Clinical research study sites are rapidly becoming more concerned about coronavirus-related interruptions to clinical trial recruitment and retention, with domestic site concern levels jumping from 25% to 47% as of mid-March—an 88% increase over just four days, according to an ongoing study conducted by Continuum Clinical (CC), a global trial enrollment company.
Clinical trial sites in Europe that responded to the survey indicated a higher level of concern overall, with nearly 80% of sites indicating the pandemic will negatively impact clinical trial enrollment, says Nariman Nasser, Vice President of Site Engagement for Continuum.
Compared to sites in the U.S. that completed the survey on March 13, sites that completed the survey on March 17 are 88% more likely to say that COVID-19 has reduced current patient willingness to continue participating in the clinical trials they are enrolled in.
Results indicate “worrisome trends” among both U.S. and European clinical trial sites across the board: 69% of responding European sites said the novel coronavirus has reduced already-enrolled patient willingness to continue participating in trials, compared to 47% of responding U.S. sites indicating the same. This is a critical issue for sponsors, as any meaningful disruption in patient participation will impact the quality of the data, CC says.
“We are seeing strong trends in the data, with European sites likely showing more concern as they have been living with the impact of the virus for longer,” said CC President Neil Weisman. “These are important data points for our sponsor and [contract research organization] partners to be aware of as we attempt to best navigate the weeks and months ahead. Ongoing patient willingness to participate in clinical research is critical to advancing medicine, so this research impacts us all.”
Both European and U.S. sites indicate that patient willingness to participate in new clinical trials is dramatically less—78% of European sites and 61% of U.S. sites surveyed said that patients were somewhat or much less willing to participate in new trials. Sites overall do not have a positive outlook, with 76% of European sites anticipating a significant negative impact on recruitment and retention moving forward, and 37% of U.S. sites indicating the same.
“We are seeing an unprecedented shift in site sentiment over a very short time frame,” said CC Vice President of Data and Analytics Paul Ivsin.
Author: Michael Causey