New Patient Enrollment Efforts Stalled by Coronavirus Obstacles

Raymond Nomizu, CEO of Clinical Research IO

Raymond Nomizu, CEO of Clinical Research IO

From movie theaters to restaurants to shopping malls, coronavirus-inspired closures are already impacting the national economy in significantly negative ways. The same phenomenon appears to be damaging clinical trials, says a new survey from Clinical Research IO.

Even at this relatively early stage in the health crisis, 24% of principal investigators (PIs) surveyed reported that they have stopped enrolling new patients due to patient safety concerns, and of the 76% remaining investigators, nearly half indicated they are considering halting new patient enrollment.

The survey was conducted March 19 to 23, 2020. In total, 73 research sites across a range of therapeutic indications participated.

“We noticed a significant slowdown in patient recruitment in the beginning of March,” said Dr. Elena Christofides, owner and PI of Endocrinology Associates. “We then decided that it was in the best interest of public safety to halt all further enrollment.”

This slowdown has been further exacerbated by the recent spate of shelter-in-place orders imposed by states and municipalities. “Due to COVID-19 restrictions in healthcare, clinical trial activity has largely come to a halt,” said Dr. Marcus Stone, CEO of the Spine Institute of Louisiana Foundation.

“This will lead to a significant slowdown in new drug and device development,” said Stone. “New treatments that could have come out in, say, 2022 now might come out in 2023. So, this COVID-19 crisis could have a significant long-term effect on healthcare in general.”

Even for sites that are continuing to enroll, significant challenges remain. The survey indicated that sites are reporting a 9% decrease in patient retention—meaning nearly one in 10 enrolled subjects may be withdrawing from their studies. Furthermore, 63% are reporting that they have prohibited onsite monitoring by pharmaceutical sponsors and their agents, thus inhibiting the ability of sponsors to perform effective oversight.

“This is one of the second-order casualties of the covid crisis,” said Raymond Nomizu, CEO of Clinical Research IO, the clinical trials software vendor that administered the survey. “When we look back five years from now, I fully expect to see a drop in the number of breakthrough new medications being approved—a drop you can directly tie to this crisis.”

Edited by Michael Causey