Demonstrating Health-Related Quality of Life Benefit of an Oncology Product

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HRQOL Data Analysis Pooled Across Multiple Trials

VALUE TO CLIENT

Our approach allowed the client to demonstrate that their product consistently provided a significantly longer time to definitive deterioration in HRQOL over placebo across all the distinct types of tumors. Having this information as part of the product profile helped them support discussions with key market access stakeholders and is valuable for patients and providers when discussing treatment options.

OPPORTUNITY

Our client wanted to understand if their oncology product extended time to deterioration in patient-reported health-related quality of life (HRQOL) in 3 different tumor types using data collected across 4 clinical trials.

CHALLENGE

Individual trials that examined time to first deterioration in HRQOL using only PRO data found no difference between the client’s product and placebo groups.

OUR APPROACH

As side effects typically occur in the first few cycles and can potentially be managed with dose modifications, our approach was to reexamine deterioration in HRQoL using time to definitive deterioration. This deterioration definition accounts for the pattern of early declining HRQOL that may resolve.