It was a tough three months for clinical trials as they were hit by lockdowns, but, as many CROs predicted, things are starting to ease up.
According to analysis by life science data firm Global Data, the number of disrupted trials “began to fall between June and July,” mostly due to the suspension of enrollment followed by slow enrollment and delayed initiation.
Although this is good news, there are still pockets of disruption.
Brooke Wilson, associate director for trials intelligence at GlobalData, combed through her firm’s data and found: “Although the total number of disrupted trials is decreasing overall, of trials that listed disruption as suspension of enrollment, slow enrollment or delayed initiation as their reason for disruption, only those affected by suspended enrollment have reduced (by 17.3%) compared to last month.
“Meanwhile, trials with delayed initiation have risen by 10% and trials that have been impacted by slow enrollment have gone up by 13.9%. This suggests that trials that had already 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 as long as enrollment wasn't impacted.”
GlobalData says that when it comes to slow enrollment causes, about 10% are “specifically due to the availability of sites and investigators,” notably because trial sites in hospitals are “overwhelmed with COVID-19 patients, repurposed investigators, deprioritized non-COVID-19 trials, and high-risk subjects unwilling to enroll due to a greater chance of contracting COVID-19.”
Wilson added: “Importantly, the total number of disrupted trials is falling and the number of clinical trials that have resumed has almost doubled since last month. This implies that sponsors and contract service providers have begun to adjust clinical trial design strategies and are adapting to the new post-COVID-19 environment.”But there are still concerns around the world about a potential second wave, especially in the winter when it could work in tandem with flu season and cause even greater disruption. There are also still growing cases, notably in the U.S. and across some countries in South America, meaning the first waves in these regions are still yet to be brought fully under control.