Changes to Study Visits and Assessments During COVID-19: Subject Safety Considerations

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. 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.