Strength in Collaboration: Advancing PRO Standards in Oncology Trials with SISAQOL-IMI

Thomas M. Menino Convention & Exhibition Center 

Patient-reported outcomes (PROs) are essential for understanding the impact of cancer treatments from the patient's perspective. However, inconsistent methodologies in PRO data collection, analysis, and interpretation have limited their reliability and utility in clinical decision-making. The SISAQOL-IMI (Setting International Standards in Analysing Patient Reported Outcome and Quality of Life Data – Innovative Medicines Initiative) Consortium was established to address these challenges by developing harmonized international recommendations. This multi-stakeholder collaboration brought together 41 organizations, including regulators, HTA bodies, industry, academia, clinicians, statisticians, PRO experts, and patient representatives. Through inclusive working groups, the initiative fostered cross-disciplinary dialogue, enabling statisticians and PRO specialist to communicate complex methodologies in accessible ways and ensuring clinical and patient relevance in analytical decisions. Building on earlier SISAQOL work, the consortium generated recommendations grounded in the estimand framework to guide robust design and analysis strategies. Key recommendations for randomized cancer clinical trials cover handling intercurrent events and missing data, correcting for baseline variability, and improving longitudinal analysis. By aligning statistical and methodological rigor with clinical relevance and patient experience, SISAQOL-IMI exemplifies how international multi-stakeholder collaboration can help improve the interpretability of PROs in cancer trials, ultimately supporting better-informed treatment decisions.

Patient-reported outcomes

SISAQOL-IMI

Estimand