This article is part of a Q&A series about clinical trial innovation during the Covid-19 pandemic. For more related insights, check out our Q&A with Optum's Digital Research Network.
The Covid-19 pandemic has created new awareness and urgency for life science companies, researchers, and providers to make clinical trials more accessible, modern, and patient-centered. However, clinical trial innovation is not new to the health care industry. For years, companies such as VirTrial have focused on using decentralized (away from the study site) and virtual technologies to improve clinical trials. In fact, VirTrial's vision is to replace 25% to 40% of standard clinical trial visits with decentralized clinical visits to create hybrid studies.
How to lock in crisis-driven innovation
To better understand the future of clinical trial innovation—and what's changed during the pandemic—we spoke with Kim Kundert, VirTrial's vice president of clinical operations.
Question: How has Covid-19 changed the clinical trial landscape?
Kim Kundert: Prior to Covid-19, sponsors viewed virtual components and telemedicine as a "nice to have." The industry was slow to move on these advancements, even though they help reduce many existing challenges in the clinical trial process—such as high costs for sponsors, non-representative patient populations enrolled in trials, and significant burden on clinicians and patients.
But with the onset of Covid-19 and the declaration of a national emergency and shelter-in-place orders, the clinical trial industry came to a standstill. Study participants couldn't travel to research sites for visits, and many research site staff were working remotely. This left the industry scrambling to find solutions to get the studies back on track—and quickly made virtual components and telemedicine "must haves."
Q: Thinking beyond Covid-19 and to clinical trial innovation overall, what components of clinical trials can be easily virtualized?
Kundert: Currently, the easiest components to virtualize are video check-ins. Video check-ins allow face-to-face interaction between the study participant and research site staff, and they can be used to assess adverse events, conduct visual physical exams, and evaluate the overall health of participants.
In addition, some remote monitoring can be virtualized via FDA-cleared wearables, as well as e-consent—although the process needs to be easy for participants to use and not all are.
Q: How do these virtual trial components improve the clinical trial experience for patients and/or providers?
Kundert: Telemedicine allows study providers/physicians to have the ability to still see/visualize the study participants, even if they don't come to the research site. That means that some or all study visits can be performed remotely, which reduces the time/travel burden for study participants. And since virtualization provides them greater flexibility around study visits (not having to drive to the site, which may be far away), participants may be more likely to join a trial and stay on the trial throughout the duration.
In addition, telemedicine also makes both the provider and the participant more comfortable due to safety oversight.
Q: How will trial innovation improve evidence generation for life science companies?
Kundert: This new environment or method of conducting studies will hopefully provide the evidence we all believe to be true: greater numbers of people being enrolled in trials, improved study retention rates, and an increase in the diversity of study participants—all with reduced patient burden.
Q: What are the remaining challenges and barriers to clinical trial innovation?
Kundert: There are a few remaining challenges. First, what will the regulatory landscape look like post-Covid? Will the barriers that have been removed for the pandemic be sustained?
Getting sponsors/CROs to think about all end users—not just study participants, but also study site staff—is also a challenge, in addition to obtaining site input and feedback during trial planning. Just because a technology is "sexy" doesn't mean it is the best option in the real world.
Q: What is one thing you want other parts of the health care industry to know about virtual or decentralized clinical trials?
Kundert: Decentralized clinical trials (DCT) can greatly improve efficiencies and timelines in the clinical trial lifecycle. Hybrid DCTs afford the perfect method for conducting real-world evidence trials and long-term follow up for chronic condition studies, vaccine follow up, and rare diseases research.
Ultimately, by reducing patient burden and increasing site efficiencies, more people will participate in clinical trials, fewer people will drop out, and the data needed to prove safety and effectiveness will be provided more quickly, thus getting safer drugs to market more quickly.
Q: When you think about decentralizing clinical trials, what type of cross-industry collaboration (e.g. pharma, trial sites, CROs, digital health startups, payers, FDA) would you want to see to advance virtual/decentralized trials further?
Kundert: I would love to see some kind of industry collaboration that starts with FDA outlining acceptable practices for decentralized clinical trials.
Then, it would be good for pharma/CROs/technology vendors, research sites, and patients/patient advocates to all meet on a regular basis to discuss the process and best practices for implementing DCTs, to collaborate and learn as we are implementing. Many stakeholders will surge forward with what they think is best, not taking into account the other viewpoints.
Overall, to achieve greater cross-industry collaboration, stakeholders must answer a few key questions:
- How do we keep clinicians and patients engaged in absence of in-person interactions?
- How do we ensure the validity and accuracy of data collected through virtual platforms?
- What therapeutic areas, disease states, or types of patients are virtual or decentralized trials best suited for?
- What new endpoints—traditional and digital (e.g. from smartphones or watches)—can we collect during virtual or decentralized trials? How do we ensure that the data we collect is meaningful for clinicians, regulators, payers, and patients?
- How can we generate and use data about improved rate of trial enrollment, improved patient retention rates, and improved diversity in trial enrollment to prove the ROI on trial innovation?