Original ArticleChallenges of clinical translation in nanomedicine: A qualitative study
Graphical Abstract
Translational research is critical to improve health care but it is time and resource intensive. We present the challenges experienced by stakeholders involved in translational nanomedicine in Europe and North America. Financial, regulatory and ethical challenges experienced by the stakeholders are not unique to nanomedicine and will be encountered in any cutting edge biotechnology. Hence we argue for systemic solutions rather than those specific to nanotechnology such as effective collaboration and communication across different stakeholders, streamlined drug regulatory pathways, comprehensive risk assessment and ethical evaluation, meaningful patient engagement and political commitment.
Section snippets
Methods
Qualitative research methods are employed to investigate topics where previous empirical research has been scarce.24 We used semi-structured, in-depth interviews for this exploratory research project. We drew up a list of open ended questions to facilitate conversations with expert stakeholders involved in translational nanomedicine. This enabled respondents to freely narrate their experience and bring up topics, themes, and challenges that they deemed relevant. Three pilot interviews (with
Results
Our respondents were located in Switzerland, Germany, The Netherlands, Denmark, Norway, Austria, Hungary, Spain, Portugal, the United Kingdom, Israel, the United States and Canada. Their professional roles/affiliations and geographic distributions are shown in Figure 1 and Figure 2. Respondents were trained in medicine, molecular biology, biochemistry, material science, physics, toxicology, organic chemistry, pharmaceutical science, law, and ethics and had at least seven years of work
Discussion
Slow and scarce translational research is a global concern due to its adverse impact on the availability of affordable and effective treatment options. The financial, ethical and regulatory challenges presented in this paper have been discussed extensively in the literature on translation of other cutting edge biotechnologies such as gene transfer,5 cell therapy,28, 29, 30, 31 and regenerative medicine,32, 33 but our study is the first to actually investigate the experience of those involved in
Acknowledgements
We acknowledge Dr Daniela Vavrecka-Sidler for her assistance in preparing figures and images of graphical abstract in eps format for this manuscript.
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Funding statement: This study was funded by Swiss National Science Foundation (grant no. PDFMP3_137194/1) and Universität Basel Forschungsfonds.
Conflict of interest: None.