Sites Struggle to Remain Solvent Amidst Trial Slowdown

Gen Li, President, Phesi

Alarming economic news continues to pummel the clinical trial industry as more and more trials are stalled or even scrapped while industry tries to navigate its way through the COVID-19 pandemic.

Earlier this month, an ongoing quantitative survey conducted by Continuum Clinical in partnership with the Association of Clinical Research Professionals (ACRP) found 31% of clinical research study sites fear total closure as COVID-19-related stay-at-home orders and patient concerns over interacting with healthcare professionals continue to increase. Nearly 80% of sites indicated at least one of their current clinical trials had been put on hold or cancelled in recent weeks.

Even before the coronavirus hit, the clinical trial infrastructure was straining under a shorthanded workforce and tight financial margins. For example, 59% of sites in 2019 told the Society for Clinical Research Sites (SCRS) that they have only three months or less of operating cash.

Unfortunately, the dire news continues to pour in for beleaguered sites, according to an April 20 analysis of a global dataset covering more than 300,000 recruiting sites around the world by Phesi that found an “alarming” 10% spike in site suspensions in the past two months. “The timing aligns perfectly with the COVID-19” pandemic upending life in the U.S. and around the globe, says Phesi President Gen Li.

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Sites are struggling and some are mulling or have gone ahead and furloughed some staff. The short- and long-term consequences will be negative and significant, says ACRP Executive Director Jim Kremidas. “In addition to putting highly qualified and valuable professionals on the shelf during a healthcare crisis, site cutbacks will make it very difficult for the industry to get back up and running as the impact of COVID-19 recedes,” Kremidas says.

The financial costs to a sponsor to replace a lost site is at least $30,000, Li estimates. In addition to the financial hit, time will be lost, typically three months or more, and possibly patient data and other trial results during the interim, he adds. “The situation is alarming and frankly has me concerned” for the clinical trial infrastructure, Li says.

And it’s not as simple as flipping an “on” switch to get a stalled trial back on track, Kremidas notes. “Learning a new trial protocol is akin to learning a new type of software,” he says. “It takes time to become familiar with both, and it’s easy to become rusty on both if you stop using them for any length of time,” he adds.

“Sponsors need to think about the financial stability of their clinical development supply chain, and sites are the most crucial link in it,” Kremidas says. “We urge sponsors, contract research organizations, and other interested parties to help us deliver educational resources now to help everyone operate more effectively throughout this difficult time, and to speed up restarting of trials once we’re past this crisis.”

In addition, ACRP joins SCRS’s call for sponsors to release site payment holdback funds during the crisis.

“There’s going to be a level of permanent damage,” Li says. “It’s up to us now to make it as small as possible.”

Author: Michael Causey