“Whatever we could do to make it easier for patients, we tried to do,” Patrick Floody, senior director of global study strategy and optimization at Regeneron, told attendees of the ACRP 2021 virtual conference on May 27, recalling how his organization helped support three COVID-19 clinical trials last year with lightning speed and efficacy.
“We were able to activate sites about 80% faster than usual,” Floody said.
During the pandemic, Regeneron accomplished such feats as these:
- A 92-site study posted an average of 48 days to site activation.
- Another 92-site study accomplished the same in an average of 34 days.
- A 103-site study recorded an average of 39 days to site activation.
Site training was conducted online and through virtual sessions using a learning management system, Floody said. Utilizing home health visits effectively was also a vital tool that contributed to their ultimate success, he added. Home health visits will continue to play a key role in future clinical trials, and the “industry needs to better define how it will be employed,” he said.
Even while extoling the virtues of exciting new technologies available in clinical trials, James Riddle, vice president of institutional services at Advarra, stressed that people and process, in that order, are the ultimate foundation of effective trials. He also noted it is critical to have a clear vision of an end goal, and to secure executive buy-in before attempting to launch a new technology initiative.
The COVID-19 pandemic “gave every [clinical trial] stakeholder a reason to experiment with alternative solutions for all clinical operations,” said D’Anna Siegle, senior product manager at Florence Healthcare. She agreed with other speakers that many changes ushered in during the pandemic, such as increased use of decentralized clinical trials, are here to stay.
“COVID-19 has caused us to identify ways of placing bring your own device (BYOD) as the standard data collection tool for” clinical outcome assessments, Floody said. “BYOD is the wave of the future, and we’re going to need new apps” to accommodate it, he added.
The next round of ACRP 2021 sessions, coming up in September, will focus on regulatory trends and compliance topics.
Author: Michael Causey
