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

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Living with Chronic Disease: Measuring Important Patient-Reported Outcomes

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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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Authors and Affiliations

  1. Global Evidence & Value Development – R&D, Merck KgaA, Darmstadt, Germany

    Paul Kamudoni

  2. Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand

    Nutjaree Johns

  3. Institute of Medicines Development, Cardiff, UK

    Nutjaree Johns

  4. School of Life & Medical Sciences, University of Hertfordshire, Hatfield, Hertfordshire, UK

    Sam Salek

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  1. Paul Kamudoni
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  2. Nutjaree Johns
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  3. Sam Salek
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Kamudoni, P., Johns, N., Salek, S. (2018). Integrating PRO Assessment in Clinical Trials, Routine Clinical Practice and Medicines Development Programmes. In: Living with Chronic Disease: Measuring Important Patient-Reported Outcomes. Adis, Singapore. https://doi.org/10.1007/978-981-10-8414-0_7

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  • DOI: https://doi.org/10.1007/978-981-10-8414-0_7

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  • Publisher Name: Adis, Singapore

  • Print ISBN: 978-981-10-8413-3

  • Online ISBN: 978-981-10-8414-0

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