The increased utility of Chinese herbal formulations worldwide during the pandemic has spotlighted the use of herbal botanicals for treatment of Covid-19. The need for clinical trials is more important than ever to affect changes in health policy to encourage integration of herbal formulations into conventional care and insurance coverage. Understanding the role in clinical trials of relationship building, developing common goals and objectives, partnering, funding, and integrating with established biomedical research structure, methodology, and language is crucial. This talk will address special considerations regarding Chinese herbal botanicals in clinical trials conducted in the US, including a general overview of getting FDA approval for an Investigational New Drug (IND) study and addressing concerns about safety.