In every clinical trial, rapid startup is critical. If your protocol is using or considering using electronic versions of Clinical Outcome Assessments (eCOA) to capture patient data, several key steps and service areas must be coordinated simultaneously to prevent eCOA implementation from being on your study startup’s critical path and potentially delaying the overall trial.
Why use eCOA?
eCOA consists of digitizing the paper version of Clinical Outcome Assessments (COAs) to enable electronic capture of data. This electronic format presents numerous advantages for patient-centric drug development and decentralized trials:
- Drive compliance in terms of patients’ completion of questionnaire information, thanks to automatic notifications and alerts in the electronic devices used to capture those data.
- Eliminate inconsistencies often faced with paper data collection (missing, illegible, late entries).
- Reduce burden on patients (less planning than on-site visits, willingness to answer sensitive questions).
- Enhance monitoring of data thanks to direct centralization in real time.
What are the key steps of eCOA implementation?
First, it is critical to acknowledge that eCOA implementation is complex. Indeed, several individual service areas must come together seamlessly for eCOA to be delivered according to the target in the startup plan.
Here is a brief overview of all critical steps:
1. COA licensing
- Identify complete list of COAs, countries and languages required for the trial.
- Secure license agreements from copyright holders for their permission to use their COAs and derivatives.
- Ensure study usage and application match licensing requirements.
- Get approval of the original screenshots when relevant.
2. COA translation and linguistic validation
- Conceptual analysis of source COA to list concepts for harmonization of translation across countries.
- Forward and backward translation.
- Cognitive interviews and clinician’s review.
- Proofreading finalization and delivery of final target language version(s) and linguistic validation certificate(s).
3. Electronic migration of translations
- Starting point with the US English final software files & screenshots ready, and final paper translations available.
- Integration of paper translation text into software files and translation adjustments to electronic administration when needed.
- Screenshot generation by eVendor for review by the translation provider and, in some cases, by the COA copyright holder as well.
- Final validation of screenshots, after back and forth, and certification of translations.
4. eCOA system build and test
- Document design based on requirements including specific details around the build of the eCOA system.
- Screenshot generation, first of the base language and then of translations.
- System build including rigorous software testing by the eVendor.
- User Acceptance testing, ideally completed by an independent party as if in real-environment-like conditions.
- Training and device shipment.
Any failure in any of these service areas or any failure in the way these services are coordinated together means that eCOA can quickly become the critical path for startup targets, resulting in delayed submissions, Site Initiation Visit (SIV) and patient recruitment.
How to keep eCOA off the critical path?
Even though eCOA implementation is complex, simple solutions can be implemented to mitigate the risks and to ensure seamless eCOA implementation. The key is to consider eCOA as a single project across the multiple stakeholders that are involved, to collectively review all milestones and to align on timeline.
Ideally the project should be overseen by one eCOA project manager within the sponsor’s team. Then a single project plan should be set for each service provider across all key deliverables ensuring that milestones for this plan meet the study startup targets (e.g., planned submission dates and site activation dates).
This solution involves 3 implementation stages:
1. Early COA assessment
Identify, at the protocol design stage, any potential electronic implementation risks (Challenges in licensing? Available translations? Etc.).
2. Create an eCOA implementation plan
Define the baseline project plan across all service providers that will be used to govern the eCOA implementation by the eCOA project manager. Map out all key deliverables and highlight key dependencies between service providers.
3. Execute the plan
How do you actually keep the eCOA project on track during the entire study startup lifecycle? Create an eCOA project team with members across the service areas and apply an agile-like methodology.