brb.nci.nih.govBiometric Research Program (BRP)

Skip to Content Home | Sitemap | Contact BRP Home About BRP Staff Directory Biostatistics Branch Computational & Systems Biology Branch BRP Alumni Position Available Research Area Clinical Trials Drug Discovery and Pre-Clinical Development Molecular Cancer Diagnosis Biomedical Imaging Computational and Systems Biology Biostatistical Research Online Sample Size Calculation Predictive Biomarkers in Phase II/III Clinical Trials Optimal Two-Stage Designs for Phase II Clinical Trials Integrated Phase II/III Study Sample Size Planning for Developing Classifiers Design, Monitoring and Analysis of Bayesian Basket Discovery Trials Bayesian Phase II Single Arm Clinical Trials Software Download Accelerated Titration Design Software BRB-ArrayTools BRB-SeqTools D3Oncoprint OpenGeneMed Optimal Two-Stage Phase II Design Software pCR Trial-Level Surrogate Analysis Software Publications and Reports Reprints Workshop Presentations -- 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. [Learn more] NCI TP Workbench This website has been developed using advanced computational and visualization tools for empowering developmental therapeutics investigators worldwide and providing them access to the genome-wide characterization of the NCI-60 cell lines and the enormous time-course databases on genome-wide response to treatment with drugs. [Learn more] OpenGeneMed 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] BRB-ArrayTools BRB-SeqTools NCI TP Workbench BayesianBasketDesign pCR Surrogacy OpenGeneMed 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. Associate Director Dr. Lisa Meier McShane, the Associate Director, leads the Biometric Research Program, Division of Cancer Treatment and Diagnosis, U.S. National Cancer Institute, National Institutes of Health. She was formerly Chief of the Biostatistics Branch within the program and now has oversight and strategic planning responsibilities for both branches in the program, including additionally the Computational and Systems Biology Branch. She holds a doctoral degree in Statistics from Cornell University in Ithaca, NY and is an elected Fellow of the American Statistical Association. She is a recognized expert in development of tumor marker-based tests for prognosis, therapy selection, and disease monitoring. More… BRP Home Contact BRP Policies Accessibility Privacy Policy FOIA File Readers/Plug-ins Site Map U.S. Department of Health and Human Services National Institutes of Health National Cancer Institute USA.gov NIH… Turning Discovery Into Health ®...