Gnanasakthy A, Crawford R, Qin S, Bender R, Doward L. Advanced patient-reported outcomes. Presented at the 2022 ISPOR Virtual Short Course Program; June 8, 2022.

This course provides an in-depth discussion of the steps needed to successfully implement PRO measurement within the drug development program to generate data to support patient-centered value messages. Formulation of a successful PRO strategy requires an understanding of PRO instrument selection, psychometric evaluation, data capture, and interpretation in order to negotiate regulatory, reimbursement, and market access drug development hurdles. Judging PRO instrument quality and appropriateness can be challenging. The course will present the key elements to consider at each step in reviewing and selecting PRO measures and determining the need for new instruments. In addition, participants will gain a better understanding of psychometric measurement properties and aspects to consider when interpreting meaningful change. The course will include interactive discussion of PRO success stories and common pitfalls to watch-out for during PRO implementation in clinical trial programs. Participants will gain the knowledge and skills required to take on a more active and confident role in the PRO strategy and implementation process.

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