionnaires. PROs provide important information on how patients feel or function in their daily lives and can be used in a clinical trial setting to measure the impact of a new treatment on a patient’s quality of life. The data collected from PRO questionnaires help decision makers understand more about the benefits and risks of new medicines.

Clinical trials in cancer are run by universities, pharmaceutical companies, and other organisations. These different people may have different ways of collecting and analysing PRO data. This makes it difficult for decision makers to compare the results of trials easily and fairly. To address these problems, SISAQOL-IMI was established. Stakeholders working in SISAQOL-IMI will generate a set of international standards on how PRO data should be collected from patients, then analysed, and presented to people who make decisions in healthcare and to other groups including patients.

Why is this good for patients?

SISAQOL-IMI is good news for patients taking part in cancer clinical trials as the impact that treatment has on their quality of life will be better captured, understood, and presented. This project and its generated standards are also of importance to organizations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), as PRO data presented in the same way across trials and cancers will help support fair and informed decision making.

This in turn may lead to improved patient satisfaction with medicines and treatments, an increased likelihood of adherence to treatment, higher likelihood of treatment success, and a reduction in health‐care cost in the long term. Patients have been involved in the project from the very beginning, and through the Workgroup of European Cancer Patient Advocacy Network (WECAN), will continue to be involved.

Patient checklist

These checklists have been developed based on the SISAQOL-IMI recommendations to support patient advocates and healthcare professionals who are involved in reviewing cancer clinical trial protocols cancer clinical trial results. The checklists consist of lists of key questions that can be used to verify whether the research team or the principal investigator has applied the SISAQOL-IMI recommendations when visually reporting patient-reported outcome (PRO) data from a cancer clinical trial.

Checklist for reviewing PRO in cancer clinical trial protocols

Checklist for reviewing scientific visualizations

Checklist for reviewing plain language visualizations