TL41: Patient Reported Outcomes in Oncology
*Laura L Fernandes, FDA 

Keywords: Oncology, bias, open label

Patient reported outcome (PRO) data is routinely collected in clinical trials and is also known as quality of life data. Although a common feature in most therapeutic areas where they are used as the primary endpoint in clinical trial design they are not commonly considered as key endpoints in oncology trials. With the recent thrust for use of PROs in cancer trials, there has been emphasis on implementing this information in the final labelling of the drug. Amongst other topics, we would discuss the common challenges in reporting such data in oncology, ideas on how to overcome these challenges and possible ideas on overcoming bias from data generated from open label trials.