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Abstract:
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Traditionally treatment-related adverse events are physician-reported in oncology clinical trials. Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) can provide complementary information regarding side-effects of treatment from a patient perspective. This presentation will provide an industry perspective to the implementation of PRO-CTCAE in oncology clinical trials. There is limited information in the public domain about how to implement, monitor, analyze and report PRO-CTCAE data in oncology clinical trials. Item selection from the PRO-CTCAE item library requires a thoughtful and systematic process, it has to be done separately for each clinical trial protocol, and it requires collaboration among various stakeholders within a pharmaceutical company. It is unclear at present time to what extent PRO-CTCAE information should be monitored to ensure patient safety. Availability of only a few PRO-CTCAE translations limits its inclusion in global clinical trials at this time. Further discussion is needed among the key stakeholders (i.e., instrument developers, regulators and industry) to ensure successful implementation of PRO-CTCAE.
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