CANCER BIOSTATISTICS SHARED RESOURCE: PROJECT SUMMARY The Cancer Biostatistics Shared Resource (CBSR) provides essential capabilities and infrastructure in support of Herbert Irving Comprehensive Cancer Center (HICCC) members by providing statistical expertise to basic and clinical researchers who are conceptualizing and developing research projects and clinical trials. The CBSR offers a wide range of services including (1) summarizing statistical considerations for grant applications and scientific publication such as power analyses, forms creation, measures specifications, and simple consultations on study design and biostatistics analyses; (2) identifying and defining outcome variables and covariates; (3) analyzing expected effect sizes; (4) designing stratification and randomization schemes; (5) designing human study-specific features such as stopping rules for toxicity; and (6) interim analysis procedures for efficacy, futility, and blinding. In these functions the CBSR assists HICCC members by ensuring data rigor and reproducibility; providing descriptive and summary statistics in the form of tables, charts, and graphs; conducting specified as well as ancillary and exploratory analyses; assisting with manuscript preparation; and reviewing completed studies for accurate reporting and proper interpretation of results. The CBSR has been completely restructured following the recruitment of Jianhua Hu, PhD, as CBSR Director in 2018 and now provides a comprehensive, accessible, cost-effective, and well-structured array of services to HICCC members. Because of unique expertise, costly computational infrastructure, and complex analytics requiring direct interaction and high accessibility, the CBSR services cannot be effectively accessed commercially or via external academic units. In addition to analytical services, the CBSR also provides training to HICCC members and serves as an educational resource for the HICCC. The CBSR has developed standardized operating procedures for data handling, management, analysis, and reporting to ensure completeness and appropriateness of analytic procedures, safeguarding the highest standards in rigor and reproducibility. The CBSR will continue to develop and incorporate new analytical and statistical methodology into the services offered in order to provide accessible, high-quality, and affordable statistical services to basic and clinical investigators in the HICCC, advancing the rigor, reproducibility, and value of the HICCC Research Programs. Since the recruitment of Dr. Hu as Director, the CBSR has been utilized by 36 HICCC members, supported multiple pilot grants, and serves an NCI funded P01 and two NCI SPOREs under review.
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