Psychedelic research is rapidly expanding, offering exciting opportunities for studying novel treatments for mental health conditions. However, launching a research program in this space comes with unique challenges, from regulatory hurdles to ethical considerations.
This article provides practical recommendations for researchers looking to establish and conduct psychedelic studies. Key topics covered include:
- Regulatory and Compliance Hurdles – Navigating FDA regulations, DEA licensing, and Institutional Review Board (IRB) approval processes
- Institutional Support & Infrastructure – Strategies for securing funding, training staff, and ensuring interdisciplinary collaboration
- Ethical and Safety Considerations – Addressing risks, patient screening, and safety monitoring protocols
- Future Directions – How to establish sustainable and successful psychedelic research programs and contribute to the growing field of psychedelic medicine
Whether you are new to psychedelic research or looking to refine your approach, this article offers practical insights to help you successfully navigate the complexities of the field.
Read the full article here: Practical considerations in the establishment of psychedelic research programs | Psychopharmacology
Marcus Delatte, PhD
VP, Regulatory Strategy, Regulatory & Drug Development Consulting
Dr. Delatte served as a Senior Pharmacology/Toxicology Reviewer at the US FDA for 12 years. He is an established expert in translating nonclinical data to inform clinical program design, including dose selection, safety monitoring, inclusion/exclusion criteria for clinical protocols, and informed consent forms. Dr. Delatte has extensive experience in creating and implementing strategies for regulatory pathways in the US, as well as preparing and creating strategies for formal FDA meetings. His expertise and experience span multiple therapeutic areas including psychiatry, neurology, pain, rheumatology, infectious disease, immunology, cardiovascular, pulmonary, and oncology.
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