title: Challenges of clinical translation in nanomedicine: A qualitative study.
abstract: 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.
  
  
  BACKGROUND
  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.
authors.affiliation: Institute for Biomedical Ethics, University of Basel, Basel, Switzerland. Electronic address: priya.satalkar@unibas.ch.
authors.forename: Priya
authors.initials: P
authors.lastname: Satalkar
authors.affiliation: Institute for Biomedical Ethics, University of Basel, Basel, Switzerland. Electronic address: b.elger@unibas.ch.
authors.forename: Bernice Simon
authors.initials: BS
authors.lastname: Elger
authors.affiliation: Medical Intensive Care Unit, University Hospital Basel, Basel, Switzerland; CLINAM Foundation, Basel, Switzerland. Electronic address: patrick.hunziker@usb.ch.
authors.forename: Patrick
authors.initials: P
authors.lastname: Hunziker
authors.affiliation: Institute for Biomedical Ethics, University of Basel, Basel, Switzerland. Electronic address: david.shaw@unibas.ch.
authors.forename: David
authors.initials: D
authors.lastname: Shaw
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D050997:Nanomedicine / Q000639:trends*; D036103:Nanotechnology / Q000639:trends*; D057170:Translational Research, Biomedical / Q000639:trends*
keywords: Challenges; First in human (FIH) trials; Nanomedicine; Qualitative research; Translational research