Science 37 is a Los Angeles, CA-based decentralized trial technology provider. The company issued the report, Navigating Clinical Trials in the Coronavirus Era, to help protect trial sponsors, research investigators, trial participants and others from negative impacts arising from the virus.
According to the company, there are approximately 40,000 clinical trials operating at any given moment, involving thousands of sites, tens of thousands of investigators, and hundreds of thousands of patients. The resource details steps pharmaceutical companies and their partners can take to help minimize risks to their businesses, and to all involved.
Safety concerns
Jonathan Cotliar, chief medical officer of Science 37, told Outsourcing-Pharma the industry is seeing concerns regarding site safety, enrollment and participation.
“Given the evolving situation with COVID-19 and current best practices around social distancing and travel restrictions, many sponsors are concerned about patient safety and the feasibility of scheduled study visits,” he said. “Will participants in a clinical trial feel comfortable going into a hospital or doctor’s office that places them at a dramatically increased risk of exposure to COVID-19? The answer will increasingly be, ‘no.’”
Cotliar added that while responsible site managers always have been mindful of barriers faced by trial participants, the disruptions caused by COVID-19 are creating an entirely new set of obstacles.
“Participation in clinical research has often entailed both major and minor inconveniences for patients—arranging transportation, childcare, time off work, etc.—but nothing on the level of the additional health risks potentially posed by COVID-19,” he told us. “Now that sites and sponsors are being faced with these issues, they have to act quickly to maintain patient confidence.”
Decentralized technology
The recommendations issued in “Navigating Clinical Trials in the Coronavirus Era” include use of telemedicine investigators and at-home visits from clinical trial nurses to replace site visits. With the use of decentralized trial technologies, the report states, most trial visits can be conducted remotely.
Additionally, the Science 37 report states, mobile research nurses that adhere to all CDC-suggested precautions can safely be deployed to patient homes, in order to collect samples, monitor vital signs, complete protocol-specific steps, and collect data. What’s more, studies show many patients prefer remote, one-on-one visits to traveling to a site or local lab.
Lasting effects
Cotliar also suggested the impacts caused by COVID-19 on clinical trial planning and execution likely will create both short- and long-term changes.
“In the short-term, we’ve seen sponsors and IRBs scrambling to adjust protocols to deliver capabilities that our virtual model already provides, such as minimizing in-person touchpoints for patients, employing telemedicine whenever possible, and having study supplies shipped directly to patients,” he said.
“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.”
Other recommendations outlined in the report, available for free download on the Science 37 website, cover considerations for virtualizing protocols in order to minimize in-person interactions, and to reduce exposure for patients with particular health vulnerabilities.
