Original Article
Challenges of clinical translation in nanomedicine: A qualitative study

https://doi.org/10.1016/j.nano.2015.12.376Get rights and content

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.

From the Clinical Editor

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.

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.

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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.

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