New COVID-19 mutations putting a strain on trial resumptions: report

The New Urgency of Clinical Trials

The new strains of COVID-19 that are more transmissible and potentially able to dampen vaccine efforts are causing clinical trial resumptions to slow.

This is according to life science analytics firm GlobalData, which found that while many studies were on their way to restarting as the global peak started to decline last year, the recent surge in cases in the West—predominately due to new, more transmissible strains first seen in the U.K., Brazil and South Africa—has “led to increased restrictive measures and has slowed down the resumption of disrupted clinical trials."

As of Jan. 25, GlobalData found that 929 disrupted trials have resumed and, out of these, 71.9% are currently recruiting participants, 12.8% have completed recruitment but are still ongoing and 0.5% of trials have yet to start recruiting subjects.

“There is a slight, steady increase of trials resuming activity, with the initial general trend showing a gradual increase in the overall percentage of trials for each trial status,” said Priya Nair, a trials intelligence analyst at GlobalData.

“However, between December 23 and January 25, ongoing recruiting trials decreased from 74.6% to 71.9%, and completed trials increased from 10.6% to 12.8%. The majority of trial disruptions can be attributed to patient safety measures, strict lockdown requirements, social distancing procedures and the high demand on medical professionals to treat COVID-19 patients.”

Geographically, the U.S. has the highest number of resumed trials at 87.5%, followed by the U.K. at 10.8% (which has issued national lockdowns since December amid its new strain), Spain at 9%, France at 8.8% and Germany at 8.1%.

Nair said here was hope on the horizon in the form of  Pfizer-BioNTech, University of Oxford-AstraZeneca and Moderna’s vaccines, which could help decrease cases, hospitalizations and deaths in the coming months. “If this occurs, then the potential of disrupted trials resuming could be likely.”

Nair added, though, this will also depend on how well the shots work against the new variants, some of which may be partially resistant to the effects of the current crop of vaccines.