May 15, 2020
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:
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.
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.