University of Hertfordshire

Integrating PRO Assessment in Clinical Trials, Routine Clinical Practice and Medicines Development Programmes

Research output: Chapter in Book/Report/Conference proceedingChapter

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Original languageEnglish
Title of host publicationLiving with Chronic Disease: Measuring Important Patient-Reported Outcomes
Place of PublicationSingapore
PublisherAdis
Chapter6
Pages143-165
Number of pages22
ISBN (Electronic)978-981-10-8414-0
ISBN (Print)978-981-10-8413-3
DOIs
Publication statusPublished - 7 Sep 2018

Abstract

It is futile to have the most optimised PRO measure developed if it is going to gather dust on the shelf without any use. Whether a PRO measure can be easily integrated into clinical research or clinical practice may depend on several issues—specific to the PRO measure, factors related to the context of use and the potential users. This chapter is intended to discuss the process, key considerations and pitfalls in the application of PRO measures across the different settings – clinical trials, routine clinical practice, medicines regulatory and HTA processes. This represents Step VIII, the final step, of the roadmap presented in this book. We have included findings from some of our research, first, to illustrate integration of PROs in palliative care and chronic pain clinics, and second, perspectives of industry executives and regulators on PROs. We conclude the chapter, with some recommendations on enhancing the application of PRO assessments across different settings.

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