Pandemic sees one-quarter of investigators halting trial enrollment: poll

Outcome Health image/waiting room COVID-19 campaign
(Outcome Health)

A new survey by Clinical Research IO has found that nearly one-quarter of polled trial investigators have stopped enrolling new patients due to the COVID-19 pandemic.

The survey, conducted March 19-23 across 73 research sites in the U.S., found that 24% of investigators reported “they have stopped enrolling new patients due to patient safety concerns,” and, of the 76% remaining investigators, 37% said they are considering halting new patient enrollment.

The firm behind the poll, eSource trial research site company Clinical Research IO, said it found that investigators conducting clinical trials on a wide range of diseases “are experiencing significant interruptions in their trials due to the ongoing coronavirus crisis.”

Free Webinar

From Patient Adherence to Manufacturing Ease - Why Softgels Make Sense for Rx

Join Thermo Fisher Scientific’s upcoming webinar to learn why softgels offer numerous benefits for Rx drug development, including enhanced bioavailability, patient compliance and easy scale-up. Register Today.

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

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

This comes as the U.S. has seen more than 3,000 deaths from the pandemic so far, with a massive 160,000-plus cases at the end of March and rising.

Non-COVID-19 clinical trials have been hit hard, from Big Pharmas to small biotechs including Pfizer, Merck, Vertex, Eli Lilly and more reporting major delays to their tests amid lockdowns, fears of traveling to hospitals and a switch in focus to infectious diseases.

Many are now working on treatments, either new or repurposed, as well as vaccines, though these are likely some 18 months-plus from being approved for the general population. While treatments for COVID-19 will likely come thick and fast in the coming months and years, new therapies for other conditions could be pushed back by the same amount of time.

Stone said: “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 health care in general.”

The survey also found that some sites are reporting a 9% decrease in patient retention, with 63% saying they have prohibited on-site monitoring by pharma sponsors and their agents.

The FDA has urged companies to use virtual, telehealth and telemedicine-based platforms where possible, with the likes of Vertex already saying it will probably go down this route. But changing trial methods midway is very difficult, and the use of virtual trials is still not standard for the industry.

“This is one of the second-order casualties of the COVID crisis,” said Raymond Nomizu, CEO of Clinical Research IO. “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.”

Suggested Articles

A COVID-19 antibody diagnostic developed through a joint venture between Mount Sinai Health System and RenalytixAI has been authorized by the FDA.

Researchers at Northwestern University have trained an AI algorithm to automatically detect the signs of COVID-19 on a basic X-ray of the lungs.

Polyphor is developing an inhaled version of murepavadin, which targets Pseudomonas aeruginosa infections, but is currently given intravenously.