Demands for Increased Evidence Generation Fuel Hybrid Trial Approach

Amy Abernethy

Amy Abernethy, MD, PhD, President of Verily Life Sciences’ Clinical Studies Platforms

The COVID-19 pandemic accelerated the demand for continuous evidence generation to power precision health approaches in clinical trials, says Amy Abernethy, MD, PhD, president of Verily Life Sciences’ Clinical Studies Platforms and former Principal Deputy Commissioner and Acting Chief Information Officer at the U.S. Food and Drug Administration.

As a result, clinical research professionals will “need to be more patient-centric, and study sites need to be empowered” to help make it happen, Abernethy says. The trend will also require longer term engagements with patients, which in turn will fuel the uptick in hybrid models of onsite/offsite trials “to meet patients where they are,” she adds.

“At Verily, we believe that a shift toward precision health will make better health possible for everyone. This means a move toward care that is more personalized, patient-centered, and accessible,” Abernethy says.

“Our focus in the clinical research business is on generating the data and evidence needed to understand whether promising treatments and technologies work and, specifically, which patients will benefit from them,” Abernethy notes.

“We are doing this by building tools and solutions that improve the research experience for participants, study sites, and sponsors alike, and that enable the collection of longitudinal datasets that reflect broader and more diverse patient populations,” she continues. “ACRP members, many of whom are clinical research professionals on the front lines, play an essential role in helping achieve this vision for precision health.”

She’s excited by new opportunities to leverage technology to “run more efficient studies and support” the shift toward continuous evidence generation in trials. “Clinical evidence generation of the future [done properly could mean] earlier approval with better continuous data” in clinical trials, Abernethy says.

Author: Michael Causey