Abstract

Patient-Reported Outcomes (PROs) data, for example quality of life and symptom burden, are increasingly captured within cancer clinical trials to provide the patient perspective on the physical, functional, psychological and social consequences of treatment and the degree and impact of disease symptoms. This information is important in supporting patients to make more informed treatment decisions at the point of cancer diagnosis and beyond. The utility of such data been recognized by all sectors of the health care community, including patients, clinicians, funders, regulators and policy-makers. Despite this, emerging evidence suggests that PRO information is commonly omitted from protocols, potentially leading to impaired data collection, and PRO results are poorly reported in trial publications, or may not be reported at all. This represents a waste of limited healthcare and research resources, and may restrict the effective use of PRO data to inform clinical decisions made by patients and other stakeholders. This presentation will outline the latest evidence regarding best-practice integration of PROs into cancer clinical trials, with a focus on recent international guidelines including the SPIRIT and CONSORT PRO extensions and the EMA perspective.