The Coronavirus Disease 2019 (COVID-19) is wreaking havoc around the globe.
With a seemingly imminent pandemic on the horizon, healthcare organizations are rushing to prepare for the fallout. The Centers for Disease Control and Prevention warned that it expects the novel coronavirus that has sparked outbreaks around the world to begin spreading at a community level in the United States.
Nancy Messonnier, director of CDC’s National Center for Immunization and Respiratory Diseases, has said “Disruption to everyday life might be severe.” The Department of Homeland Security recommends that individuals purchase a two-week supply of water and food, as well as necessary over-the-counter medications, among other things. Government officials and corporate CEOs are cancelling events and restricting travel in an effort to thwart further spread of the virus. The general population is paying attention, and largely reacting with fear.
Healthcare organizations are taking a proactive and measured approach to preparing for a Coronavirus surge at the guidance of the CDC. Because there is a serious concern that the outbreak could turn into a pandemic, healthcare facilities will likely need to adjust the way they triage, assess and care for patients using methods that do not rely on face-to-face care.
Coronavirus and Ongoing Clinical Trials
With the public’s growing fear of contracting the Coronavirus from public places, people are especially reluctant to visit facilities that are perceived to have an increased risk of contagion. Fear of traveling to a hospital or clinic may be enough to negatively impact enrollment and recruitment of ongoing trials.
The CDC has suggested an expansion of telehealth services to help control the spread of the Coronavirus. This measure applies to all healthcare facilities, including clinical research sites. Introducing telemedicine as an option to enable remote visits within a decentralized clinical trial (DCT), provides patients with a safe, flexible, and reliable alternative to in-person visits. This is particularly true if the patients can continue to work with their existing clinics and can use the personal devices they already own for video, email, and chat communications. This approach of supplementing ongoing trials with virtual visits, is ideally suited to aid in a risk mitigation strategy for just the type of scenarios we find ourselves in with the Coronavirus.
“We have had a massive influx of inquiries from our clients in regard to potential options to help keep trials on track in light of patients’ aversion to visiting clinics in person,” said Mark Hanley, CEO, VirTrial. “With the spread of the Coronavirus, many patients are fearful of contracting the virus from a site and are being extremely cautious.”
Coronavirus and Trials in Startup
New trials in startup typically require pre-study site selection visits (PSSVs), which are conducted in-person by a Clinical Research Associate (CRA) who travels to each site. The CRA tours the site, interviews the study coordinator and physician, and completes a PSSV check-list (equipment the site has, temperature logs, SOPs, etc). In light of travel restrictions regarding the Coronavirus, timelines of new trials in startup are in danger of delay.
To mitigate the risk of such timeline delays, new technology is available that enables remote site qualification, initiation and interim monitoring visits. By using this type of service, CRAs can conduct remote visits without traveling to each research site. Smart glasses with a camera are worn by a Clinical Research Coordinator (CRC) at the site and everything the CRC sees, the CRA sees from a remote location. As the CRC conducts a virtual tour of the site wearing the glasses, HD quality video of the site is streaming to the CRA’s computer screen. Additionally, the PSSV checklist is integrated into the platform so the CRA can complete it in real time, verifying that the site has the needed equipment and space to conduct the study. The CRA can conduct video interviews with both the CRC and the PI to ensure they meet qualifications.
Preventing Delays in Clinical Research
Prior to the Coronavirus outbreak, some healthcare regulators were reluctant to realize the benefits of remote technology solutions due in part to cultural concerns and risk-aversion. Now, as disaster strikes and the need for a virtual solution is both apparent and imminent, the risk profile has shifted and willingness to embrace the technology is growing quickly.
“Most new studies should include a risk mitigation strategy to sustain their trial in the event of further spread and the inability for patients to travel,” said Craig Lipset, former Head of Clinical Innovation at Pfizer. “As an epidemiologist, a clinical trial innovator, and a patient with a chronic lung disease, I see nothing but upside in incorporating opportunities for remote visits into both general healthcare and clinical trials.”
Regulatory organizations are actively working to help limit interruption to clinical research. VirTrial is in communication with the FDA, CDC and several IRBs to seek guidance on expedited protocol amendments that would incorporate decentralized visits and keep patient visits within study visit windows. If you are concerned about delays in a new or ongoing study, contact us to discuss an expedited amendment to your study protocol.