COVID-19 Concerns at US Clinical Trial Sites Jump 88% Over 4 Days

Clinical trial sites are quickly becoming more concerned about COVID-19- related interruptions to clinical trial recruitment and retention, according to a recent survey.

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The ongoing quantitative survey conducted by Continuum Clinical uncovered that both the US and Europe are facing challenges with clinical trial sites across the board.

Specifically, US clinical trial site concerns increased from 25 percent to 47 percent over just four days, an 88 percent increase.

“We are seeing an unprecedented shift in site sentiment over a very short time frame,” Paul Ivsin, Continuum vice president of data and analytics, said in the survey. “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.”

Forty-seven percent of US clinical trial sites indicated that they expect the epidemic to harm their organizations. They also reported that patient willingness to participate continues to decline.  Sixty-one percent of US sites said that patients were somewhat or much less willing to participate in new trials.

Additionally, 37 percent said of US sites stressed that they anticipate a significant negative impact on recruitment and retention moving forward, while nearly 76 percent of European sites answered the same.

Clinical trial sites in Europe saw a higher level of overall concern, with about 80 percent of sites saying that the pandemic will negatively impact clinical trial enrollment. Sixty-nine percent of responding European sites also said that COVID-19 has reduced patient willingness to continue participating in trials, according to the survey.

“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 Neil Weisman, Continuum Clinical president.

“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.”

Non-academic hospital sites in the US were noticeably more likely to believe that COVID-19 will have a negative effect on recruitment and retention at their sites going forward. And academic organizations are also already seeing a decrease in the number of clinical trials that are currently underway.

“This is not surprising data, given the volume of patients hospitals are seeing and planning to treat over the coming weeks and months,” said Nariman Nasser, Continuum Clinical vice president of site engagement. “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.”

Continuum Clinical emphasized that it will continue to publish updated data to track how the current situation unfolds in the coming weeks and provide global data and real-time updates as they are released.

Most recently, a Phase 1 clinical trial for a coronavirus vaccine is underway, according to a statement from the National Institutes of Health.

The clinical trial is taking place at Kaiser Permanente Washington Health Research Institute (KPWHR) where experts administered the first immunization to a healthy adult between ages 18 to 55 years old. The clinical trial will enroll 45 adults total and look at outcomes in the coming weeks.

“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” said Anthony S. Fauci, MD, NIAID director. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”

Two groups of participants will receive different vaccine doses. Over six weeks, experts will review and assess the safety of certain doses.

“This work is critical to national efforts to respond to the threat of this emerging virus,” said Lisa A. Jackson, MD, senior investigator at KPWHRI and study leader. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”