BRB-ArrayTools is an integrated package for the visualization and statistical analysis of Microarray gene expression, copy number, methylation and RNA-Seq data. Since its release in 2001, BRB-ArrayTools has over 20,000 registered users in 65 countries and has been cited in over 3500 publications. [Learn more]
BRB-SeqTools is a new tool for NGS data analysis. It will support the importing, pre-processing, variant calling, and somatic mutation annotation of both RNA-Seq and DNA-Seq data, in either .FASTQ or .bam file format.
OpenGeneMed is an open and customizable version of the GeneMed system, a web-based informatics system developed for the Molecular Profiling based Assignment of Cancer Therapy (NCI-MPACT) clinical trial coordinated by the NIH. [Learn more]
Assessing pathological complete response as a trial-level surrogate endpoint for early-stage breast cancer
Our research indicates there is no evidence that pCR is a trial-level surrogate for EFS or OS, nor is there evidence that pCR could be used reliably to screen out non-promising agents from further drug development. [Learn more]
Design, Monitoring and Analysis of Bayesian Basket Discovery Trials
Basket trials are discovery trials rather than hypothesis testing trials where the objective is to discover rather then test hypothesis on which histological type or genomic alterations sensitize the tumor to the drug. This web-based application implements a new method based on Bayesian principles for the design, monitoring and analysis of Basket trials. [Learn more]
Welcome to the Biometric Research Program
The Biometric Research Program consists of a Biostatistics Branch and a Computational & Systems Biology Branch. The Biostatistics Branch provides statistical leadership and oversight for the national program of therapeutic and diagnostic clinical trials of the National Cancer Institute as well as translational research in developmental therapeutics, diagnostics and cancer imaging. The Biostatistics Branch also conducts research in methods for the design, monitoring and analysis of clinical trials and related studies. It consists of doctoral level statisticians.
The Computational & Systems Biology Branch collaborates in the pre-clinical programs of the DCTD to utilize genomic and proteomic technology to identify molecular targets, resistance mechanisms and effective new drugs, drug combinations and biomarkers for guiding treatment. Members of the Computational & Systems Biology Branch conduct research on mechanisms of carcinogenesis and systems pharmacology. The branch develops bioinformatic systems to support genomic variant based clinical trials and to enhance the ability of biologists and pharmacologists to analyze and interpret genome-wide data. The branch also collaborates in the analysis of genomic data from the clinical trials program of the NCI. The Computational & Systems Biology Branch consists of doctoral level staff with diverse backgrounds such as computational biology, bioinformatics, computer science, biology, pharmacology, medicine and biomedical engineering.
The philosophy of the Biometric Research Program is to have the staff combine two functions: (i) collaboration and consultation with the staff of the DCTD and intramural investigators of the NCI; and (ii) conduct self-initiated research on topics important to cancer research. Combining these functions has enabled the program to recruit and retain an expert staff and to provide the highest quality collaborations to DCTD and NCI scientists. It has also enabled the program to conduct research that has impacted the field and is motivated by key problems of current cancer research. The program does not have a grant, cooperative agreement or contract portfolio and does not sponsor extramural research.
Richard Simon, D.Sc., leads the Biometric Research Program and is chief of the Computational & Systems Biology Branch. He holds a doctoral degree in Applied Mathematics & Computer Science from Washington University in St. Louis Mo. He has developed many of the statistical methods used in cancer clinical trials including dynamically stratified randomization, optimal 2 stage phase 2 clinical trial designs, accelerated titration phase 1 designs, stochastic curtailment for futility monitoring, tests of qualitative treatment by covariate interactions, predictive biomarker based enrichment designs, adaptive biomarker driven clinical trial designs and Bayesian methods for subset analysis, factorial clinical trials, and active control clinical trials. Dr. Simon is a leader in the development and use of predictive biomarkers in therapeutic research. More…
Dr. Richard Simon will be the 2017 recipient of the Marvin Zelen Leadership Award in Statistical Science. This award recognizes an individual who by virtue of his/her outstanding leadership has greatly impacted the theory and practice of statistical science. Dr. Simon will deliver a public lecture on statistical science at T. H. Chan School of Public Health at Harvard University.
Dr. Laura Yee joined our program on Dec. 1, 2016.
Translational Computational & Systems Biologist position is available (Nov. 30, 2016). [click for details]
BRB-SeqTools v1.0 is released (Oct. 19, 2016). [click for details]