FDA Updates Guidance for Trials During COVID-19 with Three New Topics
The FDA last week updated its March guidance on managing clinical trials during COVID-19 by saying that sites can conduct patient visits via video conference with some advance planning.
When using video conferencing for patient visits, the guidance recommends putting in place procedures to maintain patients’ privacy, developing an identity verification method so the investigator and patient can confirm their respective identities, and making sure the staff conducting the visit are trained on the use of real-time telemedicine tools.
“Sponsors will likely be relieved that FDA considers real-time video interactions, including telemedicine, as a live exchange of information,” instead of electronic records that would be subject to the agency’s Part 11 regulation, says WCG Clinical Vice President of IRB Compliance David Borasky.
Clinical trials being conducted as a postmarketing requirement may experience delays in reporting to the FDA, the guidance says, and sponsors should inform the agency as soon as possible of any COVID-19-related issues that could cause them to miss interim, completion and/or final report deadlines. Sponsors should provide an explanation of COVID-19’s impact on the timeline and propose a revised schedule for reports.
The guidance also says that if trial participants can’t access the trial site for assessments, it’s permissible to use alternative laboratory or imaging centers if such tests are routinely performed in those settings. However, if the assessments are the basis for formal hypothesis testing, the sponsor should consult with the FDA review division first.
To read the guidance, click here: https://bit.ly/361s91e.