FDA issues new decentralized clinical trials guidance

May 3, 2023

The U.S. FDA has released a new draft guidance that provides recommendations for sponsors, investigators and other stakeholders conducting decentralized clinical trials (DCTs).

The new guidance builds on agency recommendations issued in 2020, which provided clarity for investigators to facilitate trial decentralization in response to the COVID-19 public health emergency and associated disruptions.

The guidance defines a DCT as a trial where "some or all of the trial-related activities occur at locations other than traditional clinical trial sites." It addresses hybrid DCTs, where trials involve some in-person visits to traditional clinical sites and some decentralized elements — such as obtaining laboratory tests at a local facility or conducting a follow-up visit in the trial participant’s home using telemedicine.

"By reducing barriers to participation, we expect that DCTs will increase the breadth and diversity of participants in clinical trials and improve accessibility for those with rare diseases or mobility challenges. We anticipate that this approach will facilitate the development of drugs including in areas of medical need, resulting in more treatment options and improved patient outcomes," said the FDA in a statement.

The new draft guidance covers DCT recommendations on:

  • design considerations 
  • conduct of remote clinical trial visits and clinical trial-related activities 
  • use of digital health technologies to remotely acquire data 
  • roles and responsibilities of the sponsor and investigators 
  • obtaining informed consent and institutional review board oversight of the IC process 
  • determination of the appropriateness of investigational products for use
  • packaging and shipping of investigational products 
  • safety monitoring of trial participants 

The agency has issued a 90-day comment period for the draft guidance.