Brain and Spinal Injury Center, Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, USA.
San Francisco Veterans Affairs Healthcare System, San Francisco, CA, USA.
Neurotherapeutics. 2023 Oct;20(6):1433-1445. doi: 10.1007/s13311-023-01400-5. Epub 2023 Jul 31.
The use of animal models in pre-clinical research has significantly broadened our understanding of the pathologies that underlie traumatic brain injury (TBI)-induced damage and deficits. However, despite numerous pre-clinical studies reporting the identification of promising neurotherapeutics, translation of these therapies to clinical application has so far eluded the TBI research field. A concerted effort to address this lack of translatability is long overdue. Given the inherent heterogeneity of TBI and the replication crisis that continues to plague biomedical research, this is a complex task that will require a multifaceted approach centered around rigor and reproducibility. Here, we discuss the role of three primary focus areas for better aligning pre-clinical research with clinical TBI management. These focus areas are (1) reporting and standardization of protocols, (2) replication of prior knowledge including the confirmation of expected pharmacodynamics, and (3) the broad application of open science through inter-center collaboration and data sharing. We further discuss current efforts that are establishing the core framework needed for successfully addressing the translatability crisis of TBI.
在临床前研究中使用动物模型,极大地拓宽了我们对创伤性脑损伤(TBI)引起的损伤和缺陷的病理机制的理解。然而,尽管有许多临床前研究报告了有希望的神经治疗方法的确定,但这些疗法在向临床应用的转化方面一直未能实现。迫切需要做出一致的努力来解决这种转化不足的问题。鉴于 TBI 的固有异质性以及继续困扰着生物医学研究的复制危机,这是一项复杂的任务,需要围绕严谨性和可重复性展开多方面的方法。在这里,我们讨论了三个主要关注领域的作用,以更好地将临床前研究与 TBI 的临床管理相结合。这些重点领域是(1)报告和标准化方案,(2)复制以前的知识,包括确认预期的药效学,以及(3)通过中心间合作和数据共享广泛应用开放科学。我们进一步讨论了目前正在为成功解决 TBI 的可转化性危机建立核心框架所做的努力。