Guidance for eCOA Development in Clinical Trials

A Clinical Outcome Assessment (COA) is a measure that “describes or reflects how a patient feels, functions, or survives and can be reported by a healthcare provider, a patient, a non-clinical observer (such as a parent), or through performance of an activity or task” as described in FDA publication Clinical Outcome Assessments Medical Device Decision Making.1. While COAs have been utilized in clinical research for decades, there has been a growing recognition of their importance by regulatory agencies. Electronic Clinical Outcome The adoption of Electronic Clinical Outcome Assessments (eCOA) has increased over the years and is now common practice. eCOA involve the electronic capture of COA which introduces a critical step in the clinical trial i.e. the development and effective management of the eCOA database and data to ensure streamlined data collection, improve data quality, and enhance patient engagement in clinical trials. Oftentimes a significant portion of responsibilities, particularly set up and administration, falls under the clinical data manager[MS1] [CS2] . This paper focuses on points to consider in implementing a successful eCOA in a clinical trial. The regulatory basis for minimum standards and recommended best practices are also discussed.