Since early last March, around 1,000 organisations supporting clinical trials as a sponsor, collaborator or contract research organisation (CRO) have announced disruptions to planned and ongoing clinical trials. Companies have delayed the initiation of planned trials or withdrawn them completely, have suspended enrolment in ongoing trials, or have terminated these trials. GlobalData tracks these disrupted trials and organisations, along with trials that have resumed activity since disruption.
Since last June, the number of total disrupted trials has been falling slowly, as shown in Figure 1, but this levelled off in October. Most disruptions are caused by slow enrolment. Trials impacted by enrolment suspension as well as delayed initiation have been falling. This suggests trials that had initiated enrolment before the pandemic with chosen sites and investigators, but were then suspended due to Covid-19, are having more success picking up where they left off when enrolment wasn’t impacted.
Many hospitals that serve as trial sites were inundated with Covid-19 patients and may still not be available; likewise, many investigators may have been reassigned to Covid-19 drug discovery trials or treating Covid-19 patients while the activation of sites for non-Covid-19 trials is being deprioritised. 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 enrol in a clinical trial. The rollout of vaccinations in countries such as the UK and US may begin to combat this issue.
The US Food and Drug Administration (FDA) has issued guidance for industry, investigators and institutional review boards on conducting clinical trials during the pandemic. 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 enrolment.
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The total number of disrupted trials has leveled off but the number of clinical trials that have resumed continues to rise, although somewhat slower than the initial climb (see Figure 2). This implies that although sponsors and contract service providers have begun to adjust clinical trial design strategies and are adapting to the new post-Covid-19 environment, the surge of the new variants and subsequent cases is having an impact.