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.
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Key Dates
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June 3, 2014 - September 7, 2015
Online Registration -
June 3, 2015 - August 15, 2015
Housing -
July 31 - August 17, 2015
Invited Abstract Editing -
August 10, 2015
Short Course materials due from Instructors -
August 26, 2015
Advanced Registration Deadline -
September 7, 2015
Cancellation Deadline -
September 16 - 18, 2015
Marriott Wardman Park, Washington, DC