COVID-19 may have dramatically disrupted the clinical research environment – but it hasn’t shut us down. Many ongoing studies are continuing to treat patients virtually, while new trials are beginning to ramp-up. Our recent U.S. survey of how investigators are responding to COVID-19 found that 43% of operating sites plan to enroll new subjects during the pandemic
While the data in our survey is U.S. oriented, it is safe to say that anecdotally in both Europe and Asia-Pac, for instance, we see a very similar pattern emerging from sites in response to this current pandemic. However, the way various regions choose to operate is largely dependent on individual country quarantine mandates.
Although some clinical sites are currently closed, sponsors can leverage this time to begin study start-up activities with remote site staff in order to prepare for study execution when the pandemic restrictions are lifted. The progress made during this timeframe will ensure that sites are prepared for subject recruitment activities, instead of being overwhelmed with requests to launch new trials as fast as possible. If sponsors and sites do not take advantage of this opportunity, sites will be forced to decide which trials they are willing to support as high-demand patient populations will be inundated with requests to participate in trials.
The deluge of requests could delay patient recruitment, stretch site staff, and potentially add months to the ramp-up of new trials. However, sponsors that begin study start-up activities during the pandemic may have a competitive advantage. They can gain an opportunity to connect with high demand patient populations prior to their competitors, and leverage the full focus of furloughed site staff to engage them.
Even if sponsors delay the start of their trials until the restrictions are eased, they will be ready to treat their first patient when sites resume normal operations.
5 tips for recruiting patients
The question now is how do trial teams recruit patients in the midst of a pandemic? Our team at Advanced Clinical offers this advice:
COVID-19 has already added unexpected delays to ongoing clinical research studies. This could eventually cost sponsors millions of dollars and inhibit their ability to bring lifesaving treatments to the market. Using this time to ramp-up study startup activities can minimize the lingering delays that will occur when research begins again. Sponsors have an opportunity to get ahead on their upcoming studies while keeping site staff engaged until the economy reopens.