The biopharmaceutical sector may face a growing problem with COVID-19 at study sites in the form of interruptions to their clinical trials summarizes a new survey by Continuum Clinical. In the United States, study sites’ concerns have grown 88% from 25% to 47% over just 4 days. In the meantime, clinical sites respondents in Europe reveal 80% of sites indicate the pandemic will adversely impact clinical trial enrollment.
This March 13 survey was funded by a global clinical trial enrollment company called Continuum Clinical.
Conditions at Site Level Indicate ‘Worrisome’
Clinical investigational sites are increasingly concerned about their performance in respective studies. The rapidly escalating levels of concern reflect investigators observation on the ground—with quarantines, lockdowns and various other measures it will become increasingly difficult for patients for example, to show up for studies unless there are feasible alternatives—e.g. telehealth, etc.
69% of responding European sites report novel coronavirus has reduced already-enrolled patient willingness to continue participating in trials, compared to 47% of responding U.S. sites who indicated the same. Sponsors should be mindful of these trends as any meaningful disruption in patient participation will impact quality data.
In fact, according to Continuum Clinical’s CEO Neil Weisman, “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.”
Patient Participation May Wane in the Short Run
The survey also reveals that in both Europe and in America, clinical investigator sites report patients will be less likely to actually participate in new clinical trials due to COVID-19 concerns. For example, in Europe, 78% of the sites responding in the survey report that they believe patients were somewhat or much less willing to participate in new clinical trials while that figure was a little better at 61% of those surveyed in the United States.
Non-Academic Hospital Sites Feel the Impact
The survey also revealed that non-academic hospital sites involved with clinical trials were significantly move likely (67% up from 39% just a few days ago) to declare COVID-19 will have a big negative impact on patient recruitment and retention at their sites moving forward. Academic institutions already report decreases in the number of clinical trials they are currently conducting.
Ongoing Monitoring of the Situation
Continuum Clinical continues to field a survey to help the clinical research sector track important trends at the site level. See the link for live updates.