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Trials
Published in: Trials 2/2015

Open Access 01-12-2015 | Poster presentation

A flexible method for determining a biomarker positive population based on an efficacy target within a confirmatory study

Author: Chris Harbron

Published in: Trials | Special Issue 2/2015

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Excerpt

Precision medicine utilising biomarkers to identify those patients likely to obtain a benefit from receiving a particular treatment has the potential to deliver benefit across multiple stakeholders. These are dependent upon having a well-defined biomarker positive population, which for continuous biomarkers such as gene or protein expression includes defining a threshold or cut-off based upon observed clinical data. To obtain the desired precision in estimating such a cut-off frequently requires larger sample sizes than typically used in early phase studies. …
Metadata
Title
A flexible method for determining a biomarker positive population based on an efficacy target within a confirmatory study
Author
Chris Harbron
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue Special Issue 2/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-16-S2-P133

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