miércoles, 11 de junio de 2014

NCTR Publications > NCTR Research Highlights

NCTR Publications > NCTR Research Highlights

National Center for Toxicological Researh log with FDA on left side

Current Highlight from June 6, 2014

Biomarker Adaptive Designs in Clinical Trials
Scientists from FDA's NCTR and CDER, and Moffitt Cancer Center and Research Institute, have published a review article in Translational Cancer Researchdisclaimer icon that discusses statistical aspects of biomarker adaptive design for randomized clinical trials.  The review covers statistical issues, such as:
  • the interaction test to identify predictive biomarkers
  • subgroup analysis
  • multiple testing and false discovery rate
  • classification of imbalanced class size data
  • sample size and power
  • validation of the classification model
As the development of new molecularly-targeted cancer drugs that may only benefit a subgroup of patients becomes more common, biomarker-adaptive designs could identify the most suitable target subpopulations based on clinical observations or known biomarkers, and evaluate the effectiveness of the treatment on that subpopulation in a statistically valid manner. 
For additional information, contact James Chen, Ph.D., Director, Biostatistics Branch, Division of Bioinformatics and Biostatistics, FDA/NCTR. 

Contact FDA

National Center for Toxicological Research
Food and Drug Administration
3900 NCTR Road
Jefferson, AR 72079

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