) The National Surgical Adjuvant Breast and Bowel Project (NSABP) is an NCI-funded clinical trials cooperative group for cancer treatment and prevention and control research with a 40-year history of conducting large-scale controlled trials. In 1992, the NSABP extended its research agenda to include cancer prevention trials. The NSABP has been a CCOP Research Base since the inception of the CCOP Program in 1983, and 54 CCOPs currently list the NSABP among their research bases. CCOP participation in NSABP treatment and prevention trials is substantial; approximately 38% of NSABP accrual is attributable to CCOP investigators. This application requests continued funding for the NSABP to continue as a CCOP Research Base for the period June 1, 2001 through May 31, 2006. During the proposed grant period, the NSABP will: 1) continue to design and implement multi-institutional cancer treatment and prevention and control clinical trials; 2) analyze, report, and publish the results of current NSABP studies; 3) implement recruitment mechanisms and procedures to achieve adequate accrual and foster the participation of women and minorities in NSABP clinical trials; 4) maintain data collection, data monitoring, and quality control procedures that are in compliance with federal guidelines; 5) monitor CCOP performance through ongoing quality assurance programs; and 6) continue the integration of CCOP investigators into the overall functioning of the NSABP. In completing these tasks, the specific responsibilities of the Biostatistical Center will include: (I) statistical and logistical design of protocols and ancillary studies; (ii) database design and implementation; (iii) patient/participant eligibility screening and registration; (iv) data management, security and quality assurance; (v) safety, compliance and endpoint monitoring; (vi) preparing reports for treatment and prevention data monitoring committees; (vii) expedited adverse event reporting to regulatory agencies; (viii) statistical analysis of study data; (ix) collaborating in publication of abstracts and manuscripts; (x) managing the on-site audit program; (xi) collaborating in institutional evaluation; and (xii) publishing an annual progress report for the membership.
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