As clinical trial sites refocus their efforts on the Covid-19 pandemic, and the Food and Drug Administration calls for virtual trials as a means to protect the safety of patients and medical staff, one of the largest contract research organizations in the world is expanding an app designed to support trials.
Raleigh, North Carolina-based PRA Health Sciences said Tuesday that it would add several new features to its Mobile Health Platform designed to allow clinical trial sponsors to continue connecting and coordinating with patients who are not able to travel to trial sites due to the pandemic. The app, the CRO said, can also be used to turn existing paper-based studies into decentralized, “siteless” studies.
Features allow sites to electronically consent and re-consent patients for use of the app, collecting consent forms to allow for delivery of products through third-party couriers, video consults and means to conduct surveys.
“As the Covid-19 pandemic continues, it will be increasingly difficult for patients to see their medical professionals in person or adhere to clinical study protocols requiring visits to sites and hospitals,” PRA chief scientific officer Kent Thoelke said in a statement. “This mobile and remote solution allows critical studies to continue, where protocols and regulatory guidelines permit, and ensures that patient safety and well-being can be maintained during a time when social distancing and relieving the burden on our healthcare system is important in fighting Covid-19.”
The spread of the SARS-CoV-2 virus has resulted in hospitals across the world becoming overwhelmed by severely ill patients and caused significant disruptions to clinical trial programs, at least those not related to the pandemic. Northwell Health, which serves the New York City metro area – now the epicenter of the pandemic in the U.S. – was able to get clinical trials for drugs to treat Covid-19 up and running rapidly in large part because it put other trial programs on hold.
Meanwhile, the FDA issued a guidance last week for running clinical trials during the pandemic, placing particular emphasis on running clinical trials virtually as a survey showed that many trial sites anticipate widespread disruption. Drugmaker Eli Lilly said this week that it was delaying new clinical trials and enrollments in ongoing ones as the pandemic has bogged down trial sites.
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