UK Regulatory Authority Issues Guidance on Managing Trials During Outbreak

Image courtesy of Centers for Disease Control. Credit: Alissa Eckert, MS; Dan Higgins, MAMS

The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) today (March 19) published a guidance on “Managing clinical trials during Coronavirus (COVID-19)” to advise those involved in clinical trials on specific issues which may arise as a result of the current pandemic, and what they are required to do.

According to the agency, “The MHRA will be as flexible and pragmatic as possible with regard to regulatory requirements for clinical trials during this time. We recognize that clinical trial resources may be absent or redeployed from research activities and regulatory affairs towards front-line care. The first priority should be the safety of trial participants and this will remain our focus.”

The guidance will be updated as the situation changes over time, MHRA added. MHRA had earlier issued a directive (March 12) noting it was “aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials.” The directive addresses the possibility of increased protocol deviations in studies under current conditions, how study tactics involving less direct contact with patients might be useful, and other special considerations.

Edited by Gary Cramer