A COVID-19 rapid response plan that helped one pharma company restart all of its paused studies worldwide by mid-July can serve as a model for other drugmakers trying to recover from the pandemic.
Otsuka Pharmaceutical ordered its 800-plus active testing sites around the world to halt new screening activity three weeks into the crisis and rolled out a restart plan about a month later, says Corey Fowler, director of global clinical development for the Japanese drug manufacturer. As a result, testing has resumed at 95 percent of sites.
The company was able to transition from only face-to-face visits at the beginning of March to conducting all visits virtually by April 9. And on May 6, Otsuka began allowing some sites to return to face-to-face visits.
“In parallel, the operations and the management teams started working with our CRO partners on site visit guides that were specific to each protocol’s scheduled assessments,” Fowler said, speaking at a WCG Clinical webinar last week. “These were instructions that would not only align with the FDA guidance (on conducting clinical trials during the pandemic), but we developed them a la carte per scheduled assessment to ensure subjects were safe and that we were able to collect the data in a way that would be allowed.”
Fowler said Otsuka “had to negotiate, essentially assessment by assessment, for some psychiatric assessments to gain alignment.” He added that the company worked with CROs to modify its existing eSource program to differentiate between data collected virtually vs. in-person, an approach in keeping with FDA recommendations that could be replicated industrywide.
The company was able to start recording COVID-19-related protocol deviations in its eSource system within three weeks and developed an electronic system for recording patient-reported outcomes that it was able to implement by the beginning of June.