The Weill Cornell Medicine and The Ohio State University Mechanism-Based Targeting of Mantle Cell Lymphoma Program Project Grant Biostatistics Core consists of two highly experienced biostatisticians who will dedicate efforts to support all projects and cores that comprise this grant application. The core aims to provide long-term collaborative support to the three major projects and also to work closely with members of the other cores and provide them with needed biostatistical support. Specifically, the Biostatistics Core will collaborate with investigators on study design, conduct, data collection and management, and analysis plans for laboratory and animal studies (aim 1), clinical studies (aim 2), and profiling studies (aim 3), including experimental design, sample size and power calculations, assessment of feasibility, application of appropriate statistical analysis techniques, and summarization of findings. The biostatistical support on high-dimensional data analysis with each project will be provided through a close and synergistic relationship with the Genomics & Bioinformatics Core. In addition, core members will monitor the research progress, will provide a centralized repository for data generated from P01 projects and cores, will standardize data collection across the projects and core, will perform quality checks on data, and will develop novel statistical methods if emerging statistical issues from the P01 projects require so. The Biostatistics Core will play a key role in facilitating synergies across the projects and core through the sharing of data, results, and lessons learned. Through the already existing interaction with the project leaders, core members have co-authored several publications related to Mantle Cell Lymphoma. There is also an established collaborative partnership between members of the Biostatistics and Genomics & Bioinformatics Cores with respect to the analysis of high- dimensional genetic, genomic, epigenetic, and proteomic data. In conjunction with the Administrative Core, the Pathology Core, and the Genomics & Bioinformatics Core, we will ensure all the projects progress as planned, and the results are accurate and reliable. !
The Biostatistics Core will provide the full spectrum statistical services for all Projects and Cores that are part of this P01. These include statistical design and analysis for correlative studies, laboratory studies, and clinical research studies. In addition to performing all the analyses described in the core, we recognize that based on findings of on-going projects that there may be other analyses that need to be done and are prepared to perform these as well. Finally, if and when needed, we will develop new statistical methodologies in order to perform the necessary analyses required by projects and cores within the scope of the P01.