Update on clinical trials disrupted due to Covid-19

GlobalData Healthcare 14th May 2020 (Last Updated May 14th, 2020 13:57)

Update on clinical trials disrupted due to Covid-19

Since early March, hundreds of companies that are acting as the sponsor, collaborator, or CRO have publically announced disruptions to planned and ongoing clinical trials in their press releases, 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 Companies have delayed the initiation of planned trials or withdrawn these completely, as well as suspended enrollment in ongoing trials or terminated these trials.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 attached to these trials.

GlobalData found that the majority of clinical trials, at 69.9%, were disrupted due to the suspension of enrollment, as shown in Figure 1. Trials currently being impacted due to slow enrollment follows at 17.3%, then finally, 12.8% of trials are due to delayed initiation. Within the 17.3% of trials affected by slow enrollment, 15.4% 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 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.

There are currently 826 organisations that have reported specific disrupted clinical trials in the public domain, more than doubling from the last month when there were 322. Of these 826 organisations, over half (463) are private or public companies, with just over 50% located in the US, followed by the UK at 8.2%, France at 5%, Switzerland at 3.7%, and Canada at 3.2%. The US is currently starting to see the number of new Covid-19 cases and deaths begin to slow, while many European countries experienced high incidence and mortality rates slightly earlier. Boehringer Ingelheim still has the highest number of trials that have been specifically reported as disrupted in the public domain by a private or public company, followed by Eli Lilly, Shire, Novartis, and UCB. The Sarah Cannon Research Institute is the CRO that has reported the highest number of disrupted clinical trials, followed by IQVIA, Pharmaceutical Product Development, Covance, and PRA Health Sciences.

The number of disrupted clinical trials has almost doubled in the last month to over 1,100, with the majority in Phase II, at 43% (44.8% last month), followed by Phase III with 24.5% (21.7%), Phase I with 22.6% (26.1%), and Phase IV with 9.8% (7.4%). Of these trials, 12.4% (12% last month) 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 31.2% (33.3% last month), followed by Central Nervous System at 17.5% (16.1%), Gastrointestinal at 8.5% (9.1%), Infectious Disease at 8.1% (9.3%), and Cardiovascular at 8.1% (not in the top five last month). 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. Inflammatory Bowel Disease is the highest indication within this therapy area, which is often treated with immune suppressant drugs like TNF inhibitors, so this may imply that trials with Gastrointestinal indications outside of Covid-19 trials are more impacted than others due to the high risk of Covid-19 to patients with a lowered immune system.

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 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. There are also now over 60 trials that were previously disrupted from the Covid-19 pandemic by delayed initiation and slow or suspended enrollment that is now ongoing or completed. The upward trend for clinical trial delays may begin to slow-moving forward as more companies adjust, along with a possible shift toward virtual trials.