Since early March, around 1,000 organisations supporting clinical trials as the 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 Companies have delayed the initiation of planned trials or withdrawn these completely, as well as suspended enrolment in ongoing trials or terminated these trials. GlobalData dynamically tracks these disrupted trials and organisations, along with trials that have resumed activity since disruption.
The overwhelming majority of trial sites that are currently disrupted are located in the US, at 42.4%. This is followed by the UK at 7.2% of all sites and Spain at 4.7%. The US is currently seeing the highest number of confirmed Covid-19 cases since the pandemic began to spike in certain states such as Florida, California, Arizona, and Texas. The highest numbers of site disruptions are found in California at 10.8%, followed by Florida at 10.3% and Texas at 9.5%. New York comes in fourth at 6.1%, where the pandemic initially hit the hardest.
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 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.