By Melissa Mooney

Implementing an electronic clinical outcome assessment platform, or eCOA, is a critical step in modern clinical research for streamlining data collection, improving patient engagement and enhancing trial efficiency. However, eCOA implementation is not as simple as selecting a vendor and launching a system — it requires careful planning to prevent delays, reduce site burden and ensure high-quality data.

By following best practices, trial sponsors and site teams can navigate common challenges, optimize workflows and create a seamless experience for all stakeholders, including patients. The following four key approaches can drive the successful implementation of an eCOA platform.

Approach no. 1: Promoting patient centricity
A key priority when implementing an eCOA platform is ensuring a patient-centric design. This means developing a system that is both user-friendly and tailored to the specific needs of the patient population and therapeutic area. Key considerations include the typical patient’s age, cognitive abilities, motor skills, device preferences and offline capabilities. By leveraging real-world experiences and data, interfaces can be customized to address potential risks and challenges, which will also improve patient compliance, experience and engagement — all critical factors for compliance and data accuracy.

A secondary component of patient-centricity that is gaining traction is the Bring Your Own Device solution, also referred to as BYOD. Advantages of BYOD include increased patient confidence, stemming from comfort and familiarity with the device. Should patients not have access to adequate infrastructure, such as sufficient storage space or reliable Wi-Fi, providing devices is a valuable alternative. Offering both options ensures inclusivity and adaptability, enhancing patient satisfaction, compliance and retention.

While customization is a fantastic first step in patient-centricity, there are additional steps that can be taken to further enhance the patient experience. Integrating beneficial features, such as reminder notifications, intuitive navigation and logical branching, further supports patient engagement and completion of assessments. These features serve as a means to improve usability, compliance and collection of reliable data from diverse populations.

Approach no. 2: Agility is a must
The next consideration when adopting an eCOA platform is the ability to be agile. Clinical trials are moving at increasingly accelerated paces, and to avoid falling behind, eCOA platforms must be able to adapt to expedited study startup timelines and mid-study changes without compromising accuracy.

Agility enables the creation of customizable software, which is crucial during the startup phase. Beyond startup, agile platforms nimbly support mid-study adjustments resulting from protocol amendments. Elements of agility include auto-generated documentation, pre-built assessment libraries and seamless design and build features, which offer enhanced transparency that minimizes the risk of misinterpreting eCOA requirements, an issue that could become time-consuming and costly.

By leveraging agile eCOA platforms, implementation times can be reduced, human errors are minimized and eCOA software is developed efficiently. Platforms that place value on agility unlock the abilities of sponsors to collect necessary data points with speed and accuracy and become scalable for varying trial sizes and complexities.

Approach no. 3: Simplification is essential for site staff
A further consideration when implementing an eCOA platform is the complexities associated with site burdens. By streamlining workflows, the burdens of staff training, data management and overall system interaction can be greatly reduced.

User-friendly platforms with clear workflows and intuitive navigation offer simplification that flattens the often-frustrating learning curve for staff, enabling them to prioritize and focus on critical tasks, such as patient care, instead of mundane administrative duties. To achieve simplification, sites need to leverage tailored training, compliance monitoring and data handling. Efficient and role-specific training equips staff with the knowledge and confidence to utilize the platform to its fullest extent, remain compliant with protocols, handle patient inquiries and maintain operations efficiency throughout a trial lifecycle. Then it’s possible to further refine the platform based on feedback from site teams to ensure alignment with actual needs.

Approach no. 4: Flawless integration
The final approach for successfully implementing an eCOA platform is to build digital bridges between it and existing clinical trial systems. These connections are critical for maintaining data consistency, optimizing workflows and improving general accessibility.

Another element of integration includes automated workflows. For instance, by leveraging completed eCOA data, actions like randomization or dosing can be initiated automatically, reducing manual intervention while ensuring protocol adherence. Decreasing manual tasks reduces the opportunities for the introduction of errors, strengthens ongoing trial operations and enables accurate and efficient processes to be established.

To ensure the smooth transfer of data and interoperability, features such as APIs will be essential for electronic data capture systems and randomization tools. By condensing the number of platforms required by site staff, sponsors and site teams can relinquish some of their burdens while data freely flows across systems in a secure manner.

A non-negotiable requirement when it comes to eCOA platforms is strict adherence to global data protection regulations, including the General Data Protection Regulation and the Health Insurance Portability and Accountability Act, which are essential for maintaining patient trust and trial integrity. This is crucial in a time of ongoing cybersecurity threats. Quality benchmarks and standards set forth by regulatory bodies like the Food and Drug Administration have been established to safeguard data integrity and platform performance.

Laying the foundation for eCOA success
eCOA platforms are not just a steppingstone on the clinical trial trail, they are the guardrails that offer efficiency and patient engagement and ensure the quality of data. These approaches — patient centricity, agility, simplification of workflows and flawless integration — are all paths to streamlining trial processes and achieving better outcomes for all stakeholders. Through purposeful execution, these approaches serve not just the clinical trials they are part of, but the overall advancement of clinical research.

About the author: Melissa Mooney has over 19 years of experience in the development of eCOA solutions for use in clinical trials. Melissa’s area of expertise is eCOA solution design, where she has helped clients and eCOA vendors in develop robust and usable eCOA software solutions that meet eCOA protocol requirements. She also brings a plethora of experience in eCOA requirement gathering, leading eCOA User Acceptance Testing, eCOA data management and business development support.