Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials - Innovative Medicines Initiative (SISAQOL-IMI): Stakeholder Views, Objectives, and Procedures

Patient-reported outcomes (PROs), such as symptoms, functioning and other health-related quality of life concepts are gaining a more prominent role in the benefit/risk assessment of cancer therapies. However, varying ways of analysing, presenting and interpreting PRO data may lead to erroneous and inconsistent decisions on the part of stakeholders, adversely impacting patient care and outcomes. The Setting International Standards in Analysing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials - Innovative Medicines Initiative (SISAQOL-IMI) Consortium builds on the existing SISAQOL work to establish recommendations on design, analysis, presentation, and interpretation for PRO data in cancer clinical trials. This paper presents an expanded set of topics and international stakeholder views on the need for SISAQOL-IMI, the agreed upon prioritized set of PRO objectives to focus on, and the roadmap to ensure that international consensus recommendations will be achieved.