Clinical Onology Program Biostatistical Center

临床肿瘤学项目生物统计中心

• 批准号: 7255237
• 负责人: JOSEPH P. COSTANTINO
• 金额: $ 89.19万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-09-01 至 2007-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7255237
• 关键词: behavioral /social science research tag; breast neoplasms; breast surgery; cancer prevention; chemoprevention; clinical research; clinical trials; colorectal neoplasms; combination cancer therapy; combination chemotherapy; community health services; continuing education; cooperative study; data collection methodology /evaluation; female; human subject; human therapy evaluation; information dissemination; neoplasm /cancer chemotherapy; neoplasm /cancer education; neoplasm /cancer surgery; neoplasm /cancer therapy; statistical service /center; statistics /biometry; tamoxifen; therapy compliance

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.

描述：（申请人的描述）国家外科辅助乳房 肠道项目（NSABP）是NCI资助的临床试验合作小组 致力于癌症治疗和预防控制研究40年 进行大规模对照试验的历史。 1992 年，国家安全局 扩大了其研究议程，将癌症预防试验纳入其中。美国国家安全局 自1983年CCOP项目启动以来一直是CCOP研究基地， 目前有 54 个 CCOP 将 NSABP 列为其研究基地。慢性阻塞性肺疾病 大量参与 NSABP 治疗和预防试验； 大约 38% 的 NSABP 应计费用归因于 CCOP 调查员。 该申请请求继续为 NSABP 提供资金，以继续作为 CCOP研究基地的期限为2001年6月1日至2006年5月31日。 在拟议的资助期内，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 研究结果； 3）实施招聘机制和程序以实现足够的应计费用 促进妇女和少数族裔参与 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； 5) 通过持续的质量保证计划监控 CCOP 绩效；和 6) 继续将 CCOP 调查员纳入整体运作 NSABP 的。 在完成这些任务时，生物统计部门的具体职责 中心将包括：（I）协议的统计和后勤设计以及 辅助研究； (ii) 数据库设计和实施； (三) 患者/参与者资格筛选和注册； (四) 数据 管理、安全和质量保证； (v) 安全、合规和 终点监测； (vi) 准备治疗和预防数据报告 监督委员会； (vii) 加快向监管机构报告不良事件 机构； (viii) 研究数据的统计分析； (九) 合作 出版摘要和手稿； (x) 管理现场审核 程序; (xi) 在机构评价方面进行合作； (十二) 出版 向会员提交的年度进度报告。