School of Behavioral and Brain Sciences, University of Texas at Dallas, Dallas, Texas 75080, USA.
Department of Defense, Defense Health Agency, Falls Church, Virginia 22042, USA.
J Acoust Soc Am. 2019 Nov;146(5):3646. doi: 10.1121/1.5133385.
Noise-induced hearing loss (NIHL) is a common injury for service members and civilians. Effective prevention of NIHL with drug agents would reduce the prevalence of NIHL. There are a host of challenges in translation of investigational new drug agents from animals into human clinical testing, however. Initial articles in this special issue describe common pre-clinical (animal) testing paradigms used to assess potential otoprotective drug agents and design-related factors that impact translation of promising agents into human clinical trials. Additional articles describe populations in which NIHL has a high incidence and factors that affect individual vulnerability. While otoprotective drugs will ultimately be developed for use by specific noise-exposed populations, there has been little effort to develop pre-clinical (animal) models that accurately model exposure hazards across diverse human populations. To facilitate advances in the translational framework for NIHL otoprotection in pre-clinical and clinical testing, the overarching goals of the current series are to (1) review the animal models that have been used, highlighting the relevance to the human populations of interest, (2) provide insight into the populations for whom pharmaceutical interventions might, or might not, be appropriate, and (3) highlight the factors that drive the significant individual variability observed in humans.
噪声性听力损失(NIHL)是军人和平民常见的损伤。用药物预防 NIHL 将降低 NIHL 的发病率。然而,将研究性新药从动物转化为人体临床试验存在许多挑战。本特刊中的最初几篇文章描述了用于评估潜在的耳保护药物和影响有前途药物向人体临床试验转化的设计相关因素的常见临床前(动物)测试范例。其他文章描述了 NIHL 发病率高的人群以及影响个体易感性的因素。虽然耳保护药物最终将针对特定的噪声暴露人群开发,但很少有努力开发能够准确模拟不同人群暴露危害的临床前(动物)模型。为了促进在临床前和临床试验中进行 NIHL 耳保护的转化框架取得进展,本系列的总体目标是:(1)回顾已使用的动物模型,突出其与相关人类群体的相关性;(2)深入了解可能或不可能适合药物干预的人群;(3)突出导致人类个体差异显著的因素。