Interpreting the FDA’s 2023 Guidance Impact on Site Enablement Platforms: Considerations for the Conduct of Clinical Trials of Medical Product During Major Disruptions (d/t Disasters and PHEs)

Introduction

In September 2023, the FDA released new guidance that supersedes the COVID-19 pandemic guidance issued in March 2020 along with the updates made to the document issued in August 2021 that impact Site Enablement Platforms.

This guidance aims to assist sponsors, Institutional Review Boards (IRBs), and clinical investigators in conducting clinical trials during disasters and public health emergencies (PHEs). Compliance with this guidance is crucial for ensuring participant safety, data integrity, and trial continuity. The appendix to this guidance provides insight into the current thinking of the FDA through answers to questions that the Agency has received about conducting clinical trials during major disruptions, and how technology available in Site Enablement Platforms can help drive compliance during PHEs.  

We’ve extracted essential insights from the FDA’s guidance:

  • During a PHE the sponsor’s first priority should be whether participants can safely continue in the trial, including necessary modifications and risk mitigation steps to ensure safety.
  • Protocol changes that are required prior to IRB approval to eliminate immediate hazards or to protect the life and well-being of research participants should be reported afterwards. Sponsors and IRBs should proactively work together to define procedures to ensure participant safety and prioritize any deviations necessary due to the PHE. 
  • It is essential for Sponsors, clinical investigators, and IRBs to establish policies and procedures to describe approaches to be used to protect trial participants during PHEs.
  • Sponsor’s should have contingency measures implemented to manage study conduct during disruption of the study as a result of PHEs.

In the appendix, the FDA responded to some critical questions, including the following that relate to use of Site Enablement Platforms during a PHE. 

Q6. Remote Clinical Outcome Assessments (COAs) During Disasters or PHEs

  • Some COAs can be conducted remotely, prioritizing participant safety.
  • Sponsors must consider factors like data quality, technology feasibility, and variability in trial data.

Q12. FDA’s Recommendations for On-site Monitoring During Disasters or PHEs

  • Delays in on-site monitoring are expected during emergencies.
  • Sponsors should adopt alternative approaches like central monitoring and remote tracking.
  • Meticulous documentation of monitoring situations is essential for inspections.

Q15. Electronic Signatures on Clinical Trial Records

  • Electronic systems for signatures must comply with FDA regulations (21 CFR Part 11).
  • While FDA doesn’t certify specific systems, commercial options may offer compliant solutions. (Here’s a link to Demo Florence’s Site Enablement Platform)
  • When unavailable, handwritten signatures or stylus/finger-drawn signatures can be considered, with specific requirements for handling and retention. 

For more compliance information, check out our Florence compliance hub.

Conclusion

FDA’s latest guidance provides invaluable direction for conducting clinical trials in challenging circumstances. By adhering to these guidelines and staying adaptable, we can continue advancing medical research and delivering innovative treatments using Site Enablement Platforms, even amidst disasters like COVID.

For more compliance information, check out our Florence compliance hub.