Patient-Reporting of Symptomatic Toxicities of Cancer Treatment: Current Progress and Emerging Challenges

• Activity Number: 393 - Using Patient-Reported Outcomes to Capture Symptomatic Adverse Events in Cancer Clinical Trials: Challenges and Opportunities
• Type: Topic Contributed
• Date/Time: Tuesday, August 1, 2017 : 2:00 PM to 3:50 PM
• Sponsor: Health Policy Statistics Section
• Author(s): Sandra Anne Mitchell*
• Companies: National Cancer Institute
• Keywords: Patient-reported outcomes ; PRO-CTCAE ; cancer clinical trials ; tolerability ; side effects ; symptomatic toxicities

Abstract

Aims: This presentation summarizes the international progress made in the development, testing and implementation of the PRO-CTCAE measurement system. Current use of PRO-CTCAE in cancer clinical trials and ongoing development of this measurement system are reviewed. Methods: While adverse event reporting has traditionally emphasized clinician report using the CTCAE, the availability of a measurement system to capture symptomatic toxicity from the patient perspective opens up new opportunities to improve our understanding of treatment tolerability, and potentially to improve symptom management and care quality for patients participating in cancer clinical trials. Results: In addition to summarizing the international progress made in the development, testing and implementation of PRO-CTCAE, this presentation highlights the principles of study design and interpretation, and summarizes emerging challenges and opportunities with respect to collection, analysis and interpretation of PRO-CTCAE data. Conclusion: Ongoing development of PRO-CTCAE is focused on enhancing the utility and interpretability of PRO-CTCAE data for use by clinicians, patients, researchers, and regulators.