A program project is being planned to examine various aspects of a novel immunotherapy for metastatic colon cancer. This proposal is for a Biostatistics Core to provide consultation and collaboration to the investigators. The goal of the Biostatistics Core is to provide advice on data management and statistical analysis services to enhance the quality of the work performed by the program researchers and to improve their productivity. As described in more detail below, a broad range of services and collaboration will be provided. Core members will be available to serve as true collaborators, having already been involved in the design of each of the three projects involving statistical analyses. Core members will continue to be involved in all projects through data collection, analyses, and manuscript writing:
The aims of the Biostatistics Core are to provide the following services: 1. Advise on study design issues as the studies evolve. 2. Advise on data management issues and preparation of files for statistical analyses. 3. Implement analytical methods defined in the project-specific proposals. 4. Conduct interim analyses, and assist with writing interim reports. 5. Conduct final analyses and assist with preparation for and writing of final reports, abstracts, manuscripts, and future research proposals. 6. Conduct exploratory analyses that may lead to generation of new hypothesis.
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