“Whatever we could do to make it easier for patients, we’ve tried,” said Patrick Floody, Senior Director for Global Trial Strategy and Optimization at Regeneron, reminding attendees of the ACRP 2021 virtual conference on May 27th how his organization helped support three COVID-19 clinical trials last year with lightning-fast and effective results.
“We were able to activate websites about 80% faster than usual,” said Floody.
During the pandemic, Regeneron did the following:
- A study of 92 locations showed an average of 48 days to activate the location.
- Another study with 92 sites achieved the same thing in an average of 34 days.
- In a study of 103 locations, an average of 39 days were recorded until the location was activated.
According to Floody, on-site training was conducted online and in virtual sessions using a learning management system. The effective use of home health visits is also an important tool that will add 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 used,” he said.
James Riddle, vice president of institutional services at Advarra, highlighted the benefits of exciting new technologies available in clinical trials and emphasized that people and processes, in that order, are the ultimate foundation for effective trials. He also noted the importance of having a clear vision of an end goal and securing executive buy-in before attempting a new technology initiative.
The COVID-19 pandemic “gave everyone [clinical trial] Stakeholders 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 of the changes initiated during the pandemic, such as the increased use of decentralized clinical trials, will stay here.
“COVID-19 has led us to identify ways in which you can use your own device (BYOD) as the standard data collection tool for evaluating clinical outcomes,” Floody said. “BYOD is the wave of the future and we will need new apps,” he added.
The next round of ACRP 2021 meetings in September will focus on regulatory trends and compliance issues.
Author: Michael Causey