Neuropsychological Research Organization s.l. (Neuropsynchro), Barcelona, Spain.
Hospital del Mar Research Institute; CIBER de Epidemiología y Salud Pública, Instituto de Salud Carlos III; Universitat Pompeu Fabra, Barcelona, Spain.
Eur Neuropsychopharmacol. 2024 Jun;83:32-42. doi: 10.1016/j.euroneuro.2024.02.009. Epub 2024 Apr 4.
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.
神经科学临床试验的失败率一直居高不下。在早期临床试验中选择适当的结局指标是最大限度地发现精神科和神经科新疗法的关键。该领域在设计结局策略方面缺乏良好的标准，因此成立了结局研究小组，以制定和推广结局选择方面的良好实践。本文描述了神经科学临床结局标准化过程的首批公布指南。该指南定义了一个尽可能早开始的最小步骤流程，涵盖了支持内容有效性、以患者为中心、有效性要求以及监管接受考虑的证据生成的关键活动。提供了专家成员的反馈意见，讨论了缩短流程的风险，并总结了支持推荐流程的示例。该方法现已提供给行业、学术界或临床医生的研究人员，旨在为临床结局选择实施基于共识的标准实践，有助于提高临床研究的效率。
