Methods for Neuroscience Drug Development: Guidance on Standardization of the Process for Defining Clinical Outcome Strategies in Clinical Trials

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, there...

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Bibliographic Details
Published in:European neuropsychopharmacology 2024-06, Vol.83, p.32-42
Main Authors: Zaragoza Domingo, Silvia, Alonso, Jordi, Ferrer, Montse, Acosta, Maria T., Alphs, Larry, Annas, Peter, Balabanov, Pavel, Berger, Anna-Karin, Bishop, Kim I., Butlen-Ducuing, Florence, Dorffner, Georg, Edgar, Chris, de Gracia Blanco, Manuel, Harel, Brian, Harrison, John, Horan, William P., Jaeger, Judith, Kottner, Jan, Pinkham, Amy, Tinoco, Daniella, Vance, Monika, Yavorsky, Christian
Format: Article
Language:English
Subjects:
Clinical trials
Clinical Trials as Topic - methods
Clinical Trials as Topic - standards
Drug development
Drug Development - methods
Drug Development - standards
Early trials
Endpoints
Humans
Neurosciences - methods
Neurosciences - standards
Outcome
Outcome Assessment, Health Care - methods
Outcome Assessment, Health Care - standards
Research Design - standards
Treatment Outcome
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Summary: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.
ISSN:0924-977X
1873-7862
DOI:10.1016/j.euroneuro.2024.02.009