Why Capturing PRO Data Matters in Early-Phase Oncology Trials
Capturing patient-reported outcomes (PRO) data is critical in early-phase oncology trials to better understand patient experiences and improve trial outcomes.
Key measures of tolerability in early-phase development include clinician-reported adverse events and indicators such as dose adjustments, hospitalization, and death.
Newer, targeted oncology drugs often show efficacy across a range of doses, making it essential to fully characterize their tolerability profile to determine the optimal dose.
However, a tolerability assessment is incomplete without patient experience data.
By incorporating PRO data, sponsors and CROs gain valuable insights into how patients are tolerating treatments, which can significantly enhance the accuracy of dose-tolerability assessments. This approach not only provides a deeper understanding of the patient experience but also enables more informed decision-making for dose adjustments and overall trial management.
