[Comment] Patient-reported outcomes: an essential component of oncology drug development and regulatory review

When evaluating the risks and benefits of a new cancer drug, an understanding of the ways in which a drug affects how a patient feels and functions is crucial. Without such information, clinicians, patients, researchers, and regulators are left with an incomplete picture of the properties of that product; however, this situation is the norm in drug development programmes. Despite rising interest in patient-focused drug development in the past decade,1 most drug developers still do not rigorously and comprehensively collect information directly from patients about symptoms or physical functioning in pivotal trials upon which regulatory approval is based.

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