FDA, EMA Update COVID-19 Guidance for Clinical Trial Continuity

The impact of COVID-19 on non-related clinical trials is complex and poses significant challenges for sponsors, investigators, monitors and patients. With the scale of disruptions (e.g. self-isolation, travel bans) as well as the implications of social distancing, regulators are providing guidance to steer decisions that protect patient safety and preserve data integrity.

Given the volatility of the situation, both the FDA and the European Medicines Agency (EMA) in conjunction with working groups from the European Commission and the national Heads of Medicines Agency (HMA) issued revised guidance from their original recommendations in late March.

In particular, the FDA included a set of questions and answers that cover a wide variety of topics including:

• Factors sponsors should use in deciding whether to suspend or continue ongoing studies and/or initiate a new study
• Alternative means of distribution of investigational products.
• Considerations in selecting alternative laboratories or imaging centers.
• Remote monitoring and applying a risk-based approach to prioritize sites for remote monitoring.
• Usage of video conferencing between study personnel and patients.

FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency

The FDA released updated guidance on May 14, 2020 for sponsors, investigators and institutional review boards as to whether they should continue ongoing clinical trials during this pandemic. The new document includes a useful FAQ section at the end.

View the full document.

European Commission Publishes Further Guidance on Clinical Trial Conduct During COVID-19 Pandemic

The European Commission published updates to its guidance at the end of April 2020 to ensure the utmost safety and well-being of trial participants across the EU while preserving the quality of the data generated by the trials.

View the full document.