Applied Clinical Trials
Since early March, over a hundred companies have publicly 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 Companies have delayed the initiation of planned trials or withdrawn these completely, as well as suspended enrolment in ongoing trials or terminated these trials.
GlobalData, a data and analytics company, found that the majority of disrupted clinical trials 67.3%, were due to the suspension of enrollment. 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.
Brooke Wilson, Associate Director, Trials Intelligence at GlobalData, comments, “Non-COVID-19 trials are being delayed or deprioritized, and clinical trials for respiratory indications may be further impacted. 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, whilst the activation of sites for non-COVID-19 trials are being deprioritized. 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.”
GlobalData also found that there are currently 322 companies that are the sponsor, collaborator, or CRO reporting specific disruption to 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 U.S., followed by the UK at 10.6%, France at 5%, Switzerland at 5%, and Canada at 3.9%.
Wilson comments, “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.”
In terms of indication, oncology has the highest number of disrupted clinical trials with 33.3%, followed by Central Nervous System (CNS) at 16.1%, Infectious Disease at 9.3%, Gastrointestinal at 9.1%, and Respiratory at 7.7%. However, it appears that trials of respiratory indications outside of COVID-19 trials are more impacted than others due to the high risk of COVID-19.
Wilson adds, “Guidance from the Food and Drug Administration (FDA) has been issued with suggestions on how to continue research-researchers can use virtual visits, phone interviews, self-administration, and remote monitoring to work around quarantine, travel restrictions, and site closures, so there is some hope for clinical trials in these troubled times”