New consortium helps harmonise analysis of patient-reported outcomes and QOL data in cancer clinical trials


A new international multidisciplinary consortium, coordinated by EORTC, aims to provide recommendations to standardize the analysis of health-related quality of life (HRQoL) and other patient-reported outcomes data in cancer randomized clinical trials. Such standards will improve the reproducibility and quality of the data, thereby bringing new insights into patient experience, and providing reliable information to inform product labelling, clinical guidelines and health policy.

“HRQoL and patient-reported outcomes data provide invaluable information to support the evaluation of risks and benefits of cancer therapies,” said Andrew Bottomley, Assistant Director and Head of the Quality of Life department at EORTC. “Such input can support the development of truly patient-centered cancer care systems. However, inconsistencies in how these measures are analysed make it difficult to compare results across trials, and hinder the application of these research findings.”

The Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data (SISAQOL) consortium comprises multi-disciplinary experts, including HRQoL researchers, statisticians, and individuals from various professional societies, advisory and regulatory bodies (EMA, US FDA and HealthCanada), academic societies, pharmaceutical industry, cancer institutes and patient advocacy organizations.

As an initial goal, SISAQOL will focus on standardizing the analysis of HRQoL as measured by patient-reported outcomes, with a view towards broadening its scope to include other ways of measuring HRQoL (e.g. observer or proxy-reports) and other types of patient-reported outcomes (e.g. treatment adherence, satisfaction with care).

“Data generated from HRQoL and other patient-reported outcomes measures are complex and multidimensional, subjecting them to various possible statistical analyses,” Jeff Sloan Professor of Oncology and Biostatistics, Mayo Clinic, and member of the consortium. “Conclusions drawn from these data are intrinsic to the decision-making process for patients, clinicians, industry and regulators, and their rigorous analysis is therefore critical. SISAQOL will bring clear benefits to cancer research, patient/provider decision-making, care delivery, and policymaking by ensuring HRQoL and other patient-reported outcomes can be compared across clinical trials and therefore play a central role in high-quality healthcare delivery.”

The consortium will also conduct a critical literature review to identify common statistical analyses used in cancer randomized controlled trials and examine the possibility of matching statistical methods to appropriate research questions. Finally, for each recommended statistical method, the group aims to develop best practices to ensure a uniform implementation across various statistical assumptions of the underlying data.

Individuals or parties interested in contributing to this consortium, should visit the website for more details.


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