Collecting accurate and timely data from patients plays a vital role throughout the developmental stages of a clinical trial – and the ability to quickly implement technologies to capture this data is essential. The sooner a trial is up and running, the sooner sponsors can recruit patients, collect data, and advance to market approval.

We are seeing a rapid, industry wide shift to direct-to-patient technologies, including electronic Clinical Outcomes Assessments (eCOAs), which can be rapidly implemented to capture patient reported outcomes (PROs), giving sponsors almost instant access to trends across the trial.

In clinical research, it is less than ideal to wait months for a software team from an eCOA provider to build and implement an electronic assessment for a trial. Especially when there is typically a lack of transparency throughout and you can’t preview the assessment until the end of those few months. User Acceptance Testing (UAT) is a step in the trial planning process, that is often extended when users see the finished product and realize it isn’t exactly what they envisioned.

Like most software development projects, eCOAs start with study teams writing a set of specifications envisioning the format and function of the electronic assessment. The development team from the eCOA provider takes the specification and spends weeks or even months building what is described on paper, only to have the team review it during the UAT stage prior to implementation and not be impressed with the outcome.

This means developers must tear apart their hard work to redesign the assessment with the exact right colors, button placement, and user experience that the teams had originally envisioned, but weren’t able to properly communicate. For example, let’s say that an electronic assessment for a trial needed to have a specific background color due to screen sensitivity for a migraine treatment trial. We’ll use blue as a simple reference. You’re probably thinking of a completely different blue than I am right now – there’s navy blue, royal blue, turquoise, etc. If that isn’t perfectly spelled out in the spec and requirement documents, this can be interpreted differently by the study team and developers resulting in late stage changes needed. These changes add cost and time to the process, potentially delaying trial start-up and first-patient-in timelines.

Now imagine if you could avoid this problem by doing UAT in real time – as the assessment is actually being built – to ensure full alignment of the functionality and design within the assessment.

User testing upfront: An improved methodology

User testing is an important part of the process to ensure that the end user is satisfied with the finished product. But how can users test something before it is fully configured?

Historically, you can’t. However, IQVIA has you covered as we developed our eCOA platform with this in mind to address frustrations from sponsors over the years.

Our eCOA technology enables users to design, build, and preview an assessment all in real-time. And it’s not a mock assessment that then has to be developed. As you are designing and building out an assessment within the IQVIA eCOA Sculptor tool, all the back-end development is being configured automatically so the assessment is ready for implementation once design and testing are completed.

Our design team can collaborate directly with sponsors to assemble their eCOA solution together in working design sessions – with the ability to test and preview the assessment at any point. With this capability sponsors are provided the options to choose the exact right shades for their backdrops, move buttons around the page, and test each step in the patient journey as it is built to ensure a smooth user experience prior to being fully deployed.

This not only makes the eCOA development process easier and less stressful for developers and sponsors, it can make the development process faster and less costly while mitigating any potential risks. In any project, the most expensive time to fix problems is at the end. When an assessment must be rebuilt in response to UAT, it is an added development expense, that is amplified by the delays to trial start-up.

Changing the way we think about UAT

The software development world is rapidly embracing agile project management methods that have developers working more closely with end users to design better products. Throughout the collaborative build process, developers build a set of features, then share it with users to gather their feedback, and pivot the design for the next iteration.

Our approach to real-time front-end UAT is like agile on steroids. There are no day-long sprints or rounds of feedback. It is a fully collaborative process that makes the user a primary participant in the design process. It is a better, faster, and more cost-effective method that results in higher quality eCOAs that meet the exact needs of our clients and ultimately patients.

Many sponsors are initially skeptical that UAT can be done at the onset of the eCOA design process. But once they go through this iterative design process with our technology platform, they realize how logical it is to do UAT at the beginning – in real time, when adaptions are still quick and easy to make. After that, there’s no going back.

Interested in learning more about our innovative approach? Check out these short demo videos of our eCOA solution or contact us directly at ecoa@iqvia.com to speak with an IQVIA eCOA expert today.