Despite their importance, recent international evidence suggests (i) PRO information is commonly omitted from protocols, leading to impaired data collection; and (ii) PRO results are poorly reported in trial publications, or may not be reported at all. This means that PRO data may be less likely to effectively inform patient and clinician decision-making at the point of diagnosis and beyond, and represents a waste of limited healthcare and research resources.
Research is needed to determine if these findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported.
EPiC phases of research
Phase I - Empirical review of UK cancer trials to review UK cancer trial protocols and their arising publications and model the potential factors influencing completeness of PRO specific protocol content and published results.
Phase 2 - Qualitative study to determine the potential barriers/enablers to optimal PRO protocol content, implementation and reporting.
Phase 3 - Development of an online PRO training resource.