(Applicant's narrative) This application requests funding which will enable us to continue to serve as the Biostatistical Center for the National Surgical Breast and Bowel Project (NSABP) CCOP. We intend to accomplish the following objectives: Collaborate with clinical colleagues at the Operations Center in all phases of the clinical trial process, including concept development, protocol design, implementation, data management, study monitoring, analysis of data, and publication of results. Ensure that the study design specified in each protocol is consistent with the protocol's stated objectives, that the specified accrual is sufficient to test the primary hypotheses, that protocol requirements, endpoints and procedures are clearly stated, and that the analysis of results is timely and appropriate. Participate in the design, implementation, management and analysis of ancillary studies nested within NSABP treatment and cancer control trials to address relevant biological and clinical research questions. Provide data management support as needed to centralized laboratories involved in ancillary studies. Assume responsibility for all aspects of data quality assurance, including (i) the on-site audit program; (ii) monthly institutional performance reports of accrual and data delinquency status; (iii) patient safety and treatment monitoring, including medical review; (iv) internal data quality review; and (v) internal and external continuing education. Carry out all aspects of data monitoring and interim reporting, encompassing (i) planned interim analyses of primary endpoints, as specified per protocol; (ii) routine reports of accrual, eligibility and toxicity; (iii) group regulatory compliance, including adverse events reporting; (iv) ongoing monitoring of second primary cancers, and (v) preparation of an annual Progress Report for the membership and study sponsors. Coauthor presentations, abstracts and manuscripts based on protocol results, or other group data as appropriate, ensuring that the conclusions of such publications are based on correct and clearly stated statistical methodology. Provide support for educational programs for CCOP staff. Provide data required by NSABP for the evaluation of CCOP performance and for the fulfillment of regulatory commitments.
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