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

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dc.contributor.authorPepper, M. S.en_ZA
dc.contributor.authorPope, A.en_ZA
dc.contributor.authorKling, S.en_ZA
dc.contributor.authorAlessandrini, M.en_ZA
dc.contributor.authorVan Staden, W.en_ZA
dc.contributor.authorGreen, R. J.en_ZA
dc.date.accessioned2019-11-07T06:25:10Z
dc.date.available2019-11-07T06:25:10Z
dc.date.issued2018
dc.descriptionCITATION: Pepper, M. S. et al. 2018. Ethical considerations in the application of cell and gene therapies in children. South African Medical Journal, 108(12):1027-1029, doi:10.7196/SAMJ.2018.v108i12.13585.
dc.descriptionThe original publication is available at http://www.samj.org.za
dc.description.abstractENGLISH 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.urihttp://www.samj.org.za/index.php/samj/article/view/12496
dc.description.versionPublisher's version
dc.format.extent3 pagesen_ZA
dc.identifier.citationPepper, M. S. et al. 2018. Ethical considerations in the application of cell and gene therapies in children. South African Medical Journal, 108(12):1027-1029, doi:10.7196/SAMJ.2018.v108i12.13585.
dc.identifier.issn2078-5135 (online)
dc.identifier.issn0256-9574 (print)
dc.identifier.otherdoi:10.7196/SAMJ.2018.v108i12.13585
dc.identifier.urihttp://hdl.handle.net/10019.1/106802
dc.language.isoen_ZAen_ZA
dc.publisherHealth & Medical Publishing Groupen_ZA
dc.rights.holderAuthors retain copyrighten_ZA
dc.subjectImmunotherapyen_ZA
dc.subjectGene therapyen_ZA
dc.subjectMinorsen_ZA
dc.subjectClinical trialsen_ZA
dc.subjectMedical ethicsen_ZA
dc.subjectCanceren_ZA
dc.titleEthical considerations in the application of cell and gene therapies in childrenen_ZA
dc.typeArticleen_ZA
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