Electronic Clinical Outcomes Assessments (eCOAs) have become a cornerstone of digital clinical trials due to the critical role they play in collecting accurate and timely data from patients throughout the developmental stages of a clinical trial. They are also valuable for their ability to be implemented to capture patient reported data, giving sponsors almost instant access to trends across the trial. The advancement of this technology is pivotal, as the sooner a trial is up and running, the sooner sponsors can recruit patients, collect data, and advance to market approval. 

User acceptance testing (UAT) is a crucial process to validate that the eCOA has been designed to optimize the patient experience, meet the needs of the protocol, and deliver the insights needed to complete the trial. However, with the pressure to continue to improve trial efficiencies, the traditional approach to conducting UAT only after the eCOA design process is complete can lead to unforeseen setbacks if major changes need to be made to the eCOAs. This can be avoided by conducting UAT in parallel with the eCOA being built, to ensure full alignment of the functionality and design within the assessment. 

Challenges of traditional UAT
At the start of implementing an eCOA, study teams work to draft a set of specifications envisioning the format and function of the assessment. The process from design to implementation has traditionally taken weeks to months, and sponsors are often unable to preview the eCOA until the end of that period. UAT, now more vital than ever in the age of patient centricity, is a step that often must be pushed out until design is complete. And if it doesn’t go well, sponsors are left to tear apart their hard work and go back to the drawing board with the user feedback in mind. 

As much of the clinical research landscape undergoes massive digital transformation, this is an area that can and should evolve to improve efficiency and patient experience. With recent advances in technology capabilities further expedited by COVID-19, sponsors now have the ability to consider taking steps to evolve their eCOA and UAT processes to design, build, and preview an assessment all in parallel rather than succession. 

Key benefits of embedded UAT
UAT is a critical part of any software development project process to ensure that the end user is satisfied with the finished product and that the product meets the business requirements. This is especially the case in the eCOA design process since time is of the essence when you are launching a study and going back and forth with researchers to gather requirements, program, test, and deploy takes unnecessary time. It is to the advantage of both the sponsor and development team to take an embedded approach to UAT. There are Key benefits include: 

·       Efficiency: Beginning UAT at the onset of the eCOA process can make the development process faster and shave weeks off start time. Creating and validating an eCOA from scratch for each study can be a lengthy process that can add months to the trial planning process, and even small errors can lead to setbacks. Embedding UAT upfront in the process is a faster and more efficient method that results in a high quality eCOA that meets the exact needs of our clients and ultimately patients.

·       Collaboration: When leveraging real-time, embedded UAT, there is no need to have multiple rounds of back-and-forth feedback. It creates the opportunity for transparency and a fully collaborative process that makes the user a primary participant in the design process.

·       Cost-effectiveness: With an eCOA development process that is easier and less stressful for developers and sponsors, it can make the development process faster and less costly while mitigating any potential risks. Like any development project, the most expensive time to fix problems is at the end. When an assessment needs to be redesigned in response to UAT, it creates added development cycles and expense. 

Creating a collaborative and efficient eCOA 
As sponsors feel the heat to make their trials more adaptive and efficient, UAT will need to be an embedded part of the design process rather than an afterthought, and with the right technology, the traditional approach will fall by the wayside. Looking forward, the benefits of executing UAT while designing an eCOA will become the new industry standard. By incorporating an agile development process with embedded UAT, sponsors and researchers can collaborate in real time, creating efficiency, transparency, and keeping trials moving forward toward eventual approval.