COVID-19 Trial Changes Are “Propulsive Force” For Digital Adoption

BY COLE WERBLE

Executive Summary

Robert Califf, a former FDA commissioner turned Verily Life Sciences exec, is just one of the voice predicting a long-term impact on clinical trial processes from the COVID-19 outbreak.

Current and former US Food and Drug Administration officials are expressing broad agreement that COVID-19 will likely be a prod to the wider-ranging acceptance of digital health information from clinical trials.

The practical difficulties of collecting information at specific sites during the mobility restriction of the SARS-CoV2 pandemic are acting as a catalyst for mobile collection technologies. The agency has made that point in a formal way in its initial guidance for sponsors on how to address issues raised by the outbreak in the context of clinical trials for other products. That guidance noted numerous times that “alternative methods” may need to be considered for monitoring sites, such as “virtual visits.” (Also see “US FDA Offers More Advice On MidTrial Changes For Pandemic-Impacted Studies” - Pink Sheet, 30 Mar, 2020.)

The idea that the COVID-19 pandemic will accelerate the use of digital health in clinical trials also has been expressed by several top agency officials, starting with FDA principal deputy commissioner Amy Abernethy.

“In this landscape of COVID-19 we are talking more and more” about digital health “to support our clinical trials structure and distributed clinicals trials,” Abernethy told a March 24 National Academies teleconference on digital health technologies in drug development. “This is a critical place the story is going.”

Center for Drug Evaluation and Research director Janet Woodcock sees a short-term move to more virtual clinical assessments as inevitable, and predicts a longer term impact. That change will be “a very positive thing in general,” Woodcock said during a recent interview. (Also see “CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’” - Pink Sheet, 31 Mar, 2020.)

And that view has been echoed by former top FDA officials as well. Former commissioner Robert Califf (Verily Life Sciences) began the NASEM meeting by calling the FDA guidance on clinical trials during COVID-19 “a special propulsive force to get moving on digital technologies.” Leonard Sacks, from the Office of Medical Policy in the Center for Drug Evaluation & Research, agreed with that sentiment, and told the NASEM teleconference that the ability of digital health to collect data remotely is important to decentralized clinical trials and “very pertinent today to the calamity that we face.”

Califf’s successor at the FDA, Scott Gottlieb, has also agreed that the coronavirus outbreak is likely to bring broader adoption of “de-centralized” clinical trial techniques. ( (Also see “US FDA Outlines Wishlist For Decentralized Clinical Trials” - Pink Sheet, 13 Mar, 2020.))

Like so much about the COVID-19 pandemic, the adoption of “virtual” trial models may be a case of preparing after the pandemic with steps that business leaders and policy makers will wish they had adopted before – as many ongoing studies may be hopelessly compromised by the inability to follow the planned study procedures amid the outbreak.

And the need to salvage clinical studies will not be itself resolve all the barriers to broader use of digital technology, including the clash of cultures and terminologies that can inhibit the effort. (Also see “Digital Doublespeak: The Language Barrier When Tech Companies Meet Regulators” - Pink Sheet, 9 Apr, 2020.)