BIOSTATISTICS SHARED RESOURCE (BSSR): PROJECT SUMMARY The primary goal of the Biostatistics Shared Resource (BSSR) is to facilitate the peer -reviewed researchof Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) members. BSSR collaborates with members from all four research programs throughout all phases of cancer-related research projects. Major responsibilities are assumed for methodological, statistical, and computational issues, including study design, sampling, statistical aspects of clinical trial monitoring, interim reviews, and final analyses. BSSR supports the following four areas: (1) clinical research protocol development, including development of appropriate statistical designs, preparation of statistical sections, and review of the statistical content of all protocols submitted for Protocol Review Committee review at the WFBCCC; (2) clinical trial monitoring and analyses, including monitoring patient accrual, providing support for quality assurance efforts, and performing interim (when needed) and final analyses; (3) statistical design and data analysis in support of grant development and publications, to provide guidance and support in all stages of grant development and dissemination of research findings; this aspect of service involves meeting with WFBCCC investigators to discuss the design and analysis plans for potential grants, conducting regular planning sessions to brainstorm with WFBCCC investigators about potential grants, performing statistical analyses of data, and providing interpretations of results as parts of presentations, abstracts, and publications; and (4) leadership, education, and training, including participation in graduate-level courses, T32-supported training grants, mentoring teams for K awardees and other junior investigators, coordination of a Clinical Trials Boot Camp for early-stage investigators, and membership/leadership on committees responsible for scientific and administrative decisions for the WFBCCC. BSSR is directed by Ralph D’Agostino Jr., PhD, FASA. During the current funding period (11/01/2015-10/31/2020), BSSR assisted over 130 different investigators annually from over 22 different departments at Wake Forest who performed cancer- related research. BSSR also assisted with over 250 grant submissions during this funding period. Among these submissions, in the last year alone (11/01/2019-10/31/2020), BSSR members collaborated on over 40 different extramurally funded grants, with over $15 million in annual direct costs awarded. In addition, BSSR members co-authored over 220 peer-reviewed cancer-related papers with at least 14 publications with impact factor >10 during the funding period. BSSR also provides statistical support for a Program Project Grant (PPG) in glioblastoma which is based in the Neuro Oncology Program (P01CA207206). BSSR members are currently supporting ongoing work developing new PPG submissions in brain metastases and prostate cancer as well as a P50 Specialized Progra...