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The standard lexicon for reporting adverse events in National Cancer Institute sponsored clinical trials is the Common Terminology Criteria for Adverse Events (CTCAE). Currently, adverse events are reported by clinicians, yet evidence suggests that compared to patient-report, clinicians may underestimate symptom severity and onset. The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a new patient-reported outcome measurement system that elicits the frequency, severity and interference of 78 treatment toxicities that can be reported from the patient perspective. This presentation offers an overview of the PRO-CTCAE measurement system and the interdisciplinary consortium in which it is being developed and tested, and suggests the trial contexts in which patient reporting of toxicity is likely to provide the greatest value and informational yield, as well as the challenges faced in developing this approach to adverse event reporting. Session details... |
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 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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