More than two-thirds of trials hit by COVID-19 enrollment halts, with midstage tests the worst affected

Nearly 200 companies have stopped or delayed their trials over the pandemic, and life science analytics firm GlobalData has dug into the data and found the main culprit has been suspended enrollment.

Drilling down into the numbers of the causes stopping these tests, it found 67.3% of clinical trials disrupted by COVID-19 are due to patients not being allowed into studies, while the delayed start of planned trials follows at 18.4%; finally, 14.4% of trials are currently being impacted due to slow enrollment.

Within the 14.4% of trials affected by slow enrollment, 20.7% of these are specifically due to the availability of sites and investigators, it found.

Brooke Wilson, associate director, trials intelligence at GlobalData, said: “Non-COVID-19 trials are being delayed or deprioritized, and clinical trials for respiratory indications may be further impacted. Many hospitals that serve as trial sites are being inundated with COVID-19 patients and are no longer available.

“For that same reason, many investigators may be repurposed to COVID-19 drug discovery trials or treating COVID-19 patients, whilst the activation of sites for non-COVID-19 trials are being deprioritized. There is also a high risk to subjects in a clinical trial who have a serious chronic or acute condition that affects their immune system, giving them a greater chance of contracting COVID-19.”

GlobalData also found there are currently 322 companies that are the sponsor, collaborator or CRO reporting specific disruption to clinical trials in the public domain, and 179 of these are private or public companies. Half of these are in the U.S., followed by the U.K. at 10.6%, France at 5%, Switzerland at 5% and Canada at 3.9%.

Wilson adds: “The majority of disrupted clinical trials are in phase 2, at 44.8%, followed by phase 1 with 26.1%, phase 3 with 21.7%, and Phase IV with 7.4%. Of these trials, 12% are specifically pivotal/registrational, giving an indication that there will be an impact on regulatory approvals in the future.”

GlobalData says cancer trials have been hit the hardest by disruption at 33.3%, followed by central nervous system tests at 16.1%.

Wilson said “there is some hope for clinical trials in these troubled times” given the FDA guidance that allows more siteless tests and other new, virtual ways of setting up and monitoring patients.

Most CROs, which run many trials on behalf of biopharmas, project returning to near-normal levels by the fourth quarter, with other Big Pharmas like Pfizer already back up and running after being hit by the early disruptions of COVID-19 in the spring.