eCOA implementation: how to ensure equivalency with the COA paper version
As many aspects of our lives become digital, it comes as no surprise that the COA industry follows this trend as well. As a matter of fact, using a Clinical Outcome Assessment (COA) in its electronic form - eCOA - presents numerous key advantages:
- Improving the quality and consistency of the data
- Facilitating access to data
- Enhancing the patient’s experience
- Saving both money and time
But how can COA digitalization be delivered while preserving the original scale’s integrity and validity?
Based on the eCOA best practices, Mapi Research Trust has developed a rigorous process to ensure the equivalency between the electronic and the paper versions, and the validity of the data electronically collected.
The stakes of equivalency between eCOA and COA paper version
As COAs are usually developed and validated in paper format, any change to the scale (content, structure, display, or logic) can jeopardize the validity of collected data, and thus impact the entire outcome of a clinical study. As the eCOA is per se the digitized version of COA paper form, it is crucial that both versions are equivalent. If not, the lack of equivalency can be questioned by regulators, exclude meaningful comparison with other studies and lead to delays in study timelines.
A good illustration of this is based on Mapi Research Trust’s experience: in the first quarter of 2023, 98% of the screenshot reviews projects managed by Mapi Research Trust required eCOA developers to make changes to the electronic version of the COAs, and 27% of them contained substantial changes (clear change of the content or meaning). This statistic alone shows that the electronic implementation the COA may not always turn out equivalent to the paper COA, and thus rigorous migration guidance and review are key to a successful electronic implementation.
How to minimize the risks associated with COA digitalization?
To ensure the quality and validity of an eCOA, a few rules should be followed during electronic implementation:
- Respect of COA integrity and developers’ requirements
- Adherence to eCOA best practices from eCOA expert groups and guidelines from health authorities
- Protection of data integrity
- Optimal user experience
With multiple stakeholders involved in this process, it is crucial to control and streamline the eCOA implementation and certification process.
Mapi Research Trust’s methodology for successful and valid eCOA implementation
At Mapi Research Trust, our role is to standardize the digitization of COAs, and ensure alignment with the COA developers’ requirements and eCOA best practices through different aspects:
- Coordination: an optimized communication between stakeholders is key during a digitization process. Mapi Research Trust’s experts work in close collaboration with the COA developer, the sponsor and the eVendor, providing extensive feedback on the content, design and navigability.
- Process: the COA electronic implementation and certification is facilitated thanks to a rigorous process. See more details in our eCOA services webpage.
- Information: Mapi Research Trust has developed a guidance document called the eBooket designed to assist the eCOA developers during the migration process and presenting the different steps to ensure integrity is maintained
Read our whitepaper to learn more on solutions for successful and valid electronic implementation of COAs.