Clinical Onology Program Biostatistical Center

描述：(申请者？S描述)国家外科辅助乳房 肠道项目(NSABP)是由NCI资助的临床试验合作组织 为癌症治疗和预防控制研究提供了40年的经验 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计划开始以来，一直是CCOP研究基地， 目前有54家CCOP将NSABP列为其研究基地之一。CCOP 大量参与NSABP治疗和预防试验； 约38%的NSABP应计应归因于CCOP调查人员。 这项申请要求继续为NSABP提供资金，使其继续作为 2001年6月1日至2006年5月31日期间的CCOP研究基地。在.期间 在拟议的授权期内，NSABP将： 1)继续设计和实施多机构癌症治疗和 预防和控制临床试验； 2)分析、报告和发布当前NSABP研究的结果； 3)执行征聘机制和程序，以实现适当的应计 促进妇女和少数民族参与NSABP临床试验； 4)维护数据收集、数据监控和质量控制程序 符合联邦指导方针的； 5)通过持续的质量保证计划监控CCOP的绩效；以及 6)继续将CCOP调查员纳入总体运作 NSABP的。 在完成这些任务时，生物统计学的具体责任 中心将包括：(1)协议和协议的统计和后勤设计 辅助研究；(2)数据库设计和实施；(3) 患者/参与者资格筛选和登记；(4)数据 管理、安保和质量保证；(5)安全、合规和 终点监测；(6)编写治疗和预防数据报告 监测委员会；(7)加快向监管机构报告不良事件 机构；(8)研究数据的统计分析；(9)在 出版摘要和手稿；(X)管理现场审计 方案；(十一)合作进行机构评估；(十二)出版 会员年度进展报告。

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.