Clinical Onology Program Biostatistical Center

描述：（申请人？美国国家外科辅助乳房 和肠道项目（NSABP）是一个NCI资助的临床试验合作小组 癌症治疗和预防控制研究， 进行大规模对照试验的历史。1992年，NSABP 将其研究议程扩大到包括癌症预防试验。NSABP 自1983年CCOP计划成立以来，一直是CCOP研究基地， 54个CCOP目前将NSABP列为其研究基地。CCOP 大量参与NSABP治疗和预防试验; 大约38%的NSABP应计费用来自CCOP研究者。 该申请要求继续为NSABP提供资金，以继续作为一个 2001年6月1日至2006年5月31日期间的CCOP研究基地。期间 在拟议的赠款期内，NSABP将： 1)继续设计和实施多机构癌症治疗， 预防和控制临床试验; 2)分析、报告和发表当前NSABP研究的结果; 3)实施征聘机制和程序，实现适当的应计制 促进妇女和少数民族参与NSABP临床试验; 4)维护数据收集、数据监测和质量控制程序 符合联邦指导方针; 5)通过持续的质量保证方案监测CCOP的业绩; 6)继续将CCOP调查员纳入总体运作 关于NSABP 在完成这些任务时，生物统计学 中心将包括：（一）方案的统计和后勤设计， 辅助研究; ㈡数据库的设计和实施; ㈢ 患者/参与者资格筛选和登记;（iv）数据 管理、安全和质量保证; ㈤安全、合规和 终点监测; ㈥编写治疗和预防数据报告 监测委员会;（vii）加速向监管机构报告不良事件 （八）研究数据的统计分析;（九）合作 出版摘要和手稿;（x）管理现场审计 计划;（Xi）在机构评估方面进行合作;以及（xii）出版 向会员国提交年度进展报告。

DESCRIPTION: (Applicant?s Description) 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.