Institute for Biomedical Ethics, University of Basel, Basel, Switzerland.
Medical Intensive Care Unit, University Hospital Basel, Basel, Switzerland; CLINAM Foundation, Basel, Switzerland.
Nanomedicine. 2016 May;12(4):893-900. doi: 10.1016/j.nano.2015.12.376. Epub 2016 Jan 6.
Clinical translation of breakthroughs in nanotechnology and nanomedicine is expected to significantly improve diagnostic tools and therapeutic modalities for various diseases. This will not only improve human health and well-being, but is also likely to reduce health care costs in the long run. However, clinical translation is a long, arduous, resource intensive process that requires priority setting, resource mobilization, successful national and international collaboration, and effective coordination between key stakeholders. The aim of this paper is to describe various challenges faced by the stakeholders involved in translational nanomedicine while planning and conducting first in human clinical trials. We draw on insights obtained from 46 in-depth qualitative interviews with key stakeholders from Europe and North America.
Translational research is a crucial step in bringing basic research into clinical reality. This is particularly important in a new field like nanomedicine. Clinical translation is a long and resource intensive process with difficulties along the way. In this article, the authors looked at the challenges faced by various parties in order to help identify ways to overcome these challenges.
预计纳米技术和纳米医学方面的突破的临床转化将极大地改善各种疾病的诊断工具和治疗方式。这不仅将提高人类的健康和福祉,而且从长远来看还可能降低医疗保健成本。然而,临床转化是一个漫长、艰巨、资源密集的过程,需要优先设定、资源调动、成功的国家和国际合作,以及关键利益相关者之间的有效协调。本文旨在描述参与转化纳米医学的利益相关者在规划和进行首例人体临床试验时所面临的各种挑战。我们借鉴了来自欧洲和北美的 46 名关键利益相关者的 46 次深入定性访谈中获得的见解。
转化研究是将基础研究转化为临床现实的关键步骤。在像纳米医学这样的新领域,这一点尤为重要。临床转化是一个漫长而资源密集的过程,其中存在诸多困难。在本文中,作者研究了各个方面面临的挑战,以便帮助确定克服这些挑战的方法。