eCOA Libraries: An Untapped Opportunity?

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The process of migrating translated and linguistically validated clinical outcome assessments (COAs) into electronic platforms for use in clinical trials is a known pain point within clinical trial practice, with this activity often on the critical path. Historically, this timeline pressure is often a result of the electronic clinical outcome assessment (eCOA) technical build, which includes all the COA measures to be completed in that trial, being created anew for each trial. The COA translations are then commonly migrated into the eCOA build, creating a process in which migration and proofreading activities are unnecessarily repeated for each trial, rather than reused efficiently from trial to trial.

The solution proposed by the eCOA Consortium is the establishment of eCOA libraries, which store validated and approved versions of each measure and its accompanying translations, and which facilitates reuse these materials across studies, leading to substantially simplified workflows and reduced timelines. However, full adoption of the eCOA library approach has been slow across the industry due to a variety of complications encountered by eCOA providers, linguistic service providers (LSPs) and sponsors.

A key challenge in establishing eCOA libraries has been the lack of a clear definition of the concept. Some eCOA providers consider a library to be any form of reuse across studies, while others attempt to create comprehensive certified collections of COAs and their translations in one library to be used across all applicable trials. Further complicating matters are the requirements of various stakeholders, which often push against the concept of a comprehensive library approach. Sponsors, for example, often seek to modify COAs, patient diaries, and patient-facing instructional text from study to study, which puts eCOA providers in a challenging position, as these requests require constant study-specific adaptations of the (theoretically) static eCOA library.

Copyright issues present additional challenges; copyright holders may or may not be willing to include their intellectual property within multiple eCOA provider-specific libraries due to misplaced concerns about copyright infringement, or the need to regularly update each library owner whenever changes to the measure or its translations are made.

The eCOA Consortium has developed a series of short- and long-term recommendations designed to facilitate further adoption of the eCOA library approach. If implemented correctly, eCOA libraries have clear advantages for all stakeholders when compared to the standard workflow, including reduced costs from LSPs and significantly reduced implementation timelines.

At present, all eCOA providers use distinct software, processes, and file types (e.g., XML, JSON, etc.), making establishment of a master eCOA library used across eCOA providers prohibitive. However, there are key steps that can be taken to facilitate establishment of eCOA provider-specific libraries. These include:

• Copyright holder engagement to obtain approval of eCOA builds for their measures.
• Engagement with well-qualified translation providers responsible for migrating and proofreading the contents of the library, including a proofreading step for each trial to ensure alignment of library contents with copyrighted COA text.
• Assignment of designated eCOA providers to all trials within particular programs to ensure eCOA reuse across the program.
• Consistent use of eCOA file types and coding by each eCOA provider to ensure applicability across studies.
• Elimination of modifications by the sponsor to the text of COAs, especially patient-facing instructional text. This component is a challenge, as sponsors have historically mandated the modification of this text to suit the needs of a particular trial; this practice must be eliminated for eCOA libraries to be deployed effectively across studies.

In the longer term, we hope for consolidation of technical files and programming specifications across eCOA providers, so that efficiency gains can be achieved, regardless of which eCOA provider is selected. While this would increase the reach and efficacy of eCOA libraries, it would be quite challenging to implement, particularly as there may not be sufficient impetus for eCOA providers to collaborate and standardize ways of working with their competitors. Our ambition to harmonize will continue.

Authored on behalf of Critical Path Institute’s eCOA Consortium by Shawn McKown, Vice President, Clinical Outcome Assessments, RWS; Aisling Curran, Senior Manager, eCOA Services, MAPI Research Trust; Karl McEvoy, Product Manager, YPrime; and Mark Wade, Global Practice Leader – Life Sciences, TransPerfect.