COA in PROgress
The use of COA in patient-centered drug development: part 1
Apr 3, 2024
Chad Gwaltney discusses the evolving importance of COAs in drug development, emphasizing a patient-centered approach. They explore the evolution of COA guidance documents, the importance of fit for purpose PRO instruments, and the evolving acceptance of quality of life measures in drug development. The conversation highlights the shift towards patient-centric evolution in drug development and the significance of incorporating patient perspectives in regulatory decisions.
33:45
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Quick takeaways
- COAs are crucial in drug development for subjective measures, requiring understanding for reliability and validity.
- Patient-reported outcomes (PROs) are increasingly important in European regulators' focus on patient-centric research, with methodological improvements.
Deep dives
Importance of Clinical Outcome Assessments in Drug Development
Clinical outcome assessments (COAs) play a crucial role in drug development by providing measures of how a person feels or functions, contributing subjectivity that requires understanding for reliable and valid assessments. COAs have always been essential in supporting product approvals across various therapeutic areas, with a focus on standardization and development procedures. Regulatory bodies like the US FDA and the UK MHRA show increasing interest in COAs, leading to methodological guidance and a shift towards patient-centric endpoints.
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