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Current Highlight from February 5, 2016

Investigators Propose New Precision Medicine Algorithms

The FDA in collaboration with the National Taiwan University has developed new algorithms to improve classification of patients into treatment sensitive and treatment non-sensitive groups; and an accompanying method to evaluate the effectiveness of treatment in the subgroups.  A supplemental procedure also enables the classification of patients in a continuum of responsiveness to therapy.  The success of adaptive clinical design is a cornerstone of improving precision medicine both for accurately identifying treatment-responsive subgroups and predicting the probability of achieving drug effectiveness.  This new proposal for using the Diagonal Linear Discriminant Analysis procedure is compared against the more commonly known   Adaptive Signature Design, using publically available cancer data sets and simulation.  The proposed procedure provides an effective approach for identifying a responder subgroup so that an effective treatment can be efficiently approved and administered only to those patients who are likely to benefit from the treatment. 

For additional information, please contact James J Chen, Ph.D., Division of Bioinformatics and Biostatistics, FDA/NCTR  (doi: 10.1186/s12874-015-0098-7).

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Page Last Updated: 02/09/2016
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