Ethical considerations in the application of cell and gene therapies in children

Show simple item record Pepper, Michael Sean Pope, A. Kling, S. Alessandrini, M. Van Staden, W. Green, Robin J. 2019-07-31T10:54:51Z 2019-07-31T10:54:51Z 2018-12
dc.description.abstract Rapidly evolving fields such as cell and gene therapies that involve state-of-the-art technology hold out possibilities that may be ahead of what ethics, guidelines and the law have considered. This results in a regulatory lag. Furthermore, ethical and legal considerations are often debated in real time as issues pertaining to these technologies that were previously not considered begin to come to the fore. Finding the appropriate balance between facilitating potential therapeutic gains and ensuring the safety interests of recipients of the new treatments requires close attention, especially for minors. This vulnerable population frequently has off-label treatment prescribed on the basis of extrapolation of clinical trial data derived from adults, which is ethically and scientifically questionable. In this article we discuss how best to maintain ethical integrity while introducing innovative cell and gene therapies to minors. We advocate that clinical trials of promising innovative therapies should be designed so that testing in adults is followed as soon as possible by testing in minors, given the impressive gains that have recently been reported. en_ZA
dc.description.department Immunology en_ZA
dc.description.department Paediatrics and Child Health en_ZA
dc.description.librarian am2019 en_ZA
dc.description.sponsorship Work in MSP’s group is funded by the South African Medical Research Council (University Flagship and Extramural Unit awards). en_ZA
dc.description.uri en_ZA
dc.identifier.citation Pepper, M.S., Pope, A., Kling, S. et al. 2018, 'Ethical considerations in the application of cell and gene therapies in children', South African Medical Journal, vol. 108, no. 12, pp. 1027-1029. en_ZA
dc.identifier.issn 0256-9574 (print)
dc.identifier.issn 2078-5135 (online)
dc.identifier.other 10.7196/SAMJ.2018.v108i12.13585
dc.language.iso en en_ZA
dc.publisher Health and Medical Publishing Group en_ZA
dc.rights © 2019, South African Medical Association. All rights reserved. This article is licensed under a Creative Commons Attribution-NonCommercial Works License (CC BY-NC 3.0). en_ZA
dc.subject State-of-the-art technology en_ZA
dc.subject Ethics en_ZA
dc.subject Testing en_ZA
dc.subject Cell therapy en_ZA
dc.subject Gene therapy en_ZA
dc.subject Children en_ZA
dc.title Ethical considerations in the application of cell and gene therapies in children en_ZA
dc.type Article en_ZA

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