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International Clinical Trials
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A patient-reported outcome (PRO) is a measurement based on a report that comes from the patient (ie, study subject) about the status of their health condition without amendment or interpretation of the report by a clinician or anyone else. A PRO can be measured by self-report or interview, provided that the interviewer records only the patient’s response. Symptoms or other unobservable concepts known only to the patient (eg, pain severity or nausea) can only be measured by PRO measures. PROs can also assess the patient perspective on functioning or activities that may also be observable by others, such as quality of life, time to pain progression, and time to deterioration of physical symptoms.
In 2016, the American Society of Clinical Oncology (ASCO) reported the FDA indicated that benefits in PROs can be the basis for full drug approval (1). While this is true and PROs are clearly the best way to collect patient data in clinical trials, the American Medical Association points out that other challenges exist that many oncology studies struggle to overcome: small patient numbers, very sick or terminally ill patients, high failure rates, and single-arm studies unique to the development of new therapies in oncology (2). For this reason, careful thought must go into designing and implementing PRO measures in the oncology clinical trial setting (3).
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