January 29, 2021

The COVID-19 pandemic is the first natural disaster that the world has faced since the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) formulated guidelines in 2008 for Good Clinical Practice (GCP) in conducting clinical trials. We have never faced a situation like the one we are facing today.

 

In order to ensure human safety and the appropriate conduct of trials, it has been necessary to temporarily relax clinical trial protocols. This has caused major disruptions for how Ophthalmology clinical trials are conducted. This is especially true for studies of the retina, which, per the protocol, typically require active intervention via regular visits to sites, followed by safety assessments performed by the Principal Investigator.

 

This white paper examines the principles and procedures which were applied to a clinical trial for wet age-related macular degeneration (AMD) during the COVID-19 pandemic, from changes in patient screening to updating how study visits are conducted to new methods for monitoring. Many of these decisions can serve as guideposts for those sponsoring other Ophthalmology trials during this or similar crises.