Trials ramping back up, but slow takeup of places remains a barrier: report

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As the pandemic is being beaten back in the U.S. and U.K. (but is still rampant in other areas of the globe), clinical trials are able to get back on track, but slow enrollment is still an issue.

This is according to a report out by life science analytics firm GlobalData, which says: “The surge in new variants for COVID-19 and an increase in subsequent cases is continuing to have an impact on clinical trials, while still allowing them to resume. The total number of disrupted trials has levelled off, but the number of clinical trials that have resumed continues to rise, although somewhat slower than the initial rise.”

The firm said that this implies that companies have “begun to adjust clinical trial design strategies” and evolving to a new post-COVID-19 environment.

“The majority of current trial disruptions are due to trials impacted by slow enrollment, which continue to gradually increase,” said Brooke Wilson, associate director for trials intelligence at GlobalData.

On the plus side, however, Wilson said trials impacted by enrollment suspension as well as delayed initiation “have been on a downward trajectory.”

“This suggests trials that had initiated enrollment before the pandemic with chosen sites and investigators, but then suspended due to COVID-19, are having more success picking up where they left off when enrollment wasn't impacted.”

The firm also points out that, even where trials are fully enrolled, there remains a high risk to subjects in studies who have a serious chronic or acute condition that affects their immune system, giving them a greater chance of contracting COVID-19; this, in turn, is making them unwilling to enroll in a clinical trial.

GlobalData believes some of this can be mitigated by virtual visits, phone interviews, self-administration and remote monitoring. “These suggestions could help trials that are being met with subject quarantine and travel limitations, clinical site closures, and interrupted supply chains, especially trials that delayed initiation and trials that have been impacted by slow enrollment,” it said.

On a more positive note: “The rollout of vaccinations in countries such as the U.K. and U.S. may begin to combat this issue of slow enrollment,” Wilson concludes, though this will not be the case in COVID hot spots such as India and Brazil, which are also struggling to get enough shots into their countries.