COVID-19 disrupted oncology clinical trials. More than a year into the pandemic, drug developers and regulators, including FDA, are also looking for ways to catalyze clinical trial innovation with AI and other tech.

The FDA has been “vigilant as they always are to make sure that there is strong science, but they are much more open both in study design, alternative execution methods and the use of real-world evidence (RWE) and retrospective data,” said Jeff Elton, CEO of ConcertAI.

ConcertAI is now in a five-year collaboration with the FDA that involves RWE and AI to support regulatory decision-making. “One of the first projects is looking at cardiovascular adverse events that occur in [immuno-oncology]-treated patient populations,” Elton said.