Early phase trials of novel hearing therapeutics: Avenues and opportunities.

Hear Res

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.

Published: September 2019

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.

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http://dx.doi.org/10.1016/j.heares.2019.07.003DOI Listing

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