Changes To Study Visits And Assessments During COVID-19: Subject Safety Considerations

By Monica Frazier, Jamie Chang, and Jack Modell

The COVID-19 pandemic has understandably generated a surge of concern among clinical researchers about how best to minimize the risk to study subjects of exposure to COVID-19 while also preserving study integrity and a favorable risk-benefit of study participation for subjects. In general, research principles don’t change because the world is going through a public health crisis, and the principles of Good Clinical Practice, risk-benefit, subject safety, and ethics remain as fundamental priorities of clinical research. However, we can shed some light on specific topics that might be considered during this time, which are also approached in the recent April 2020 update to the FDA Guidance on Conduct of Clinical Trials of Medical Products during the Covid-19 Pandemic.

It is critical during the COVID-19 pandemic that sponsors consider each clinical trial circumstance specifically, including potential unique or increased risks associated with continued study conduct, taking into consideration the nature of the investigational product (IP), the appropriateness and feasibility of continued or changed safety monitoring, supply chain limitations, and the nature of the disease under study. Any changes made to the study plans should be communicated to subjects and study institutional review boards (IRBs) as soon as possible and documented appropriately via protocol amendments and the clinical study report.