The Biostatistics Core will interact and provide statistical support. We will support projects with design and statistical consultation at each step of a study's progress, and provide state-of-the-art statistical analyses of often complex data. Data collection, management, and storage are also key components of the success of the Biostatistics Core and the PPG as a whole. The Biostatistics Core statisticians have extensive experience with both clinical trials and laboratory outcomes and will provide design and analysis consultation in addition to fully collaborating whenever it is deemed useful. 2.1 Projected Operation Core members will assist in the design, collection, storage, quality control, visualization, analysis, quantitative modeling, and interpretation of data arising in the course of program activities. They will accomplish these goals by engaging in the following activities: ? Help formulating and developing an important scientific question into a feasible and appropriate study design that will allow the study to meet its stated objectives. Advise on any modifications in study designs that might become necessary as a Project progresses. ? Develop non-standard study designs when necessary to achieve specific study objectives. ? Ensure that there are clear and consistent definitions of study objectives, eligibility criteria, primary and secondary endpoints for analysis, and evaluation criteria. ? Establish and conduct quality control procedures. Implement plans for interim monitoring and analyses of study data when appropriate. ? Design, perform, and present statistical analyses. ? Develop new, non-standard analysis tools when necessary to achieve study-specific or Programmatic goals. Conduct relevant methodological research and evaluation of the new tools. ? Actively participate in PPG-wide and Project specific meetings. ? Collaborate in the preparation of manuscripts and abstracts based on study results. ? Organize educational sessions to inform investigators about methods and software and train fellows and data coordinators when necessary ? Mentor fellows and junior faculty with regard to quantitative research methods, both in clinical trials and laboratory experiments. Successful implementation of these steps requires a committed and structured interaction between Core and Project investigators, proceeding along the following lines: 1) all aims of all Projects have a Core member as a co-investigator;whenever appropriate he/she will also be co-author of manuscripts 2) investigators will meet with the Core member on a regular basis for updates on ongoing studies and to discuss and design new studies, 3) consultation regarding feasibility, experimental design, and database issues will be provided as an integral part of study development along with the clinical and biological discussions, 4) consultation and advice regarding data visualization and exploratory techniques will be provided on an ongoing basis and as an integral part of study development. The basis for these strategies is in the Core biostatisticians'extensive expertise in areas important to the Projects, and in the demonstrated commitment to using quantitative methodology in interdisciplinary settings to pursue translational research. The PPG will meet regularly (at least monthly) to discuss projects, progress, and to allow a forum for new results and ideas. The Biostatistics Core members will participate in these meetings to keep abreast of Project developments and to provide consultation to Project leaders with regards to study design, data collection, and sample size considerations. These multidisciplinary meetings will be a critical component of the PPG, aiding in interaction between projects and cores.
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