FDA Back to Work; Gottlieb Announces New Clinical Trial Plan

January 28, 2019

On the first day back to work after the record-breaking government shutdown, FDA Commissioner Scott Gottlieb announced new plans to explore the use of digital technologies that bring trials to patients and increase access to real-world evidence.

He said Monday that the agency has established a formal working group on decentralized trials and is now developing a guidance document.

Improving trial access, Gottlieb said, can generate a more diverse patient population and help investigators collect data that better reflects the real world.

“By working collaboratively with the clinical trial community and patient groups, we can develop scientific and technical standards for incorporating new technologies into clinical trials to make them more agile and accessible to patients and regulators,” Gottlieb said.

Also on Monday, CDER Director Janet Woodcock briefed newly returned staff on plans and priorities for catching up with business that was postponed over the past six weeks.

“Every firm with an issue pending before us will be asking for a timeframe, and the trade press and others will be asking for estimates,” Woodcock said.

“We always try to be helpful to outside stakeholders, but in this case, we need to make collective decisions, so please do not give out estimates. Over the next few days, as we sort through what is pending, we will make plans and disseminate them, so we will all be working from the same playbook, she added.”

How long that playbook will be active is uncertain, however. The stopgap funding bill signed on Friday will keep the government open for only three weeks while Congress and the White House work to resolve their differences on immigration reform. Temporary funding provided by the bill will run out on Feb. 15.