In early March 2020, Clinical Research IO conducted a clinical trial industry survey and found that COVID-19 is disrupting clinical research operations at all 73 participating sites. As the situation continues to evolve, sites are forced to constantly adapt. The majority have halted new patient enrollment for ongoing studies but will continue to conduct visits for subjects already randomized.
We are relying on virtual visits, meaning phone calls, to collect data like adverse events, concomitant medications and questionnaires.
– David Rodin, Chief Executive Officer at Amici Clinical Research.
“When possible, we have requested that patients perform some procedures on their own, such as blood pressure, temperature, and vitals, and record a comment in the source indicating it was done by the patient with a note of how it was done e.g. temperature taken by a patient with an oral digital thermometer.” Mr. Rodin advised that while this system is not perfect, data can still be collected and may help highlight a clinically significant finding.
Sarah Ruiz, Regulatory and Finance Manager at A Premier Medical Research said, “phone calls are being utilized to ensure that patients still have an investigational product, but standard procedures for the majority of visits such as blood draws and physical exams are unable to be performed as it increases the risk of exposure.”
While many have turned to virtual and phone visits, several sites indicated that they are performing home visits.
“Our site recently completed four home visits,” said Elisa Betancourt, President of TRC Clinical Trials. “For each home visit, the principal investigator, a medical assistant and sometimes myself will be present. We check site staff and the patient for any symptoms and assess risk prior to the visit. We wear masks and gloves for protection but perform study procedures including blood draws and EKGs. We bring all equipment with us.”
Betancourt then explained that despite visits being fully completed according to study timelines, protocols do not permit home visits. Her site will likely receive protocol deviations unless sponsors obtain permission from IRBs.
Regardless of whether research sites have transitioned to virtual or home visits, sites have noted an increase in workload.
COVID has pushed research sites to change the following:
- Implement COVID screening measures such as phone interviews and/or fever checks
- Travel to patient homes
- Create enhanced IP handling procedures including home delivery, temperature monitoring in different environments, more complex accountability, and IP kit cleaning
- Create or adapt protocol procedures for home testing (e.g. urine pregnancy tests)
- Adopt new technology platforms such as eSource or eRegulatory to enable remote monitoring
- Scan & upload source or regulatory documents for remote monitoring
- File more protocol deviations due to COVID-related adjustments
Ruiz elaborated on how her site is managing IP. As her site has an SOP that requires two site members to verify IP kits before dispensation, this process has been shifted to the phone. Site staff must send pictures or call via facetime before delivery.
TRC clinical trials implemented a protocol for monitoring the temperature of IP during delivery. Bentancourt explained, “After IP is dispensed on-site, the temperature of the IP will be measured before leaving the site, during transport, and upon arrival to the patient’s home. The temperature of the patient’s home will also be documented.”
Rodin advised that “The biggest source of extra work is likely preparing for upcoming remote monitoring visits. Without an eRegulatory system in place, our site will have to pull a lot of paperwork and then scan, email, or fax each document.”
With fewer patients being seen due to enrollment holds, and study procedures involving significantly more work and time, sites are still incurring costs.
ClinEdge recently released a webinar whose panelists advised that managing site compensation during the pandemic will be one of the biggest challenges. So far, sites have reported that few sponsors have provided guidance on this matter and are concerned about the financial sustainability of these enhanced SOPs. Sponsors should be prepared for requests to amend clinical trial agreements (e.g. releasing holdback fees, establishing procedure level costs, providing compensation for remote monitoring visits) and be flexible during and after the pandemic.