Since early March, around 1,000 organisations supporting clinical trials as a sponsor, collaborator, or contract research organisation (CRO) have publicly announced disruptions to planned and ongoing clinical trials in their press releases, Securities and Exchange Commission (SEC) filings, and clinical trial registries, as well as on social media. Companies have delayed the initiation of planned trials or withdrawn them completely, have suspended enrolment in ongoing trials, or have terminated these trials. GlobalData dynamically tracks these disrupted trials and organisations, along with trials that have resumed activity since disruption.
Since June, the number of total disrupted trials has been falling slowly, as shown in Figure 1. The majority of current trial disruptions are still due to the suspension of enrolment, although trials impacted due to slow enrolment are increasing
and only trials that suspended enrolment have been on a downward trajectory. Clinical trials that delayed initiation have remained steady and trials that have been impacted by slow enrolment have continued to increase. This suggests trials that had initiated enrolment 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 enrolment wasn’t impacted.
Within the category of trials currently affected by slow enrolment, one-tenth of these are specifically due to the unavailability of sites and investigators. 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 of treating Covid-19 patients and the activation of sites for non-Covid-19 trials is being deprioritised. As the number of trials that have been impacted by slow enrolment continues to increase, this seems to continue to be 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 enrol in a clinical trial.
The overwhelming majority of trial sites that are currently disrupted are located in the US, at 44.5%. This is followed by the UK at 7.6% of all sites and Spain at 5.4%. The highest numbers of site disruptions in the US are found in California at 10.2%, followed by Florida at 9.6%, Texas at 8.9%, and New York at 5.9%.
The FDA has issued guidance for industry, investigators, and institutional review boards on conducting clinical trials during the Covid-19 pandemic. Methods that could help keep the research going or get started 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. Importantly, the total number of disrupted trials is falling and the number of clinical trials that have resumed continues to rise (Figure 2). 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.