A Conversation with Freenome and Jonathan Cotliar, M.D., Chief Medical Officer, Science 37
In a few words, what is Science 37 and what is the benefit of decentralized clinical trials?
We are a technology-enabled clinical research organization. Our mission is faster, more inclusive, patient-friendly research with universal access for everybody. We are a clinical trial site, but we’re a virtual site. We conduct decentralized clinical trials (DCTs), and what really makes us distinct is that we're end-to-end, from potential participant outreach to database lock. We support patients throughout the entirety of the trial in every aspect.
What we're providing is optionality for patients, those who participate in research by going to a site, and those who—because of their preference or their proximity to the nearest brick-and-mortar site—traditionally have not been able to. We provide an option for them to participate in that same trial but from the comfort of their own home.
The majority of people would participate in a trial if they could, but a significant percentage live two hours or more from the nearest brick-and-mortar site. DCTs enable access to patient populations who don't live in proximity, and because of that, they increase diversity in trials. DCTs create access—especially for underrepresented populations—in a unique way. And our model is not mutually exclusive to the traditional trial. The PREEMPT CRC trial is a good example of this because we had traditional brick-and-mortar sites and virtual sites. In our view, that’s a best-case scenario.
Why do you think the PREEMPT CRC study is important, and what do you expect is the impact for patients? Who will benefit the most from this study?
I think the importance of PREEMPT CRC is demonstrating that emerging technologies and emerging modalities, particularly in the area of age-appropriate cancer screening, are really important. We have to continuously challenge existing paradigms to figure out if something, for example, a colonoscopy, is still the gold standard, or if there are more sensitive, cost-effective ways that are easier for patients to access. With PREEMPT CRC, you are developing a cancer screening modality that is easier for patients to perform because it's independent of physicians having to be in the same room as patients.
Assuming that the trials that are testing out these modalities are medically and scientifically rigorous, and the data suggests that these are certainly proper ways of performing cancer screening, then why not give optionality to patients?
This is why PREEMPT CRC is very important, and it will be patients who benefit.
PREEMPT CRC kicked off in May 2020 and the effect of the COVID-19 pandemic was felt immediately. How were clinical trials affected during the pandemic, and what impact do you see for DCTs?
When COVID hit, we didn't have to change anything because the methodologies by which we were supporting patients in clinical trials weren't disrupted. I remember speaking to the executive team at Freenome during the initial phases of the lockdown, and there was tremendous concern about the implications for the PREEMPT CRC study. Most, if not all, brick-and-mortar sites that were already active or soon to be active on that study were shut down.
From a tactical standpoint, the team asked us how we can help. Participants could do a blood draw in the home, but they were also supposed to go out and get a colonoscopy and GI centers that do those were shut down. Science 37 was actively working with GI doctors, many of whom were research naïve but were performing the standard of care, screening colonoscopies. We were able to partner with those GI doctors in a way that eliminated the need to go to an already pre-qualified activated site. In very short order, we were able to get blood draws and colonoscopies done in a way that circumvented the lockdowns.
I think it really speaks to giving patients choice. Choice could be in the context of providing options for participation in a clinical trial, or it could mean giving patients choice in the context of age-appropriate cancer screening.
More broadly, COVID changed the way investigators and others think about decentralized trials. There was no other way during the pandemic, and I think it demonstrated to some of the naysayers within our ecosystem that DCTs are not only feasible but can be done without any loss of quality or safety. Essentially, the pandemic was rocket fuel for DCTs.
If there was one takeaway you would share with the other principal investigators and their teams, what would you share?
At a time when the entire world was shut down, we were enrolling several hundred patients every month. For us to be able to work with the Freenome team and our respective network of providers and patients so seamlessly at a time of high stress to advance science—it was cool to be a part of that. That was the highlight for me.