The importance of patient-reported outcomes in clinical trials and strategies for future optimization

Research output: Contribution to journalArticlepeer-review

Colleges, School and Institutes


Patient-reported outcomes (PROs) can be included in clinical trials as primary or secondary endpoints and increasingly recognised by regulators, clinicians and patients as valuable tools to collect patient-centred data. PROs provide unique information on the impact of a medical condition and its treatment from the patient’s perspective, therefore PROs can be included in clinical trials to ensure the impact of a trial intervention is comprehensively assessed. This manuscript first discusses examples of how PRO endpoints have added value to clinical trial interpretation. The second half of this manuscript describes problems with current practices in designing, implementing and reporting PRO studies, and how these problems may be addressed by complying with guidance for protocol development, selecting appropriate PRO measures to match clinically-motivated PRO hypotheses, minimising the rates of avoidable missing PRO data, analysing and interpreting PRO data, and transparently reporting PRO findings.


Original languageEnglish
Pages (from-to)353-367
JournalJournal of Patient-Reported Outcomes
Early online date1 Nov 2018
Publication statusE-pub ahead of print - 1 Nov 2018


  • patient-reported outcomes, quality of life, trial conduct, research practices, Clinical trials as topic