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