FDA Applauds Role of Clinical Trials in Fighting COVID-19

Courtesy of Centers for Disease Control and Prevention. Credit: Hannah A Bullock; Azaibi Tamin

“Clinical trials are critical” in the battle against the global COVID-19 pandemic, Amy Abernethy, principal deputy commissioner and acting CIO of the U.S. Food and Drug Administration (FDA), told attendees of the Veeva R&D and Quality Summit on Tuesday (October 13).

Meanwhile, though the coronavirus has been a catalyst speeding usage of new tools, technologies, and techniques, time will tell which innovations stick around when the pandemic is just a bad memory, Abernethy said. Acknowledging that COVID-19 has forever changed the clinical trial landscape, she cautioned that the healthcare industry and its regulators will still have to regroup in the future to more accurately determine which innovations truly advanced patient safety and data integrity. “We’re going to have to see what worked” and what didn’t, she said.

Abernethy also touted the value and impact of the new COVID-19 Evidence Accelerator, an initiative launched by the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, to provide a unique venue for major data organizations, government and academic researchers, and health systems to gather and design quick-turnaround queries and share their results.

“We’ve learned a lot of critical information quickly,” in part thanks to the accelerator, Abernethy said. It’s part of the FDA’s overall goal of “ruthless transparency” to “advance innovation” in the fight against COVID-19 and beyond, she added.

It’s time for industry to harness this new spirit and knowledge to find ways to better work together, said Henry Levy, general manager, Vault CDSM, site, and patient solutions at Veeva. “So far, we’ve [as an industry] not done the job well” to advance patient centricity and paperless trials, he said. Sites, sponsors, and the entire clinical trial ecosystem must come together to get the job done, he stressed.

Author: Michael Causey