Trial disruption easing, but fallout will linger: report

As CROs and biopharmas adapt to virtual trials and conducting tests amid a pandemic, some studies are back up and running, but future approvals will be hit by last quarter’s chaos.

This is according to a report from life science analysts at GlobalData, which found more than 200 trials that had been hit by the COVID-19 pandemic—specifically by a delayed start and slow or suspended enrollment—are now ongoing or completed.

“This represents a 3.2-times increase compared to last month,” the firm said, adding: “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.”

But it warns not to crack open the champagne just yet. Brooke Wilson, associate director of trials intelligence at GlobalData, said: “The number of disrupted clinical trials and organizations has continued to grow over the last three months. This trend is most noticeable between April and May.”

She added that while this is now easing off, “Over all three months, 14% of the disrupted clinical trials are specifically pivotal/registrational, giving an indication that there will be an impact on regulatory approvals in the future.”

In the U.S., some states are still battling to control the spread of the virus and some are lifting more lockdown restrictions. Wilson says that while the virus is still in communities and hospitals, this will pose a big issue for trials that are required to be undertaken in secondary care settings.

“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 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.”

But the use of virtual or siteless trials, where they can be undertaken, is helping some studies back into the fore. Wilson says: “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.”