Three questions (+) with…
Chief Executive Officer
Steve Rosenberg’s career in life science and healthcare spans more than 40 years. He has led the development and deployment of cloud based solutions focused on driving more integrated approaches to patient centric trial management. He joined uMotif as CEO in September 2021.
Steve shares insights on the current eCOA/ePRO landscape—both adoption and competition—as well as how modern eCOA/ePRO systems must deliver an exceptional user experience to patients as well as sites. He also discusses why it’s important to treat clinical trial participants like heroes and how technology can support this important goal.
Is there a common thread running through your conversations with customers?
Customers are just trying to conduct clinical trials and collect quality data and recruit patients and sites. They want help handling the complexities of putting devices in patients’ hands, getting patients to be able to use those devices, and what their experience will be. That’s becoming more and more of a topic of conversation. It used to be in the earlier days of eCOA/ePRO no one thought about that. You’d get a device, you’d get a text form and fill it out – and if you didn’t, you would hear from the site. And that was the end of it.
Now eCOA/ePRO is becoming more of a discussion point, and sponsors are shaping trials to make the patient experience better. Most people have a smartphone, so even with older people and people with conditions like Parkinson’s, we’re starting to see different conversations around the patient experience more than before.
What are your views on the current eCOA/ePRO landscape?
There are two parts to that question, the adoption rate in the market, and the competition. On the first part, it’s still true that about 80% of studies use some kind of patient reported component. And now the FDA is talking about patient experience data. PROs are becoming more prevalent within clinical trials. How much of those are electronic is still up for grabs, but now more and more people are using electronic patient data capture. So, I think that number’s going up from a market standpoint.
Overall, the number of trial starts has been pretty flat. Covid created a bump in trials, but that wasn’t across all therapeutic areas. If you look at the raw number of trials during the pandemic, the number actually went up significantly. That’s gone away, and now you’re seeing the non-Covid trials come back. In the market in general there’s probably the same amount of PROs, but more ePRO than before.
There’s also a rising tide in terms of the landscape. Sponsors and CROs are realizing maybe it’s time for them not to adopt 15-year-old technology on 2-year-old phones. The competitive landscape favors uMotif. People see our new interface, our great team, the top CROs coming to us. Companies that have been trying out eCOA/ePRO technology are realizing it’s time for them to adopt modern technology like uMotif’s.
You have decades of experience introducing technologies that transform clinical trials. uMotif calls itself a modern eCOA company, and you referred to its modern technology. What does that mean?
If you think about the world in 2012-2013, smartphones were pretty much everywhere, at least in the US, the UK and Western Europe. That was the landscape in which uMotif started. Ben James and Bruce Hellman began by thinking about patients recording their health and wellbeing – not about clinical research or drug companies. The stakeholders were the patient, who was happy to see their own data, and the doctor who benefited from patient self-reporting.
That orientation in itself was modern: to use a great device many people already owned to build a great app that would be easy for patients to use. Ben and Bruce started working with Parkinson’s patients, and built an app that enabled people to record their health and wellbeing every day. When they saw their neurologists every month, they could show them what life had been like.
So, the focus on the patient experience has been our mindset from the very beginning. Our user interface, the way we integrate with a patient’s daily life using their phone – nobody else even thinks about it, let alone does it.
However, it’s a misconception that if the patient is happy, sponsors will be, too. We designed our software to give sponsors a very modern, elegant way of seeing and navigating through study data, so they can easily see what’s going on. That might not sound revolutionary, but in the eCOA/ePRO market not many people have spent a lot of time worrying about the analytics and reporting behind the ePRO specifics.
Then you consider uMotif’s partnerships with wearable, remote monitoring technology companies like ActiGraph. With the engagement data we collect, the sponsor gets an unequaled, in-depth view of their patients and the sites.
Let me add that the sites are responsible for everything, and people don’t give them enough credit. Sites not only have to deploy the protocol as designed, they also need to take care of the patients and manage their safety.
And that’s the single most important thing. We enable the sites to access really detailed insights as to which patients are filling out the forms when, and what they’re saying. Sites can look at the results and make sure they understand what’s happening with every patient. That’s an extremely powerful capability, especially when there are fewer physical visits. Because we see through the lens of what patients are doing with the technology, sites get to see more data, and they see it in ways that are only possible with uMotif.
How can our industry take a more empathetic approach to clinical research participation?
I’ve been preaching for a long time now that we don’t treat clinical trial participants like the heroes they are. They’re making a huge sacrifice in time and body and effort. It’s really hard to be in an interventional drug trial with the requirements put on you, the time you have to spend in the clinic, the kinds of tests you have to undergo to make sure you’re safe. It is a major commitment.
The life sciences industry is doing better thanking patients, but as a society, we never say ‘thank you.’ Anyone who’s ever taken a new drug has benefited by the trial patient’s sacrifice and risk, and needs to express their gratitude. That’s the first step to develop empathy.
I do think trials are being defined and designed better for patients. You can’t make the participation experience perfect, because at the end of the day you’re conducting a trial with a statistical endpoint that needs to be proven. But you’ve also got to be able to make the experience as comfortable as possible. And you have to thank the patient.
Connect with Steve on LinkedIn to arrange a meeting, or to discuss more about how uMotif’s eCOA/ePRO platform can transform patient engagement in your next study.