N-of-1 trials in cancer drug development

The current approaches for cancer drug development lag behind an accelerated need in the field for a fast and efficient method for evaluating drugs in the personalized medicine era. In that regard, N-of-1 studies emerge as a potential addition to the drug development arsenal, although there are seve...

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Hauptverfasser: Gouda, Mohamed A. (VerfasserIn) , Buschhorn, Lars (VerfasserIn) , Schneeweiss, Andreas (VerfasserIn) , Wahida, Adam (VerfasserIn) , Subbiah, Vivek (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: 1 June 2023
In: Cancer discovery
Year: 2023, Jahrgang: 13, Heft: 6, Pages: 1301-1309
ISSN:2159-8290
DOI:10.1158/2159-8290.CD-22-1377
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1158/2159-8290.CD-22-1377
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Verfasserangaben:Mohamed A. Gouda, Lars Buschhorn, Andreas Schneeweiss, Adam Wahida, and Vivek Subbiah

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520 |a The current approaches for cancer drug development lag behind an accelerated need in the field for a fast and efficient method for evaluating drugs in the personalized medicine era. In that regard, N-of-1 studies emerge as a potential addition to the drug development arsenal, although there are several considerations before its broad application becomes feasible. In essence, N-of-1 trials are a departure from the traditional “drug-centric” model to a “patient-centric” model. Herein, we review the concept of N-of-1 trials and provide real-world examples of their use in the developmental therapeutics field. N-of-1 trials offer an exceptional opportunity for fast-tracking of cancer drug development in the precision oncology era. 
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