Setting International Standards in
Analysing Patient-Reported Outcomes
and Quality of Life Endpoints

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 aims 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 organizations. These different people may have different ways of collecting and analyzing 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 analyzed, 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.

General definitions

Health related quality of life

Shared decision making

Health technology assessment

Standard of care

Patient reported outcomes

Design definitions

Single arm clinical trials

Randomized clinical trials



Treatment/statistical definitions

Protocol defined treatment

Primary vs secondary outcomes

Treatment discontinuation

Overall survival

Effect & Outcome definitions

Adverse events

Executive summaries

Year one plain language executive summary

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