Core B - Biostatistics Core

ABSTRACT: Biostatistics Core (Core B) The Biostatistics Core (Core B) will provide coordinated support for study design, data sharing, and data analysis across all projects and cores. This shared resource will provide support for planning and sample size determination, for quality control and integration of data, for public sharing of data through NIH-approved mechanisms, for appropriate and reproducible statistical analysis, and for the summarization and visualization of data in publications resulting from the P01. Specific Aim 1: To provide input on statistical design, sample size determination, and analytical methods for all projects and cores. Core B personnel will support the project and core leads to ensure that the scientific hypotheses are clear and testable, and that the clinical and experimental approaches are appropriate to address them. This will entail providing input on study designs, sample sizes, and statistical considerations for all projects. For projects that include clinical trials, this entails providing biostatistical support for the trial design, protocol development, and any interim and final analyses of the data collected. For projects that entail machine learning, this includes plans for separation of training, testing, and validation data sets, and rigorous evaluation of predictive accuracy. Specific Aim 2: To facilitate quality control, integration, and sharing of data across all projects and cores. Core B will contribute to the data cleaning and organization and ensure that the projects and cores follow appropriate procedures for data sharing as described in the NIH Policy for Data Management and Sharing. Specific Aim 3: To provide all statistical data analysis, including hypothesis testing, statistical modeling, and exploratory analysis, for all projects and cores. This aim will entail the generation of statistical reports for all projects using reproducible methods and supporting all project investigators in the publication of scientific results. The core will ensure that the analyses conducted are appropriate, and will apply existing frequentist and Bayesian methods, and develop or adapt innovative methods pertinent to the project goals. For clinical trials, Core B will ensure rigorous analysis following the analysis plan laid out in the clinical trial protocol. Dr. Christine B. Peterson will be responsible for coordinating all Core B activities, including collaboration with project and core leads, and supervision and training of a staff biostatistician and postdoctoral fellow. She will also coordinate activities with Dr. Ruitao Lin, who will be responsible for the clinical trial component of Project 3.