Revitalizing Psychedelic Clinical Trials: Harnessing Lessons Learned to Drive Operational Excellence & Regulatory Alignment
Time: 9:01 am
day: Workshop Day
Details:
With last year’s FDA rejections and clinical setbacks highlighting inherent challenges of safety, site quality, efficacy, and regulatory alignment, join this workshop to benchmark valuable lessons learned and optimize your clinical trial strategy to successfully bring transformative psychedelic therapies to market.
Highlights Include:
- What is the impact of standalone therapy vs when used in conjunction with psychotherapy? How do we assess these two threads in alignment with what FDA wants to see?
- What is the key to sourcing high quality clinical sites capable of executing psychedelic trials in a timely manner?
- How can we navigate limitations in a clinical site’s ability to handle and safely administer scheduled compounds in line with the protocol?
- What can be done to enhance patient monitoring outside of the clinic and how can patients be effectively informed when it’s time for their next dose?
- How can we apply lessons learned to ultimately aid the commercialization of these compounds? Are there initiatives to diversify trials to generate data more representative of the real world?
