Document Detail

Biomarkers, subgroup evaluation, and clinical trial design.
MedLine Citation:
PMID:  22463794     Owner:  NLM     Status:  In-Data-Review    
Advances in clinical and basic sciences are raising the potential to use genetic and clinical biomarkers to identify a subgroup of patients who would most likely benefit from treatment, and to evaluate the benefit of treatment in that subgroup. To make full use of this potential, special clinical trial designs and analyses are needed. For identifying and evaluating a subgroup based on a single continuous biomarker, the most informative approach is the biomarker-analysis design, which is a randomized trial whose analysis involves estimation of the treatment benefit within patient groups defined with respect to various cutpoints or intervals of the biomarker. For identifying and evaluating a subgroup considering a range of possible markers, the adaptive signature design is recommended. In the adaptive signature design, participants are randomly split into training and test samples, a rule for creating the subgroup is formulated in the training sample, and treatment benefit is estimated in the test sample. The adaptive signature design can be usefully extended via the sliding-window subgroup plot that was originally developed for the biomarker-analysis design.
Stuart G Baker; Barnett S Kramer; Daniel J Sargent; Marco Bonetti
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Discovery medicine     Volume:  13     ISSN:  1944-7930     ISO Abbreviation:  Discov Med     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-04-02     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101250006     Medline TA:  Discov Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  187-92     Citation Subset:  IM    
Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland 20892, USA.
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