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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Oxford University Press
2019
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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 |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-6855937 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Oxford University Press |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT sanainader phase0clinicaltrialstrategiesfortheneurosurgicaloncologist |