• Paul G Kluetz, Daniel J O'Connor, and Katherine Soltys.
• Oncology Center of Excellence, US Food and Drug Administration, Silver Spring, MD, USA. Electronic address: paul.kluetz@fda.hhs.gov.
• Lancet Oncol. 2018 May 1; 19 (5): e267-e274.

AbstractThe clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into the clinical decision-making process is of increasing interest to the international regulatory and health policy community. Disease and treatment-related symptoms and their effect on patient function and health-related quality of life are important outcomes to consider. The identification of methods to scientifically assess, analyse, interpret, and present these clinical outcomes requires sustained international collaboration by multiple stakeholders including patients, clinicians, scientists, and policy makers. Several data sources can be considered to capture the patient experience, including patient-reported outcome (PRO) measures, performance measures, wearable devices, and biosensors, as well as the careful collection and analysis of clinical events and supportive care medications. In this Policy Review, we focus on PRO measures and present the perspectives of three international regulatory scientists to identify areas of common ground regarding opportunities to incorporate rigorous PRO data into the regulatory decision-making process.Copyright © 2018 Elsevier Ltd. All rights reserved.

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