新型听力治疗方法的早期试验：途径与机遇。
Early phase trials of novel hearing therapeutics: Avenues and opportunities.
作者信息
Schilder Anne G M, Su Matthew P, Mandavia Rishi, Anderson Caroline R, Landry Evie, Ferdous Tanjinah, Blackshaw Helen
机构信息
evidENT, Ear Institute, University College London, Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road, London, WC1X 8DA, United Kingdom; National Institute of Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre, Maple House, Suite A, 1st floor, 149 Tottenham Court Road, London, W1T 7DN, United Kingdom.
evidENT, Ear Institute, University College London, Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road, London, WC1X 8DA, United Kingdom; National Institute of Health Research (NIHR) University College London Hospitals (UCLH) Biomedical Research Centre, Maple House, Suite A, 1st floor, 149 Tottenham Court Road, London, W1T 7DN, United Kingdom.
出版信息
Hear Res. 2019 Sep 1;380:175-186. doi: 10.1016/j.heares.2019.07.003. Epub 2019 Jul 7.
Novel hearing therapeutics are rapidly progressing along the innovation pathway and into the clinical trial domain. Because these trials are new to the hearing community, they come with challenges in terms of trial design, regulation and delivery. In this paper, we address the key scientific and operational issues and outline the opportunities for interdisciplinary and international collaboration these trials offer. Vital to the future successful implementation of these therapeutics is to evaluate their potential for adoption into healthcare systems, including consideration of their health economic value. This requires early engagement with all stakeholder groups along the hearing innovation pathway.
新型听力治疗方法正沿着创新路径迅速发展并进入临床试验阶段。由于这些试验对听力领域来说是新事物，在试验设计、监管和实施方面面临挑战。在本文中，我们阐述了关键的科学和操作问题，并概述了这些试验所提供的跨学科和国际合作机会。这些治疗方法未来成功实施的关键在于评估其被纳入医疗保健系统的潜力，包括考虑其健康经济价值。这需要在听力创新路径上尽早与所有利益相关者群体进行接触。
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