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Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist

In an era of escalating drug discovery costs, shifting priorities within the pharmaceutical industry, and longstanding challenges in central nervous system drug delivery, surgical trials offer an avenue to identify promising agents with demonstrable tumor penetration and molecular effects. The rise...

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Detalles Bibliográficos
Autor principal: Sanai, Nader
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6855937/
https://www.ncbi.nlm.nih.gov/pubmed/31245813
http://dx.doi.org/10.1093/neuros/nyz218
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author Sanai, Nader
author_facet Sanai, Nader
author_sort Sanai, Nader
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description In an era of escalating drug discovery costs, shifting priorities within the pharmaceutical industry, and longstanding challenges in central nervous system drug delivery, surgical trials offer an avenue to identify promising agents with demonstrable tumor penetration and molecular effects. The rise of pharmacodynamic- and pharmacokinetic-driven clinical trials, including phase 0 study designs, creates an opportunity for the neurosurgical oncologist to engage drug development for brain tumor patients directly. Here, we review the phase 0 clinical trial mechanism as well as its current and future applications within neurosurgical oncology.
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spelling pubmed-68559372019-11-20 Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist Sanai, Nader Neurosurgery Review In an era of escalating drug discovery costs, shifting priorities within the pharmaceutical industry, and longstanding challenges in central nervous system drug delivery, surgical trials offer an avenue to identify promising agents with demonstrable tumor penetration and molecular effects. The rise of pharmacodynamic- and pharmacokinetic-driven clinical trials, including phase 0 study designs, creates an opportunity for the neurosurgical oncologist to engage drug development for brain tumor patients directly. Here, we review the phase 0 clinical trial mechanism as well as its current and future applications within neurosurgical oncology. Oxford University Press 2019-12 2019-06-27 /pmc/articles/PMC6855937/ /pubmed/31245813 http://dx.doi.org/10.1093/neuros/nyz218 Text en © Congress of Neurological Surgeons 2019. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Review
Sanai, Nader
Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist
title Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist
title_full Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist
title_fullStr Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist
title_full_unstemmed Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist
title_short Phase 0 Clinical Trial Strategies for the Neurosurgical Oncologist
title_sort phase 0 clinical trial strategies for the neurosurgical oncologist
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6855937/
https://www.ncbi.nlm.nih.gov/pubmed/31245813
http://dx.doi.org/10.1093/neuros/nyz218
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