About the Biometric Research Program (BRP)

Biostatistical Research

BRP staff conduct independent and collaborative biostatistical research. This includes developing new biostatistical methodology, as well as evaluating currently used methods. The methods investigated by BRP staff include methods useful for the design, monitoring, and analysis of clinical trials; the design and analysis of biomarker studies; sampling methods and methods for the analysis of observational data; design and analysis of imaging studies; analysis of laboratory assay data; and analysis of genomic data. Current major research interests of the staff include:

• Clinical trials methodology including design, monitoring and analysis issue
• Bayesian methods in clinical trial design and analysis
• Multiple comparisons, including application to high-dimensional genomic data
• Clustering and prediction methods appropriate for high-dimensional genomic data
• Survival analysis, with special emphasis on randomized clinical trials
• Analysis of genetic data including familial association analysis
• Longitudinal data analysis
• Diagnostic and measurement error
• Design and analysis of biomarker assay evaluation studies
• Laboratory quality control
• Missing data
• Smoothing methods
• Nonparametric statistical methods
• Analysis methods of complex health surveys
• Spatial statistics
• ROC analysis and regression

Computational and Systems Biology

The Computational and Systems Biology Group develops statistical, mathematical, and computational methodology for the analysis of genomic, functional genomic, and other biological data. These functions allow them to identify cancer associated genes, elucidate their functions, determine the steps of tumor development, identify molecular targets, and develop genome based approaches to the prevention, detection, diagnosis, and treatment of cancer. The staff also train post-doctoral research fellows in statistical genomics, computational and systems biology, and bioinformatics. The group collaborates with intramural investigators in its research.

Clinical Trials

BRP staff ensure that all national therapeutic clinical trials sponsored by the National Cancer Institute use appropriate, reliable, and efficient statistical designs. The staff represents the National Cancer Institute in the interim statistical monitoring of these trials and provides advice to investigators within and outside the NCI on the design and analysis of medical studies.

BRP staff provide statistical collaboration in the clinical trials of the intramural Center for Cancer Research in the areas of neuro-oncology, urologic oncology, radiation oncology, and cancer prevention.

BRP staff conduct independent and collaborative research on the effects of new cancer treatments, and on improved statistical methodology for the evaluation of new treatments. The section also develops mathematical models for the design of treatment regimens for evaluation in clinical trials.

Drug Discovery and Pre-Clinical Development

BRP staff provide statistical leadership for the pre-clinical drug discovery and development activities of the Division of Cancer Treatment and Diagnosis. Staff collaborates in the design and implementation of analytic tools to predict clinical activity against a molecular target based on in-vivo models and in-vitro tumor cell line screens. Staff collaborate in the design and analysis of early clinical trials of new anti-cancer therapies. The particular focus is on the measurement of biologic effects associated with molecular targets. BRP staff also conduct research to develop more effective designs for pre-clinical studies and early clinical trials and provide advice to professional staff both within and outside of the NCI on the design and analysis of such studies.

Biomedical Imaging

BRP staff provide statistical expertise to the Biomedical Imaging Program regarding the design and analysis of trials relating to molecular, diagnostic, and therapeutic imaging. Such trials include technology evaluation and reader variability studies, large screening trials, early-phase studies of novel imaging-contrast agents, and image-guided therapy trials. Staff represent the NCI in the interim monitoring of these trials, as necessary. Additionally, staff collaborate in the design of databases for the development and evaluation of computer-assisted diagnostic (CAD) methods, which is a critical step in obtaining acceptance of such tools in the medical community. BRP staff also conduct research on statistical methods relevant to the imaging community. Current research topics include Receiver-Operator Characteristic (ROC) Curve regression and methods for estimating diagnostic accuracy without a gold standard for establishing true disease status.

Molecular Cancer Diagnosis

BRP staff provide statistical expertise to the Cancer Diagnosis Program (CDP) on matters relating to design and analysis of translational tumor marker studies, diagnostic marker assay evaluation, validation of new technologies for cancer diagnostics, and quality assurance issues for tumor banks. These efforts extend beyond NCI to participation in international collaborations to improve the quality of design, analysis, and reporting of tumor marker studies. BRP staff actively pursue collaborative research in molecular diagnostics, including studies involving gene expression profiling of tumors by microarrays. Their goal is developing improved molecular diagnostic classifications of tumors to better tailor cancer therapy to individual patients. In addition, staff maintain a vigorous research program for the development of improved statistical methodology for the analysis of tumor marker studies and high-dimensional genomic data.