TL18: Industry Perspective on Practical Issues of PROs
*Sheryl McCoy, Amgen 


Patient-Reported Outcome (PRO) instruments are valuable to effectively assess the benefit and risk of clinical trial products and are viewed as a complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. With the FDA PRO guidance having outlined new standards for using PRO endpoints in clinical trials, sponsors not only need to make certain that there is adequate and convincing evidence to support the selection and use of a given PRO instrument for the intended purpose but also have to meet the challenges such as collecting quality data, handling missing data, differing analysis and reporting strategies. In this round table, we will discuss and share our experiences with regard to PRO endpoint selection, data collection, techniques for handling varied types of missing data, and analysis methodologies being utilized. The participants can share their experience and discuss practical approaches to maintain regulatory compliance and support labeling claims with a PRO basis.