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After outlining the factors that drive an expanding imperative to incorporate the patient perspective into the assessment of treatment tolerability and safety, the traditional approach to adverse event reporting is contrasted with a paradigm that seeks to incorporate the patient perspective. The key elements of the PRO-CTCAE measurement system are exhibited, and the research challenges, gaps in knowledge, and the issues that will need to be resolved to fully implement this new approach are examined. The presentation concludes by highlighting (i) NCI efforts to make PRO-CTCAE more widely available to investigators in the extramural community, including academic and industry investigators both in the US U.S. and internationally; (ii) ongoing PRO-CTCAE consortium studies to evaluate and refine both the PRO-CTCAE items and the electronic system for patient-reported AE ascertainment and to scale up for integration into the clinical trial workflow and into existing platforms for electronic data capture and electronic health records; and (iii) envision some of the future directions for PRO-CTCAE, as both a drug development tool and as a potential platform upon which to build improvements in symptom management and care quality for patients participating in cancer clinical trials.

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Dr. Sandra A. Mitchell is a Research Scientist research scientist in the Outcomes Research Branch of the Applied Research Program, Division of Cancer Control and Population Sciences, at the National Cancer Institute. Her work focuses on the development and testing of measures of symptom burden, physical function, and sleep and fatigue in patients with cancer, and the application of these outcomes to evaluate therapeutic response and treatment toxicity in clinical trials. Her methodologic interests include latent variable mixture modeling to characterize underlying heterogeneity, and analysis and interpretation issues of patient-reported outcomes, including health-related quality of life. A board certified Acute Care Nurse Practitioneracute care nurse practitioner, Dr. Mitchell maintains a clinical practice as an Oncology Nurse Practitioner oncology nurse practitioner with the Experimental Transplantation and Immunology Branch, NCI Intramural Program, focusing on long-term survivors of allogeneic hematopoietic stem cell transplantation with Chronic Graft-Versus-Host Disease. Dr. Mitchell serves as the Program Director for the development and testing of PRO-CTCAE, a new measurement system to integrate patient-reporting of symptomatic adverse events into cancer clinical trials.

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