Modern eCOA/ePRO: A People-first Approach Paves the Way for Better Data Collection

By Bruce Hellman

Chief Patient Officer and Co-founder of uMotif

The proliferation of mobile technology, including multiple generations of progressively smarter phones, tablets, watches, and other devices, has set the stage for similar types of e-clinical innovation. It has become very clear, however, that the two types of technologies have not progressed at the same pace — which is unfortunate for all clinical trial stakeholders, most notably patients.

Since the early 2000s, we have seen rapid innovation and adoption of mobile technology. Today, 85% of Americans and 83% of the global population own a smartphone, less than two decades after their introduction. While mobile devices have become profoundly powerful, sophisticated, and technologically complex, they have also become easier to use and more intuitive – making them a preferred channel for transacting. The reason behind this apparent paradox is that they have been designed from the ground up with the user at the center of the experience.

E-clinical applications, including eCOA/ePRO, have followed a different trajectory. While they have proliferated and the industry has paid considerable lip service to patient centricity, most e-clinical applications, like trial protocols themselves, have been designed from the perspective of sponsors and investigators—and not participants.

Historically, many clinical trial data capture systems have concentrated first and foremost on the outcome measure, only later thinking about how to obtain such measures from patients or healthcare professionals. For example, many eCOA/ePRO systems have simply digitized paper-based questionnaires for mobile devices without consideration for patient usability and the new digital medium. This data-first approach has led to suboptimal solutions for patients, which are difficult and burdensome to use, offering little delight. Further, it serves to push the stakeholders in a clinical trial apart versus bringing them together around a common goal. The end result is often lower engagement and longer, more costly clinical trials.

But how can modern systems do better, giving patients a great experience, while also capturing high quality, robust data?

Over the last 10 years or so, my experience in working with patients, healthcare providers, researchers, and technologists has taught me that a few core practices are key:

In pursuit of a delightful experience

Today, in our daily lives, we expect and need to have easy, simple digital experiences which work effectively and are also aesthetically appealing. Can you imagine Ikea, British Airways, Ford, or Hilton giving you a poorly designed app that looks like it was designed in the 1990s? Modern ePRO must strive to achieve the same level of intuitive design as any leading application.

ePRO applications are ultimately competing for a user’s time. When ePRO compliance is a critical factor in the performance of a study, it’s vital that the application does everything to encourage rather than dissuade usage. Will your participant spend five minutes answering your ePRO or take a dopamine-fueled flick through cat videos on Instagram?

So firstly, modern ePRO must understand that the true competitive environment is for people’s time, and therefore the digital experience must be delightful and rewarding.

Encourage engagement through intuitive design

For many patients, taking part in a research project is a huge commitment and undertaking ‒giving their bodies, their time, and their data to help science advance new cures without payment.

Modern eCOA/ePRO systems must not only support this journey but make it simpler to take part by ensuring patients have the information and resources they need to stay engaged – and have everything they need to participate in the trial in one place. By acting as a dynamic and engaging source of content (such as study updates, information about conditions, and additional resources), reminders, notifications, and information, a modern system is a patient’s welcome companion through the study. This support can continue even after the study by continuing to use the app to capture and visualize their data as part of their own healthcare journey.

By giving participants useful information and an intuitive app that becomes an integral part of their research experience – and makes data entry and engagement become a “want to do” versus a “have to do” – we’ve seen firsthand how compliance can improve dramatically. For example, in the Hypo-METRICS study, which aimed to better understand the impacts of hypoglycaemia, we saw patients engaging with the intuitive uMotif app to enter data four times daily – achieving high compliance to an incredibly burdensome regime. It’s again about thinking first about the patient and their journey through the study – what do they need and find useful.

Recognize and reward engagement

Finally, a modern ePRO solution should ensure that the journey has been worthwhile, valued, and recognized. At its core, this means that a modern solution must embed eCOA / ePRO data capture technologies that are robust, scalable, flexible, and scientifically excellent, so the data captured can be used properly. My colleague Julia Lakeland summarized those foundation tech requirements in a companion blog.

In putting the patient first, we must ensure people are thanked. Not just a short note when they sign up, but throughout the study, at the end, and – ideally – when results of the study can be shared. Modern systems provide far more ways to do this, with little or no additional cost.

One example from a study I was involved with was giving participants continued access to the study application and the ability to view their own symptom data. Participants in this Parkinson’s Disease study really valued the ability to continue to access their own data, and kept using the app for over 1,300 days after the end of the study.

Using new AI and machine learning (AI/ML) technologies allows us to think even more creatively about the right way and right time to say thank you to participants. Providing an unexpected thank you during a study leverages game mechanics to encourage continued participation and compliance.

Modern eCOA / ePRO systems can do so much more today to meet the needs of sponsors and deliver a far better patient experience. Near ubiquitous adoption of mobile technology combined with rapid advances in AI/ML set the stage for a new era of e-clinical apps. The key to success is a human-centric focus from the ground up that ensures ease of use; provides all of the information and tools needed for participation in one place; engages and delights the participant dynamically throughout their journey (and beyond) to increase their understanding of the study and their role in it, and instills a sense of gratitude and appreciation throughout the study. Learn more about how uMotif delivers on each of these requirements.