Trials 'unable to bounce back' after COVID-19 chaos: report

Clinical trial firm Phesi’s new report is some grim reading for the life science industry: Despite some forward motion over the summer, studies for new drugs are still suffering.

Phesi, which offers trial solutions to life science companies, says its data “show clinical trial suspensions continue to rise as COVID-19 impact on development persists,” adding that costs are set to “spiral out of control” if companies fail to become data-driven by next year (a service it also offers).

Others, such as biopharma analytics firm GlobalData, have been more positive, seeing upward trends in trials returning to normal. A new report out by Frost & Sullivan this month also saw green shoots of recovery for CROs.

But Phesi is still seeing major roadblocks. Its previous analysis in May found that of 300,000 global clinical trial sites, there had been a 38% increase in suspensions from the beginning of the year.

Now, new analysis from this month indicates these suspensions peaked in early June and, after an initial drop, have risen again, with over 28,000 sites currently suspended.

Sites did begin recruiting again in June 2020, rising to almost pre-pandemic levels, but while these new sites have appeared, many other investigator sites could go under forever.

“The sudden increase in recruiting sites is likely due to sponsors scrambling to mitigate the impact of COVID-19 and blindly adding new sites, without analyzing via systematical root cause analysis how well their trials were doing in the first place before the pandemic struck,” the firm said in its report.

The hardest hit are phase 2 and 3 trials, the most important for biopharmas given the mounting costs and the need for these to wrap up for approvals.

Typically, around 125 trials complete enrollment in a month. Phesi found that this swelled to 200 in June, “most likely to compensate for recruitment being at a standstill in the previous three months,” but then dropped massively to just 70 last month.

“With increased global economic uncertainty facing all industries, 2021 will be challenging for most clinical development organizations around the world,” said Gen Li, Ph.D., president at Phesi. “Without data-driven decision making, already limited financial resources will be further wasted by resurrecting ‘zombie’ projects which would have failed even without COVID-19.

“Costs may also spiral as change orders issued by CROs increase and additional internal contingency planning is required. If organizations do not adapt to these changes it could, in the worst-case scenario, lead to company meltdown and multiple year delays in the development of new therapies. Clinical development companies must have predictive scenario modelling capabilities to accurately manage new change orders and associated costs.”