Key MedDRA Coding Gaps Highlighted at the ISCTM 2025 Scientific Meeting

At the 21st Annual Scientific Meeting of the International Society for CNS Clinical Trials and Methodology (ISCTM) in Washington, DC, earlier this year, MMS Senior Director of Regulatory Strategy Dr. Amanda Beaster presented a poster addressing a growing issue in psychedelic drug development: the underreporting of psychoactive effects due to gaps in MedDRA coding practices. 

These effects, such as exaggerated well-being, mood elevation, or laughter, may not be viewed as adverse events by Sponsors or investigators. However, they can reflect signals relevant to abuse potential or participant vulnerability. The FDA’s 2017 guidance on assessing abuse potential advises Sponsors to collect events that may offer abuse-related insights, using examples of MedDRA Preferred Terms (PTs).  

Yet many stakeholders misunderstand the MedDRA coding process.  

In practice, investigators report verbatim terms, which are coded to MedDRA Lowest Level Terms (LLTs) that then map to PTs. Without clarity on this process, key signals may go unrecognized. 

Dr. Beaster first identified this issue while supporting a Sponsor’s NDA, later confirming its broader impact through published psychedelic studies. At ISCTM, she shared these findings and participated in discussions with regulatory and industry leaders, including working groups on abuse potential and novel endpoints for CNS-active drugs. Additionally, Dr. Beaster took part in conversations with FDA Deputy Center Director Dr. Marta Sokolowska on the lack of platform trials in this space and the potential role of Emergency Use Authorizations. 

As psychedelic and CNS drug development continues to grow, MMS remains focused on helping Sponsors navigate this complex and evolving landscape with accurate safety reporting, informed coding practices, and regulatory strategy that supports long-term success. 

Email info@mmsholdings.com to pose questions to Dr. Beaster.