In March, the FDA urged biopharmas and CROs to take a virtual approach to clinical trials in reaction to COVID-19 and the attempt to slow its spread.
Virtual trials, which can see drugs and tech delivered to patients at home with telehealth and telemedicine enacted to keep contact, has always been an interesting idea in life sciences, but it's not used across the industry anywhere near as often as traditional site-based studies.
Siteless, decentralized studies were the future, and though the likes of Google, Novartis, Amgen, Sanofi and more have signed up to the idea, centralized tests remain "the way" to do trials.
COVID-19 will change that in the near term, given that patients can no longer just turn up at central sites amid major lockdowns in the U.S., Europe and Asia. But it may have a longer and much wider impact on how trials are conducted in the future.
We sat down (virtually) with Jonathan Cotliar, M.D., chief medical officer for Science 37, a trendy Big Pharma and Big Tech-backed virtual clinical trial company, to assess its response to COVID-19’s challenges.
Ben Adams: How are you managing the complexities of COVID-19 with your trials? Has it impacted/changed how you do your trials?
Jonathan Cotliar: Already, we’ve seen sponsors and [institutional review boards] (IRBs) trying to tweak protocols to deliver capabilities such as minimizing in-person interactions for patients, employing telemedicine whenever possible and having study supplies, including investigational medicinal products, shipped directly to patients—these are elements that the Science 37 virtual model already provides, so our adjustment curve has not been as steep.
Our mobile nurses are still conducting patient visits but are using extra precaution to ensure that they neither contract the virus nor become a vehicle through which to spread it. Shifting to a virtual approach and using telemedicine can help reduce patients’ exposure to the virus and provide some measure of business continuity.
BA: Do you think, when the dust has settled on this, there will be a greater need and acceptance of virtual trials?
JC: The current situation may transform how industry stakeholders think about clinical trial execution and the inherent benefits of more patient-centric, virtual visits. Patients already want research built around their lives—if we can make research more convenient for them and mitigate some of the risks inherent in this global pandemic, virtualization seems like a logical way forward.
BA: The FDA in March is urging more of this sort of thing, and in guidance on conducting clinical trials during the COVID-19 pandemic, it said:
“With respect to efficacy assessments, FDA recommends consultation with the appropriate review division regarding protocol modifications for the collection of efficacy endpoints, such as use of virtual assessments, delays in assessments, and alternative collection of research-specific specimens, if feasible.”
JC: The FDA’s guidance provides a clear foundation for sponsors to approach IRBs and the FDA about adapting ongoing trials to a virtual model when feasible. It also signals that the agency understands the transition to virtual trials is already underway and long predated the current pandemic.
Given our experience at Science 37, we know that all elements of the clinical trial life cycle can be executed virtually—from recruitment to study closeout—and are supported by software platforms that enable collection and storage of high-quality, centralized data in real time. This approach can help keep patients and staff safe, support the wider public effort to “flatten the curve” of viral spread and provide business continuity. Additionally, this is a more patient-centric approach that may be effective in lessening the burden on healthcare systems and personnel that may be dealing with extraordinarily overwhelming circumstances due to COVID-19.
BA: How can we keep patients motivated in trials with non-COVID-19-related disorders, especially healthy volunteers for phase 1 trials?
JC: In the current climate, it will be difficult to keep patients motivated if they are participating through the traditional research model, whether “healthy” or not. Will participants in clinical trials want to travel to a hospital or doctor’s office that places them at an increased risk of exposure to COVID-19? Is that even feasible given the number of locations experiencing strict quarantine measures? So far, the answer has increasingly been "no."
The best way to motivate patients is to build research around their lives. If we can make research more convenient for them while mitigating some of the risks that the coronavirus presents, that’s what we should aim for.
BA: Will there be a shortage of medical staff to track and deliver drugs to patients for trials? And how are you managing a potential shortfall?
JC: We’ve seen a large increase in demand for direct-to-patient activities, but have been fortunate that there has been no disruption in our operations. Special considerations and extra precautions have been implemented to protect both participants and the study teams, but the reality is direct-to-patient operations for IMP delivery and in-home mobile nursing provide more safeguards and less risk than historical clinical trial practices.