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Bringing Advanced Therapies for Parkinson's Disease to the Clinic : An Analysis of Ethical Issues

Hug, Kristina LU orcid (2021) In Journal of Parkinson's Disease 11(s2). p.147-153
Abstract

Advanced therapies for Parkinson's disease (PD) constitute a broad range of treatments, each presenting specific ethical challenges. Some of these therapies are established and in clinical use, like device-aided therapies, and others, based on advanced therapeutic medicinal products (ATMPs), are still in early stage of clinical trials. This paper focuses on some common ethical issues arising in these two categories of advanced therapies, especially challenges arising when advanced therapies are proposed to PD patients in the form of advanced care, under a clinical trial, or, in case of ATMPs, under the 'hospital exemption' rule. The ethical issues covered here relate mainly to ensuring informed consent in these different contexts, to... (More)

Advanced therapies for Parkinson's disease (PD) constitute a broad range of treatments, each presenting specific ethical challenges. Some of these therapies are established and in clinical use, like device-aided therapies, and others, based on advanced therapeutic medicinal products (ATMPs), are still in early stage of clinical trials. This paper focuses on some common ethical issues arising in these two categories of advanced therapies, especially challenges arising when advanced therapies are proposed to PD patients in the form of advanced care, under a clinical trial, or, in case of ATMPs, under the 'hospital exemption' rule. The ethical issues covered here relate mainly to ensuring informed consent in these different contexts, to the stakeholder role of patient's non-professional caretakers, such as family, and to patient safety in treatments under 'hospital exemption'. To illustrate the points discussed in connection with 'hospital exemption' rule, the example of the EU has been chosen. This paper does not claim completeness of ethical issues raised by bringing advanced therapies for PD to the clinic, but rather presents examples of ethical challenges in this context.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
advanced therapeutic medicinal products, advanced therapies, ethics, Parkinson's disease
in
Journal of Parkinson's Disease
volume
11
issue
s2
pages
147 - 153
publisher
IOS Press
external identifiers
  • scopus:85116067921
  • pmid:34092655
ISSN
1877-7171
DOI
10.3233/jpd-212639
language
English
LU publication?
yes
additional info
Publisher Copyright: © 2021 - The authors. Published by IOS Press.
id
4241a950-57a5-454a-83f5-3d2916e41355
date added to LUP
2021-10-22 15:25:01
date last changed
2024-06-15 19:00:15
@article{4241a950-57a5-454a-83f5-3d2916e41355,
  abstract     = {{<p>Advanced therapies for Parkinson's disease (PD) constitute a broad range of treatments, each presenting specific ethical challenges. Some of these therapies are established and in clinical use, like device-aided therapies, and others, based on advanced therapeutic medicinal products (ATMPs), are still in early stage of clinical trials. This paper focuses on some common ethical issues arising in these two categories of advanced therapies, especially challenges arising when advanced therapies are proposed to PD patients in the form of advanced care, under a clinical trial, or, in case of ATMPs, under the 'hospital exemption' rule. The ethical issues covered here relate mainly to ensuring informed consent in these different contexts, to the stakeholder role of patient's non-professional caretakers, such as family, and to patient safety in treatments under 'hospital exemption'. To illustrate the points discussed in connection with 'hospital exemption' rule, the example of the EU has been chosen. This paper does not claim completeness of ethical issues raised by bringing advanced therapies for PD to the clinic, but rather presents examples of ethical challenges in this context.</p>}},
  author       = {{Hug, Kristina}},
  issn         = {{1877-7171}},
  keywords     = {{advanced therapeutic medicinal products; advanced therapies; ethics; Parkinson's disease}},
  language     = {{eng}},
  number       = {{s2}},
  pages        = {{147--153}},
  publisher    = {{IOS Press}},
  series       = {{Journal of Parkinson's Disease}},
  title        = {{Bringing Advanced Therapies for Parkinson's Disease to the Clinic : An Analysis of Ethical Issues}},
  url          = {{http://dx.doi.org/10.3233/jpd-212639}},
  doi          = {{10.3233/jpd-212639}},
  volume       = {{11}},
  year         = {{2021}},
}