A surge in new COVID-19 variants and an increase in cases is having a continued impact on clinical trials.
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. 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, says GlobalData.
Brooke Wilson, associate director, Trials Intelligence at GlobalData, comments: “Since June 2020, the number of total disrupted trials has been falling slowly; however, this leveled off in October 2020. The majority of current trial disruptions are due to trials impacted by slow enrollment, which continue to gradually increase. 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.”
As the number of trials that have been impacted by slow enrollment continues to increase, this remains an issue. 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 and making them unwilling to enroll in a clinical trial.
Methods to sustain research
Methods that could help start or sustain research include 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.
Wilson adds: “The rollout of vaccinations in countries such as the UK and US may begin to combat this issue of slow enrollment.”