What is eCOA?

As FDA Principal Deputy Commissioner Janet Woodcock said in a 2015 Clinical Outcome Assessment Public Workshop, “It turns out that what is really bothering the patient and what is really bothering the doctor can be radically different things...patients are true experts in their disease.”

Clinical outcome assessments (COAs) have been key to capturing a comprehensive picture of patient experiences and treatment outcomes in today’s research landscape for decades. Integrating COAs into trial protocols bolsters our treatments' scientific integrity and enhances our ability to understand the real impact of interventions on patients. 

COAs (called eCOAs when captured electronically) are essential to understanding whether a drug reduces symptoms, improves patients’ quality of life, and improves their ability to perform activities they care about. 

Since the mid-2010s, electronic clinical solutions, like eCOA, have rapidly replaced their paper counterparts. Electronic Clinical Outcome Assessments comprise systematized digital methods for capturing patient-centered outcomes in clinical trials. These systems utilize validated electronic interfaces to collect, store, and analyze patient-reported data, clinician observations, and performance metrics.

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On Friday, November 15, 2024, the Decentralized Trials & Research Alliance (DTRA) held a fireside chat between Brandon Maggio, GSK’s Global Head of Digital Operations & Process Optimization, and Alison Holland, Medable’s Chief Customer Officer. They were gathered to discuss the evolving landscape of decentralized and digital clinical trials and how best to drive change management in an era of continual changes within trial research. The following blog is a summary of their discussion.

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Discover how advanced eCOA platforms improve patient adherence, ensuring reliable data and faster trial completion. Explore real-world successes, including adherence rates exceeding 90% in diabetes and oncology studies, powered by Medable’s eCOA (electronic clinical outcomes assessment) solutions.