COVID-19 disruption of clinical trials starting to slow: GlobalData
FDA issued guidance recommends methods that could help keep the research going which includes virtual visits, phone interviews, self-administration, and remote monitoring
More than 200 trials that were previously disrupted from the COVID-19 pandemic by delayed initiation and slow or suspended enrollment are now ongoing or completed. This represents a 3.2-times increase compared to last month. This upward trend for clinical trial delays may begin to slow further as more companies adjust to conducting clinical trials during COVID-19, along with a possible shift toward virtual trials, says GlobalData, a data and analytics company.
Brooke Wilson, Associate Director, Trials Intelligence at GlobalData, comments, “The number of disrupted clinical trials and organisations has continued to grow over the last three months. This trend is most noticeable between April and May but has begun to slow, as depicted in the figure. Suspension of enrollment accounted for 61.5 per cent of the disruptions. Over three months, 14 per cent of the disrupted clinical trials are specifically Pivotal/Registrational, giving an indication that there will be an impact on regulatory approvals in the future.”
Wilson continues, “Many hospitals that serve as trial sites were 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 serious chronic or acute condition that affects their immune system, giving them a greater chance of contracting COVID-19.”
“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,” he added.
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