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Competing Interests: We declare no competing interests. The views expressed in this Comment are the personal views of the authors and should not be understood or quoted as being made on behalf of or reflecting the position of the regulatory agency or agencies or organisations with which the authors are employed or affiliated.

Neurosciences clinical trials continue to have notoriously high failure rates. Appropriate outcomes selection in early clinical trials is key to maximizing the likelihood of identifying new treatments in psychiatry and neurology. The field lacks good standards for designing outcome strategies, therefore The Outcomes Research Group was formed to develop and promote good practices in outcome selection. This article describes the first published guidance on the standardization of the process for clinical outcomes in neuroscience. A minimal step process is defined starting as early as possible, covering key activities for evidence generation in support of content validity, patient-centricity, validity requirements and considerations for regulatory acceptance. Feedback from expert members is provided, regarding the risks of shortening the process and examples supporting the recommended process are summarized. This methodology is now available to researchers in industry, academia or clinics aiming to implement consensus-based standard practices for clinical outcome selection, contributing to maximizing the efficiency of clinical research., Competing Interests: Disclosures Silvia Zaragoza Domingo Developed EPICOG-SCH Brief Cognitive Battery in Schizophrenia and provided services as consultant to pharma industry (Sanofi-Genzyme and Jazz Pharmaceuticals in different periods 2018-23). Jordi Alonso, Montserrat Ferrer, Peter Annas, Chris Edgar, Manuel de Gracia, Georg Dorffner, Brian Harel, Jan Kottner, Amy Pinkham and Daniella Tinoco, Maria T. Acosta, Larry Alphs, John Harrison and Judith Jaeger have no conflicts of interest. For Florence Butlen-Ducuing and Pavel Balabanov, the views expressed in this document are the personal views of the authors and may not be understood or quoted as being made for or reflecting the position of the European Medicines Agency (EMA) or any of its committees or working parties. Anna-Karin Berger is employed by Lundbeck A/S. Kim I. Bishop is the principal of Global Pharma Consultancy, LLC, a provider of CNS and cognitive psychopharmacology services with a particular focus on executive functioning. William P. Horan is an employee of and holds equity in Karuna Therapeutics. Christian Yavorksy is the Chief Scientific Officer at Valis Bioscience and reports no conflicts of interest. Monica Vance is the Chief Executive Officer of Santium Media Corporation and reports no conflicts of interest, (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)