Title: Qualitative Synthesis of Cognitive Debriefing and Usability Testing Studies to Inform Good Electronic Clinical Outcome Assessment Design
Poster Session 1
Date: Monday, May 8th, 2023
Time: 9:45 a.m. – 1:15 p.m. ET
Regulatory agencies are placing increasing importance on the patient voice in clinical drug development. The FDA’s Patient-Focused Drug Development guidances emphasize the importance of high-quality measures and recommend developers follow best practices when designing clinical outcome assessments (COA) to avoid common issues that could interfere with respondent understanding as intended. The gold standard for measuring respondent understanding is the cognitive interview or cognitive debriefing (CD). However, access to the findings of CDs across a diversity of therapeutic areas is limited. Therefore, the objective of this research was to perform a qualitative synthesis of cognitive debriefing and usability testing (CD/UT) studies of electronic COA (eCOA) across several therapeutic areas to ascertain common issues identified by patients/caregivers to help inform good eCOA design.
Additional poster authors:
Senior Scientific Advisor eCOA Clinical Science and Consulting at Clario
Dr. Tressel Gary has over five years of experience in clinical trial design and strategy, and more than two years of experience in ePRO and the development and validation of PROs in support of labeling claims. She has significant experience working with PRO development and validation studies, questionnaire design and working with developers of standardized instruments. She is experienced in migration studies including cognitive debriefing and usability testing in a number of therapeutic areas.
Her clinical research experience was focused on hemostasis/thrombosis, platelet biology, oncology, angiogenesis, atherosclerosis and cardiovascular disease. She has extensive in vivo and in vitro lab experience and has conducted preclinical studies in support of trials. To date, Dr. Tressel Gary has co-authored 12 publications and received several honors and awards, including an AHA Postdoctoral Fellowship.