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 Research
that discusses statistical aspects of biomarker adaptive design for randomized clinical trials. The review covers statistical issues, such as:
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.
-
NCTR Research Highlights Archives
-
.png)
No hay comentarios:
Publicar un comentario