Patient-Focused Drug Development: eCOA Best Practices And Patient Engagement

In line with the 21st Century Cures Act and The FDA Reauthorization Act of 2017 Title I, the United States Food and Drug Administration (FDA) has initiated Patient-Focused Drug Development (PFDD) initiatives. The primary objective of PFDD is to amplify the patient's perspective in drug development and evaluation processes, which includes implementing strategies and guidelines to streamline patient enrollment and alleviate the burden of participation in clinical trials.

During this presentation, the following speakers provide insights on how industry stakeholders can enrich participants' clinical trial journeys in harmony with PFDD objectives:

• Celeste A. Elash, MS, Vice President of eCOA Science, YPrime
• Nadia Aleksieva, User Experience (UX) Researcher for Product Design, YPrime
• Kristy Birchard, M.S., Product Owner, Patient Engagement, YPrime

The speakers also cover the utilization of eCOA systems that adhere to the recently issued Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcome Measures, integrate features promoting patient engagement, and employ user testing methodologies to ensure acceptance of eCOA systems and enhance user experience.