Karen Luong, Kimberly Chew and Natasha Sumner will present, "Psychedelics & Clinical Trials: Site Feasibility and Audit Preparedness," at the Psychedelic Therapeutics and Drug Development Conference on Sunday, May 14, 2023.
FDA-approved clinical trials are critically important for psychedelics to become accepted and recognized as substances with approved medical use. Psychedelics such as MDMA and psilocybin are approaching federal regulatory approval for use to treat depression, anxiety, and a variety of substance use disorders. Many innovators and scientists are interested in running clinical trials in order to prove safety and efficacy and as a necessary step to eventual commercialization. The speakers will provide an overview of current psychedelic clinical trials for certain mental health and behavioral health treatments, outline some of the requirements for clinical site feasibility, licensing requirements that sponsors will need to bear in mind when choosing a clinical trial site, the challenges of running and operating clinical trials for Schedule I drugs, and areas of concern in order to be prepared for a clinical site audit.
For more information, visit the event website.