Tell us about your domain expertise, and your experience in providing scientific guidance in the development and adoption of eCOA/ePRO software.   

I have spent my career working at the intersection of science and technology. This includes providing guidance on the use of digital health technologies (DHTs) in clinical trials, with a core focus on digitizing the capture of COAs. My experiences have led to a deep knowledge of clinical research and study design, the technology used to support it, and the pain points experienced and how to solve them.  

I am passionate about driving the industry forward to provide optimized data capture solutions and increasing the evidence-base to do so. I recently lead a pivotal industry publication on “Best Practices for the Electronic Implementation and Migration of Patient-Reported Outcomes,” as part of the eCOA Consortium. 

In driving uMotif’s scientific strategy, I ensure that scientific, industry, and regulatory best practices are embedded across the organization. I work closely with the commercial and delivery teams to drive optimal solutions and trust with our clients. I provide scientific oversite of project setup and design, and I work with the product and engineering teams to support fit-for-purpose product development.  

There is much talk about the importance of working at the intersection of science and technology to develop patient-centric solutions, but how can we make that more common? 

We work in a very niche area of technology. As well as thinking about the regulatory implications and the data being collected, you have to remember there’s a user at the other end who might be facing significant health challenges because of their condition or treatment, or caregivers are having to care for a loved one who is unwell, which also has an impact on their life. They have a lot going on. 

We must also recognize that the site personnel are not using our technology all day every day; often clinical research is a tiny part of their day, which is mostly comprised of their usual clinical duties. 

Fundamentally, we must recognize that just because we can do something with the technology, doesn’t mean we should; that is a vital principle of the space that we work in. There are so many things we can program the technology to do, but is it actually doing something that is scientifically warranted for the study and making it easy and intuitive for the user? We have to be asking ourselves these questions every day. 

The other side of the coin is that, when we can’t quite do something with the technology easily because a requirement or request is complex, we push the onus onto the user and make it their responsibility to overcome. Our industry needs to stop doing this. Operating as if technology solves all of the problems and pain points we face, and that the interaction with it is the user’s responsibility, is not an option. 

I see this as a key part of my role of CSO, being an advocate for the users of this technology, and ensuring that they can use the technology we provide to serve their unique purpose – to integrate clinical research into their day-to-day as seamlessly as possible. Be it a patient, caregiver, CRA, investigator. Science bridges that gap between technology and empathy, and I believe that having the scientific input and perspective within the technology provider’s organization is a core component of achieving the goal of successful trials where technology is integrated.  

What excites you most about the direction of patient-focused software and apps over the next year or more? 

I am excited that we are actually seeing realization of the concept of patient-focused drug development and motivated to capture the patient’s voice. For example, something that I am very passionate about is ensuring that due consideration is paid to the accessibility of the digital solutions we build and implement.  

For too long our industry has focused too acutely on the measurement comparability of paper vs eCOA assessments in the absence of equal consideration of the accessibility of digital solutions; ensuring accessibility will undoubtedly support greater diversity and inclusion in clinical research. I am looking forward to a collective shift in focus to the user on the other end of that measure being a critical factor.  

I also think that we will see more attention paid to the site experience. Sites are fundamental to the success of a trial and the engagement of the participants. They are the linchpin, and if they are advocates for the technology, it will encourage participants to adopt it. They are often using many different systems, for the trial and also as part of their daily clinical duties, so ensuring that the site-facing technology is intuitive and supports their workflow is critical.