Trials of AI Interventions Must Be Preregistered
Jeffrey M. Drazen, Charlotte Haug
Abstract
Artificial 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.
Topics & Concepts
Psychological interventionClinical trialIntervention (counseling)Medical educationPsychologyMedicinePsychiatryPathologyArtificial Intelligence in Healthcare and EducationRadiomics and Machine Learning in Medical ImagingMeta-analysis and systematic reviews