The COVID-19 pandemic threw a wrench into the work for most clinical research operations, with decentralized trial technology offering hope for their research to continue. Ryan Jones, CEO of clinical trial tech company Florence, spoke with Outsourcing-Pharma about how the virus rocked the industry, and the crucial role decentralized research likely will continue to play.
OSP: Could you please provide a ‘nutshell’ description of Florence?
RJ: Florence solves a $20b [USD] clinical research access problem that no one is talking about: pharma trial sponsors only connect with their clinical trial sites with people, paper, and airplanes. This physical infrastructure impedes the remote work that’s now commonplace and slows the pace of cures.
We solve this problem through software— tools like eRegulatory, eConsent, eTMF, and eSource—built for trial sites first. Together, these applications form a digital research network connecting 10,000 sites allowing sponsors to go remote, skip the traditional monitoring visit and get an always-on connection to their studies.
OSP: When we first met in 2020 at SCOPE, COVID-19 was a blip on the radar to most of the world. Could you think back and share what you remember about those early conversations about how the virus and pandemic were impacting R&D?
RJ: Because sites and sponsors were connected only with people, paper, and airplanes, everything ground to a halt in March. Major CROs were reporting that 70% of their sites were inaccessible.
Distressingly, this meant patients depending on studies for life-saving therapies were unable to continue their treatment schedules and were in real danger. Emerging studies never left the gate.
Then, we saw a positive shift in early summer. Sponsors and CROs began using electronic tools to access sites and patients, and frozen new studies were replaced with COVID-specific protocols, so the volume of research (as reported by CT.gov) actually increased over that period.
OSP: Specifically, what were your initial conversations with clients and colleagues alike bout strategies for shifting onsite research to DCTs?
RJ: DCTs encompass a spectrum. They can be about remote connectivity to the patient through in-home or device-based trials. But they also can be about decentralizing the trial site itself, through enabling research at research-naïve clinics or allowing remote work at established professional sites.
We saw some shift to direct-to-patient, but most of the shift we saw was focused on transforming and mobilizing traditional sites—after all, sites were in use up to the minute before the pandemic.
As a consequence, the heart of the DCT discussion then was less about bringing the trial directly to the patient, and more about empowering remote work at the site—empowering clinicians and staff to work remotely, and empowering sponsor monitors and project managers to work remotely. One of our site customers, Vanderbilt Medical Center, was able to move all its research staff to remote trial work in less than a week.
OSP: How can trial tech like Florence’s solutions facilitate and accelerate the transition from brick-and-mortar sites to remote?
RJ: We help our brick-and-mortar site users with three types of transitions:
- Remote work transitions: This turned out to be a huge deal in the wake of the pandemic. In 2019, all data, content, and records were tied to the physical clinic location, preventing research teams from working from home at all. Our tools make research work location agnostic.
- Site federation transitions: This is where an experienced central site can support and enrollment at federated sites in a larger geographic area—provided they are connected with the right technology. This allows much faster and more diverse patient enrollment by removing brick-and-mortar academic centers as the only option for many studies. This is possible with our site tools that automate the creation and sharing of both regulatory and patient data.
- Direct-to-Patient Transitions: This is where patients can self-enroll in trials and self-report where they are through mobile apps that provide research tools like eConsent and ePro. This transition requires both the above transitions—as the need for research team oversight, remotely from home, persists, as does the need for local federated clinics to support certain key phases of the study.
OSP: While Delta and other variants are preventing the research industry and the rest of the world from being “post-COVID” we are at a point where we’ve learned a great deal about COVID’s impact and can at least envision life after the virus. Could you please share your thoughts about what the study landscape might look like in a post-COVID universe? Will we ever see clinical research become totally siteless?
RJ: The biggest change we’ll see in the research landscape as a result of COVID is the continued shift in technology use. Earlier this year, we released survey results from our State of Clinical Trial Technology Industry Report, uncovering that 47% of sites and 36% of sponsors indicated they increased their technology budgets to reduce disruptions from the pandemic. The data confirmed what we hear from the 10,0000 sites and hundreds of sponsors in 34 countries on our network; the pandemic forced organizations to accelerate their technology transformation plans.
As far as whether clinical research will ever become siteless – I think sites are an invaluable piece of the clinical trial research ecosystem. I see a future that’s enabled by decentralized clinical trials, but sites will play a strong role in that process. Ultimately, decentralization doesn’t mean siteless, it means localization and allowing more local and community-based health clinics and provider offices to participate in research.
Further, I would add that not only are sites vital to a decentralized clinical trial research model, but these trials are beneficial for sites. Looking ahead to a post-COVID landscape, I think sites can expect to benefit from more time for patients, the ability to connect more patients with studies, the freedom to hire new roles to support digital research, the opportunity for more remote work, and increased access to data and real-time observations.
OSP: Do you have anything to add?
RJ: One final comment I would add about the rise of decentralized clinical trials in the research space is the benefit it has in increasing diversity and inclusion among trial patients. Earlier this year, JAMA published an article on the demographics of vaccine clinical trials from July 2011 to June 2020 – showing how white people were vastly overrepresented in vaccine clinical trials, while Black, Hispanic and Indigenous people were underrepresented. That same trend was seen during COVID vaccine trials when people 65+ were underrepresented even though that population was especially vulnerable to the disease.
For cures to be effective, they need to be tested on people of many ages, gender identities, races, and ethnicities. Because decentralized technologies allow research teams to build sites where patients are, and not just where hospitals are, the result is a better chance to include diverse populations in research. At Florence, that’s something we’re acutely aware of and we are working every day to ensure our platform is optimized to support greater D&I in research.