There has been an increase in clinical trial delays due to concerns for patient and investigator safety, travel restrictions, subject quarantine, clinical site closures and interrupted supply chains. Numerous aspects of clinical trials are being impacted including enrolment of patients, study start times and initiation of new studies, says GlobalData, a leading data and analytics company.
Brooke Wilson, Associate Director, Clinical Trials at GlobalData, comments: “Shut-downs and quarantines in the US and other countries appears to be contributing to worldwide disruptions in the clinical trial supply chain. In the US, up to 80% of active pharmaceutical ingredients are sourced globally, where China and India play critical roles.
“Many clinical trial sites at hospitals are likely to be inundated with COVID-19 patients, which will also play an increasing part in trial delays. With fewer trial sites and investigators available to the run the trials, clinical trials for other indications will be deprioritized.
“There may be some fear in potential patients enrolling in trials in a clinical setting due to a perceived elevated risk of contracting COVID-19. This recent pattern of trial start delays is expected to continue and worsen. There may also be an increase in withdrawn trials as some sponsors pull the plug completely.”
Guidance has been issued by the US Food and Drug Admiistration (FDA) for the industry, investigators and institutional review boards conducting clinical trials during the COVID-19 pandemic. Research could be kept going using alternative methods. For example, virtual visits, phone interviews, self-administration, and remote monitoring could help deal with issues impacting clinical trials.
Wilson concludes: “The upward trend for clinical trial delays is expected to continue moving forward. In order for clinical trials to achieve their end points during COVID-19, companies will have to adapt to disruptions and reprioritize their goals.”