Advancing Electronic Clinical Outcome Assessments

By Bryan McDowell – Vice President, eCOA Clinical Science and Consulting at Clario, Dr. Kelly Dumais – Director of eCOA Science and Consulting at Clario, Dr. Valdo Arnera – Medical Scientific Advisor, eCOA Science and Consulting at Clario, and Pierre-Frederic Omnes – Executive Director at TransPerfect Life Sciences

Editor’s note: This article was adapted from the webinar “How the Recent FDA & EMA Regulations are Helping Advance and Enhance Electronic Clinical Outcome Assessments (eCOA-ePRO).” Responses have been edited for clarity. You can watch the full webinar recording here.

eCOA isn't a novel concept. Over its 25-year existence, the scientific community has acquired substantial knowledge on enhancing clinical trials through patient input and reducing patient demands. This entails posing precise questions to ensure that accurate data is gathered at the appropriate times, intervals, and locations. Achieving the right equilibrium is crucial and guarantees a more successful program.

The most recent guidelines from the EU, EMA, and FDA have been developed to promote and improve the utilization of eCOA while preserving data quality in decentralized trials and electronic submissions to ethics committees.What is evident from these current regulations and impending ones is that Clinical Trial Research (CTR) is a dynamic and ever-evolving field. As time progresses and regulatory expectations become more defined, there will undoubtedly be more insights to gain and lessons to absorb.

Until then, by establishing clear definitions of processes, learn how your teams can streamline the collection of essential data, thus alleviating patient burdens, all the while upholding data integrity within a flexible trial environment.