In a recent GlobalData poll that was completed by readers of Cinical Trials Arena between March 26 and April 2, it was found that 52% of the 527 respondents think it is very likely that there will be clinical trial delays as a result of the coronavirus outbreak. Since early March, upwards of a hundred companies have publically announced disruptions to planned and ongoing clinical trials in their press releases, SEC filings, as well as on social media. Companies have delayed the initiation of planned trials or withdrawn these completely, as well as suspended enrollment in ongoing trials or terminated these trials. The Covid-19 Dashboard on the Pharma Intelligence Center dynamically tracks these disrupted trials from the Clinical Trials Database, along with the list of companies that are the sponsor, collaborator, or contract research organization (CRO).
GlobalData found that the majority of clinical trials, at 67.3%, were disrupted due to the suspension of enrollment, as shown in Figure 1. The delayed initiation of planned trials follows at 18.4%, then, finally, 14.4% of trials are currently being impacted due to slow enrollment. Within the 14.4% of trials affected by slow enrollment, 20.7% of these are specifically due to the availability of sites and investigators. Many hospitals that serve as trial sites are being inundated with Covid-19 patients and are no longer available. For that same reason, many investigators may be repurposed to Covid-19 drug discovery trials or treating COVID-19 patients, or activation of sites for non-COVID-19 trials are being deprioritised. There is also a high risk to subjecs 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.
There are currently 322 companies that are the sponsor, collaborator, or CRO that have reported specific disrupted clinical trials in the public domain, and 179 of these are private or public companies. Just over 50% of these 179 companies are located in the US, followed by the UK at 10.6%, France at 5%, Switzerland at 5%, and Canada at 3.9%. The US is currently at the height of the Covid-19 pandemic, while many European countries experienced high incidence and mortality rates slightly earlier. Boehringer Ingelheim has the highest number of trials that have been specifically reported as disrupted in the public domain by a private or public company, but many other large pharma and biotech such as Pfizer, Eli Lilly, and Bristol-Myers Squibb have announced trial delays.
The majority of disrupted clinical trials are in Phase II, at 44.8%, followed by Phase I with 26.1%, Phase III with 21.7%, and Phase IV with 7.4%. Of these trials, 12% are specifically Pivotal/Registrational, giving an indication that there will be an impact on regulatory approvals in the future. The therapeutic area with the highest number of disrupted clinical trials is Oncology with 33.3%, followed by Central Nervous System at 16.1%, Infectious Disease at 9.3%, Gastrointestinal at 9.1%, and Respiratory at 7.7%. This follows the trend of all clinical trials in general, where number one and two are Oncology and CNS; however, Gastrointestinal usually falls outside the top five at number six and Respiratory currently stands at number eight. This may imply that trials of Respiratory indications outside of Covid-19 trials are more impacted than others due to the high risk of Covid-19.
The FDA has issued guidance for industry, investigators, and institutional review boards conducting clinical trials during the Covid-19 pandemic. Methods that could help keep the research going 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. However, the upward trend for clinical trial delays is expected to continue moving forward, along with a possible shift toward virtual trials.