Keywords: oncology, patient-reported outcomes, PRO, PRO implementation, PRO data interpretation
This presentation describes opportunities and challenges in relation to patient-reported outcome (PRO) assessments in oncology clinical trials. The emphasis is on generating PRO evidence that are intended to support regulatory review and labeling considerations. The talk will address concepts of interest, PRO instrument selection, study design, PRO implementation, statistical analyses and data interpretation. I will illustrate the key considerations in PRO measurement strategy development and implementation in oncology using a case study. Practical recommendations will be enumerated to elicit further discussions and for guidance in clinical trials.