Managing Medical Devices in Digital Trials: Q&A With Flo Mowlem of ObvioHealth

Flo Mowlem, PhD, VP of Science, ObvioHealth

On March 25, ObvioHealth hosted a webinar on the execution of a medical device clinical trial for migraine titled, “Digital Clinical Trials: Avoiding Pitfalls with Intelligent Study Design.” Moderated by Flo Mowlem, PhD, VP of science at ObvioHealth, the participants were Steve Schaefer, CEO, Mi-Helper, Inc; Matty Lynch, COO, ObvioHealth; Larry Charleston IV, MD MSc FAHS, professor, department of neurology, Michigan State University, co-founder, chief consultant, and CEO, Charleston Health Neurology & Head Pain Consultants, PLLC; and Katelyn Landry, migraine clinical trial participant.

The group discussed how the medical device in this particular migraine clinical trial was used, which ultimately led to a broader discourse on the design and deployment of a remote medical device trial in general. The panelists highlighted challenges and best practices that they have observed first-hand when it comes to managing these trials.

Following the webinar, Applied Clinical Trials caught up with Mowlem to discuss her greatest takeaways from the webinar and her perspectives on digital trials.

ACT: What are some of your biggest takeaways from the webinar?

Flo Mowlem: I see the main take-aways from the webinar being that fully remote trials are entirely possible, and have great benefit for certain therapeutic areas for sponsors and participants alike. This trial is living proof that the combination of convenience and greater support for participants results in improved trial efficiency. Where full trials are not suitable, there are still many aspects of the design that can be optimized with remote and/or digital elements to reduce burden on participants and sites. Flexibility and optionality are key, and what should be kept in mind as we design clinical trials.

The guiding principles of clinical trial conduct are the same regardless of where the trial activities are taking place; the rights, safety, and well-being of participants and robustness of the data are paramount.

ACT: While remote trials relieve a lot of patient burden, what are some operational challenges you see the most in them?

Mowlem: One challenge is ensuring that both study personnel and participants are comfortable with the technology being used and the remote nature of the study design. A key part of this is building out a comprehensive onboarding and training for both of these groups. I think too often we assume that technology is intuitive and that should be enough, but we have to remember that the study personnel often have many digital systems they are having to interact with, alongside many other responsibilities they have and so they need to feel prepared and supported.

Participants in trials are often not well and daily life doesn’t necessarily stop as they are participating in a trial, and so again they need to have a good understanding of what is going to be required from them as part of the study and that they understand how to use the technology. eConsent with incorporated quizzes is a key way to ensure comprehension and reduce dropout, along with easy to understand training. These become even more paramount when a participant is not having a physical face-to-face with study personnel.

ACT: Steve Schaefer discussed some of the challenges patients face when it comes to operating medical devices. What are some ways you’ve seen ObvioHealth address some of those challenges?

Mowlem: Most of us are familiar with the experience of getting a new piece of technology and learning how to use it. In a clinical trial that exploration of device use is not quite the same, as you don’t necessarily have the luxury of allowing people to figure things out in their own time. In addition, you want to ensure participants use the device in the way intended.

Training is key here; simply providing some written instructions does not suffice, particularly in a case like the one with Mi-Helper where the participant only has one shot at getting it right. At ObvioHealth, we are really keen to make training as effective and efficient as possible. We develop engaging videos that are not overly long or onerous as the perfect way to do this. Further, we have a virtual site team on hand to support any issues participants may have with device use and ensure that issues are quickly resolved.

ACT: How important is it to maintain human intervention in trials that are mostly remote?

Mowlem: It is of the utmost importance. ObvioHealth would not have had the success we have experienced without human engagement with our participants from the outset. It is that relationship that keeps them engaged and compliant in the studies.

We can all personally look back at the pandemic, and reflect on the experience of not seeing friends, family, and colleagues. Digital solutions provided such an important way for us to interact with people we could no longer see in person and enabled us to continue functioning as best we could, but we learned that this cannot completely replace human contact. How happy and relieved were we when we got to see people in person again. As humans, we are social beings and experience interaction with humans in a clinical trial shouldn’t be seen as any different.

In trials that are mostly or all remote, the important thing is for participants to feel they have a way to connect to a human if they need to, and this also applies to sites who are responsible for the well-being and safety of their participants and want to communicate with them. Some people were desperate to get back to the office and others were happy being fully remote, whilst most people prefer a middle-ground, I think participants in clinical trials also have differing preferences, and where we can provide flexibility and optionality in the way we design them and approach them, we should.

ACT: You mentioned some digital solutions are not a “one size fits all” for different remote trials. What do stakeholders need to consider before choosing a digital solution that fits the needs of their specific trial?

Mowlem: The appropriateness will very much depend on the trial design, including the number of participants, the population, condition being studied, what the endpoints are, and where activities are taking place. The question to ask is, does this reduce burden for all stakeholders? There is always going to be some burden in clinical trials by the nature of what they are trying to achieve, but does the benefit of digital solutions prevail?