Our client had multiple phase 1, 2, and 3 clinical trials in hepatocellular carcinoma, renal cell carcinoma, and lymphoma. They needed an experienced partner to plan, analyze, and create reports for the patient-reported health-related quality-of-life (HRQOL) data collected during the trials to maximize their usefulness for all stakeholders.
Our team needed to manage overlapping timelines for the availability of data while adhering to project deadlines. Additionally, we needed to account for differences in reporting requirements across the trials for both clinical study reports and HTA submissions.
Our approach was to propose a cohesive set of core analyses that could be used as needed across the trials. This allowed for efficiencies in planning and conducting the analyses and reporting the result. Analyses included:
- Descriptive analyses of PRO questionnaire completion rates and score changes over time
- Longitudinal mixed modeling to estimate the average differences in HRQOL scores between treatment groups during follow-up while controlling for baseline scores and other covariates
- Analyses to compare the risk of deterioration in HRQOL between treatment groups and to estimate the median time to deterioration