According to the figures, COVID-19 continues to create challenges for clinical research professionals. A similar study released in May found that in an analysis of 300,000 sites worldwide there had been an increase in suspensions since the start of the year of about 38%; the latest figures show the rate of suspensions peaked in early June, dropped, and have risen again (with about 28,000 sites currently on hold.
“COVID-19 has hit clinical trial infrastructure hard, especially at the beginning of worldwide lockdowns as the industry has a heavy reliance on in-person interactions, which led to widespread site suspensions between March and May 2020,” Phesi president Gen Li told Outsourcing-Pharma. “Many sponsors also quickly had to shift their focus onto therapies to help stop and treat COVID-19, meaning other vital research projects were halted.”
The study shows sites showed a strong recovery in June, with recruitment rising to near pre-pandemic levels. However, Phesi’s September analysis shows that, although new sites have opened for business, other sites are in peril of closing forever.
Sites did begin recruiting again in June 2020, with numbers rising to almost pre-pandemic levels. Still, the analysis shows that while new sites have appeared, many other investigator sites could go under forever.
The report authors figure the increase in recruiting sites happened most likely thanks to sponsors wracking their brains for ways to mitigate COVID-19’s impact, possibly adding sites, without first analyzing via systematical root cause analysis how well their trials were doing before the virus struck.
Li pointed out that while COVID-19 is compounding challenges and introducing new problems, trial interruptions happen even in more conventional times.
“There are many reasons cause a clinical trial to fail,” he explained. "Clinical trials fundamentally are part of innovation and medical scientific experiment."
Common reasons a trial is paused or ended, Li said, include safety concerns and enrollment difficulties.
“A common root cause for these failures, though, has to do with the design of these clinical trials, particularly for the trials cannot recruit enough patients in a reasonable time frame. We estimate the failure rate related to these are around 20%,” he said.
What’s more, Li explained, COVID-19 may be merely adding to the pile of problems of already faulty trials.
“Adding an extra site can actually just exacerbate existing problems when decisions are not data-led, rather than solving them,” he said. “Organizations planning budgets for 2021 need to take a data-driven view in order to make accurate clinical development decisions that will help them navigate the difficult conditions the sector is facing.”
The analysis of data on closures also indicates COVID-19 is significantly impacting Phase II and Phase III trials: Typically, around 125 trials complete enrollment in a month; in June 2020, this almost doubled to 200 trials, most likely to compensate for recruitment being at a standstill in the previous three months.
Clinical trial enrollment closures then fell to just 70 in August; according to Phesi’s analysis, closure decisions in June were not made in a vacuum, and it is likely these trials were only one to two months from completing targeted enrollment before the pandemic, so there is a strong chance there would have been a large enough sample size already to draw statistically meaningful conclusions.
Li recommended that trial teams looking to decrease their chances of incurring interruptions should consider a more data-driven approach to trial design and operation.
“CROs and sponsors need to ensure they are using a structured live data environment which will allow them to connect data points and make measurable and consistent improvements,” he stated. “In order to manage the impact of COVID-19 on a trial, sponsors need access to real-time tracking of infection hotspots so they can identify patients to participate, and to account for the impact of local lockdown or stay-at-home regulations on patient availability.”
