• Emily Rao, Christine Grady, and David Wendler.
• Department of Psychiatry, Keck School of Medicine, USC, Los Angeles, CA.
• Crit. Care Med. 2024 Nov 11.

ObjectivesInnovative therapy is common in many areas of medicine. Yet, it is unknown whether medical centers have policies to ensure innovative therapy is conducted appropriately.DesignWe contacted three informants at leading U.S. medical centers to determine whether the center has a policy for innovative therapy and, if so, what requirements the policies include and whether the policies lack any important elements.SettingExisting policies and published recommendations.PatientsNone.InterventionsNone.Measurements And Main ResultsOur search found that 46 of 58 responding centers (79%) do not have a policy for innovative therapy. Of the ten policies available for review, half lack requirements to report patient outcomes, and half do not explicitly coordinate innovative therapy with research.ConclusionsA majority of leading U.S. medical centers do not have a policy for innovative therapy. In addition, existing policies lack important elements, especially with respect to reporting patient outcomes and coordinating innovative therapy with research. Based on the existing policies and recommendations in the literature, we thus identify eight key elements that should be included in policies for innovative therapy. Future research should assess whether these elements can be feasibly implemented and whether, in practice, they offer patients appropriate protection.Copyright © 2024 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.

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