The integration of Artificial Intelligence (AI) technologies into clinical practice holds significant promise for revolutionizing healthcare. However, the realization of this potential requires rigorous evaluation and validation of AI applications to ensure their safety, efficacy, and clinical significance. Despite increasing awareness of the need for robust testing, the majority of AI-related Randomized Controlled Trials (RCTs) so far have exhibited notable limitations, impeding the generalizability and proper integration of their findings into clinical settings. To understand whether the field is progressing towards more robust testing, we conducted an analysis of the registration data of ongoing and planned RCTs of AI in medicine available in the Clinicaltrials.gov database. Our analysis highlights several key trends and challenges. Effectively addressing these challenges is essential for advancing the field of medical AI and ensuring its successful integration into clinical practice.

The authors have declared no competing interest.

This study did not receive any funding

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I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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All data produced in the present study are available upon request to the authors.