US Clinical Trial Site Concerns Over COVID-19 Impact on Enrollment Jumps by 88% in Just 4 Days

European site enrollment concerns near 80%

An ongoing quantitative survey conducted by Continuum Clinical shows clinical research study sites are rapidly becoming more concerned about COVID-19-related interruptions to clinical trial recruitment and retention, with US site concern jumping from 25% to 47% – an 88% increase over just 4 days. Clinical trial sites in Europe who 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.

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Compared to sites in the US 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. (Graphic: Business Wire)

On March 17, Continuum Clinical, a global clinical trial enrollment company specializing in fact-based strategies, gathered follow up results from their original March 13 survey. Results indicate worrisome trends among both US 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 US sites who indicated the same. This is a critical issue for sponsors as any meaningful disruption in patient participation will impact the quality of the data.

“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 Continuum Clinical president Neil Weisman. “These are important data points for our sponsor and CRO 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 US sites indicate that patient willingness to participate in new clinical trials is dramatically less – 78% of European sites and 61% of US sites surveyed said that patients were somewhat or much less willing to participate in new trials. Sites overall do not have a positive outlook on trials moving forward, with 76% of European sites anticipating a significant negative impact on recruitment and retention moving forward, and 37% of US sites indicating the same.

“We are seeing an unprecedented shift in site sentiment over a very short time frame,” said Continuum Clinical Vice President of Data and Analytics Paul Ivsin. “We need to continue monitoring these trends and building fact-based planning scenarios to help sites and sponsors prepare for a period of very different patient recruitment and retention patterns.”

In the survey, non-academic hospital sites in the US were significantly more likely (67% – up from 39% just days ago) to say COVID-19 will have a big negative impact on recruitment and retention at their site moving forward. Academic institutions are indicating they are already seeing a decrease in the number of clinical trials they are currently conducting.

“This is not surprising data, given the volume of patients hospitals are seeing and planning to treat over the coming weeks and months,” said Continuum Clinical Vice President of Site Engagement Nariman Nasser. “That being said, we expect to see similar challenges for all sites, both hospital and community-based, and this will ultimately impact all clinical trials across the globe.”

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