Trials of AI Interventions Must Be Preregistered

AbstractArtificial intelligence (AI) must meet the same bar for clinical evidence as other clinical interventions. Trials that start enrolling patients after January 1, 2025 and that use an AI intervention as part of an approach to answering a clinical question will need to be registered in a trial database that meets the World Health Organization (WHO) International Clinical Trials Registry Platform specification or contributes data to this WHO platform if the final work is to be considered for publication in NEJM AI.