Date: Monday, June 5th, 2023
Time: 1:15 p.m. – 4:15 p.m.
Completion rates and trends of the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) across 14 oncology clinical trials
Care Delivery and Regulatory Policy
With growing emphasis on patient-centered regulatory decision making, there is a greater need to incorporate the patient’s voice in oncology clinical trials. Regulatory guidelines outline core patient-reported outcomes (PROs) to include which can inform risk/benefit evaluation. Self-reported symptomatic adverse events (AE) form part of these core PROs, with the new 2023 draft FDA guidance acknowledging the benefits of including them to enhance the assessment of tolerability in early phase dose optimization trials. Given the clinical symptoms and disease burden in oncology, patient burden needs to be thoughtfully considered when incorporating PROs into trials. We assessed trends and feasibility of electronic data collection for symptomatic AEs by analyzing completion compliance and time to complete the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) across 14 oncology trials.
Join this poster discussion to learn about the methods used for this research along with the results and conclusions found by the authors.
Principal Scientific Advisor at Clario
Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
Scientific Advisor at Clario
Dr. Emerson is a scientist with over 15 years of experience in behavioral and social science research focusing on the role of technology in measuring and intervening on health behaviors. She has extensive experience in eCOA database design and management. She is currently a Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. In her current role she supports sponsors and CROs in eCOA design best practices and preliminary study set-up to optimize the reliability of eCOA data.
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