🔹 Uniform terminology, serving as the fundamental language, holds paramount importance across various domains of human activities, and this truth extends to the rapidly evolving domain of electronic Clinical Outcome Assessment (eCOA). As a young direction, standardizing eCOA terminology is more crucial than ever.
🔎 Terminology Clarity and Evolution:
Since the advent of electronic data collection in the 1990s, the terminology surrounding eCOA has evolved significantly and now requires greater clarity. Initially met with resistance, ePRO systems gained momentum in the new millennium due to powerful technology and the expanding evidence base supporting eCOA over traditional paper-based methods.
🌐 The Need for a Common Language:
With the continuous development, adoption, and repurposing of eCOA-related terminology, a common lexicon is essential. Without a unified language used by eCOA providers, sponsors, study site staff, measure authors, translation providers, and regulators, miscommunication, errors, and inefficiencies are more likely to occur. Standardization in technology-supported clinical research promotes efficiency and facilitates effective communication.
🤝 The eCOA: Getting Better Together Initiative (GBTI):
To address these challenges, the Critical Path Institute initiated the GBTI in 2019. It’s a collaborative effort involving C-Path, eCOA technology providers, clinical trial sponsors, and regulatory advisory input from the FDA. GBTI aims to identify and resolve issues related to eCOA implementation in clinical trials, driving positive and lasting change for all stakeholders.
📚 The eCOA Lexicon Project Team:
As part of GBTI, the eCOA Lexicon Project Team was established in 2020. Their mission was to review terminology and create an aligned lexicon for use across the eCOA ecosystem. The team generated a list of relevant terms and provided definitions based on industry sources such as the FDA/NIH BEST glossary.
📜 The Current State:
Version 3 of the eCOA Lexicon has recently been published [https://lnkd.in/gTYAuie5], building upon the previous versions. It serves as a valuable resource for stakeholders and can be accessed as a searchable PDF on the eCOA Consortium’s webpage [https://lnkd.in/gJr-8KsK].
🌟 Supporting Dialogue and Development:
At TUNECT CRO, we wholeheartedly support initiatives that foster dialogue and discussion. We firmly believe that having a standardized language for eCOA is crucial for effective communication and advancement in this rapidly evolving field.
🔗 To learn more about the importance of standardized eCOA terminology: “An eCOA Lexicon: The Quest for Single, Trusted Source of Terminology” published in Applied Clinical Trials Magazine [https://lnkd.in/gaHFN4Pk].