7 best practices for assessing eCOA technology solutions

At the onset of adopting decentralised clinical trial (DCT) models, sponsors and sites prioritise the integration of electronic clinical outcome assessments (eCOAs) as essential tools. These platforms efficiently automate the collection of patient experiences using reliable electronic measures, enabling real-time access to quantitative and qualitative insights that inform the progress of the trial and demonstrate its outcomes. Additionally, eCOAs facilitate seamless, real-time sharing of treatment-related information between patients and caregivers, eliminating the need for frequent site visits and minimising additional burdens.

Selecting the right vendor, solution, and deployment model is crucial for the successful implementation of eCOA technology in clinical research. Customisation is key to meet the unique needs of sponsors, site staff, and patients, ensuring secure data collection with minimal disruption. Many sponsors may be unsure about what to look for in an eCOA platform, how to align features with study requirements, and the necessary training and support for a seamless user experience. Without proper planning and the right vendor, there is a risk of unexpected delays, patient dissatisfaction, staff frustration, and unnecessary costs.

The value of eCOAs:

End users, including patients and site staff, expect technology to seamlessly integrate into their daily lives, offering a personalised and user-friendly experience. This expectation extends to eCOA. To ensure regular engagement with these platforms, sponsors should prioritise intuitive and data-protected technology. However, participants are often excluded from the selection process. Hence, the teams in charge of selecting the eCOA platform must prioritise advocating for the needs and preferences of all users and take into consideration the following: 

• Customisation for patients: Selecting an eCOA solution that caters to the unique needs of each patient population is crucial. The sponsor's team should gather real-world data on patients' experiences with the disease and treatment to ensure a positive patient experience. Factors such as motor skills, memory issues, neurological conditions, and sensitivities should be considered. Technology selection should account for the patients' ability to comfortably use devices and any potential sensitivities. Additionally, sponsors should assess patients' openness to using new devices or a bring your own device (BYOD) approach. Infrastructure availability, trust, and data access should also be evaluated to enhance engagement, retention, and compliance. 
• Simplified workflow for site staff: The needs of site staff should not be overlooked when evaluating eCOA technology. Site staff play a critical role in reviewing assessment results, ensuring completion rates, and transferring data. The selected technology should be simple, easily accessible, and require minimal interaction. Prioritising workflow speed and simplicity allows site staff to focus on patient care and study protocols. Quick and effortless creation of patient profiles, monitoring individual or group statuses and easy access to compliance rates are essential for efficient workflow management. 
• Data portability: Sponsors must ensure secure and efficient extraction of data from the eCOA platform. Data security and privacy measures should be thoroughly assessed at every touchpoint. Seamless data transfer through APIs, without human intervention, ensures data is sent to the destination system without additional logins or interactions. Such integrations minimise technical data tasks for site staff and ensure fast and consistent data delivery, while adhering to privacy regulations.

Best practices for assessing eCOA technology solutions 

When evaluating eCOA technology solutions, sponsors should consider various factors to make the best decision for their trials. It goes beyond assessing patient needs, site staff requirements, and data considerations. Other aspects such as timing, testing, and vendor support can significantly impact successful deployment. 

Deploying an eCOA platform may extend the trial timeline, depending on technology, customisation needs, and training requirements. Sponsors should plan ahead and engage with vendors who can expedite deployment, ensuring a seamless user experience from the trial's outset. Acting promptly is crucial, particularly for smaller sponsors with limited resources. Having a pre-existing eCOA system in place, working with a trusted technology vendor, allows study teams to focus on other critical start-up tasks and ensures a positive initial interaction for patients with the trial technology.

There are seven best practices for sponsors to consider when making eCOA technology decisions:

1. Ensure compliance with data privacy and security regulations: When implementing an eCOA platform, it is crucial to verify that the platform meets all regulatory requirements for data privacy and security, especially for global trials where diverse rules govern data collection, transmission, sharing, and storage.
2. Seamless integration with existing trial systems: Select a platform that seamlessly integrates with existing trial systems to reduce the number of systems site staff must navigate and facilitate sponsors' access to data.
3. Gather input from site staff: Seek input from site staff, leveraging their past experiences with eCOA platforms to identify preferred and disliked features when assessing vendors.
4. Conduct user acceptance testing (UAT): Allocate time for user acceptance testing (UAT) to ensure that assessments function as intended across different operating systems and meet the assessment's objectives during every interaction. Additionally, consider vendors offering pre-built APIs and pre-validated assessments for accelerated deployment.
5. Maintain data control: Maintain complete control over the data, enabling sponsors to access and retrieve it as needed for the study.
6. Establish dedicated point of contact: Establish a dedicated point of contact, such as a project manager, who will address issues, provide support, and ensure the technology operates as expected.
7. Evaluate training materials: When evaluating training materials, consider factors such as accessibility, duration, and comprehensiveness. End users, including site staff and patients, prefer user-friendly platforms with minimal training requirements and infrequent updates.

Staying prepared

eCOA technology holds immense promise for improving clinical research efficiency and effectiveness. Sponsors can select eCOA platforms that align with their trial objectives and improve the overall trial experience by considering the key factors outlined. 

The continuous evolution of eCOA technology is likely to bring even more advancements in the future, including improved customisation options, seamless integration with existing trial systems, improved data privacy and security measures, and user-friendly interfaces. Sponsors should remain informed and incorporate these developments into their decision-making processes as they develop. By embracing the potential of eCOA technology and implementing best practices, sponsors can propel the future of DCTs, ultimately benefitting patients, site staff, and the research community as a whole.