PCR167 At-Home Versus in-Clinic Patient Reported Outcome Compliance in Oncology Clinical Trials

Abstract

There is increased regulatory emphasis on using patient reported outcomes (PROs) in oncology to provide additional information on clinical benefit beyond traditional survival and tumor response endpoints. Latest recommendations highlight core PROs to consider and the need for more frequent assessments for more accurate quality of life evaluation. To accommodate these recommendations, PRO collection is shifting from the clinic to patients’ homes to allow for more frequent data collection while reducing the burden of travel and site visit time. However, given disease progression characteristics, oncology studies are already at risk for low compliance, and unsupervised at-home PRO collection puts greater responsibility on patients. We aimed to determine the impact of at-home data collection on PRO compliance in oncology studies.