Well-being as a primary endpoint in clinical trials: a call for consensus.

Authors

Elliot Marseille, Hannes Kettner, Tyrone J Sgambati, James G Kahn, Stefano Bertozzi, Will Lucas, Robin Carhart Harris, Dacher Keltner, Charles Raison

Published in

Npj mental health research. Volume 5. Issue 1. Aug 06, 2026. Epub Aug 06, 2026.

Abstract

Psychiatric trials typically define success as symptom reduction, yet patients prioritize meaning, vitality, and functioning. This imbalance undervalues experiential benefits, distorting clinical, policy, and FDA decisions. Psychedelic trials illustrate this, where robust well-being gains sometimes accompany modest symptom effects. We argue well-being should be elevated to co-primary endpoint status, propose a Delphi-developed consensus well-being instrument with rigorous validation, and outline guardrails preventing approval of therapies that worsen the underlying condition.

PMID:
42581324
Bibliographic data and abstract were imported from PubMed on 12 Aug 2026.

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