Testing oncological treatments in the era of personalized medicine

David Teira, Testing oncological treatments in the era of personalized medicine. G. Boniolo y M. Nathan, 2016 (bookPart)

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Título Testing oncological treatments in the era of personalized medicine
Autor(es) David Teira
Abstract Should conventional randomized clinical trials provide the standard of safety and efficacy when testing targeted treatments for cancer? Should we make amendments to our current regulatory standard, stick to it, or dispense with it? I am going to maintain that, under certain circumstances, smaller phase II trials provide good enough grounds to grant regulatory approval for targeted therapies. My argument will hinge on the size of trial population, showing how this size is important not only for scientific considerations, but also for ethical and political reasons. The current system was designed to provide massive consumer protection at a point when our understanding of the biology of cancer was still relatively poor and statistical tests gave the only solid evidence about treatment effects. With targeted therapies, risks are hedged in a way that allows patients (if well informed) to make decisions for themselves, instead of deferring on pharmaceutical regulators.
Palabras clave small trials
phase II trials
targeted treatments
Editor(es) G. Boniolo
M. Nathan
Fecha 2016-01-01
Formato application/pdf
Identificador bibliuned:501090
Versión de la publicación acceptedVersion
Tipo de recurso bookPart
Tipo de acceso Abierto

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Creado: Sun, 03 Apr 2016, 08:54:07 CET