DATA MANAGEMENT CENTER--TRIAL OF ORG 10172 IN STROKE

这是一个数据管理中心（DMC）的竞争性延续提案， 与题为“随机化”的平行提案一起提交 ORG 10172在急性或进展性缺血性卒中中的试验”提交 同时由哈罗德·P·亚当斯，小，M.D.临床方面， 研究都记录在亚当斯博士的提案中。简而言之，一个有前途的 一类叫做低分子量肝素，或类肝素， 其在没有抗凝剂的情况下具有选择性抗血栓形成作用， 肝素的血小板聚集特性，可能是有效的治疗 急性缺血性卒中患者。一种这样的类肝素，ORG 10172， 在这个多中心，随机，双盲，安慰剂中进行测试， 对照试验主要假设是，在一个人口 急性缺血性卒中患者，ORG 10172比 安慰剂改善有利结局的可能性（格拉斯哥 3个月时结局量表I或II，Barthel指数为12或以上 中风后共有1300名患者将被随机分配至 在24小时内静脉输注ORG 10172或安慰剂7天 中风发作的时间患者随访3个月后， 随机化或直至死亡。延长供资的主要原因 继续招募患者至目标样本量， 进行额外的统计分析。 数据管理中心（DMC）与临床 协调中心（CCC -亚当斯博士小组）管理试验， 协调试验的生物统计学和数据管理方面， 并监测患者安全。DMC负责提供 各种数据管理服务，包括接收，跟踪， 编辑和纠正在26个参与临床试验机构收集的数据。 中心（PCC）。DMC使用基于Novell的安全个人计算机 局域网，用于数据库和文件存储、打印和远程 通信服务。DMC开发了分布式数据输入 本试验的系统，其中数据在PCC上以双键输入， 以电子方式发送到DMC。DMC为PCC提供 个人电脑，并培训学习协调员使用该系统。 DMC定期向PCC提供有关逾期数据的报告， 需要更正的数据，关于招聘和支付CCC 处理，以及NIH关于试验的进展和安全性。一 DMC内的医生组，内部安全委员会， 每月以非盲方式审查数据，监测不良反应 体验趋势。如果内部安全委员会担心 安全性，通知NIH安全和监测委员会主席。 DMC执行与本试验相关的所有统计分析， 包括安全性分析和正式的中期和最终分析。 调查者主动提出的来自PCC的基线分析请求 将吐司数据转发给DMC，在DMC中进行分析， 为当地提供统计指导和解释， 调查员

This competing continuation proposal for a Data Management Center (DMC) is submitted in conjunction with a parallel proposal entitled "Randomized Trial of ORG 10172 in Acute or Progressing Ischemic Stroke" submitted simultaneously by Harold P. Adams, Jr., M.D. The clinical aspects of this research are documented in Dr. Adams' proposal. Briefly, a promising class of drugs called low molecular weight heparins, or heparinoids, which have selective antithrombotic effects without the anticoagulant or platelet-aggregating properties of heparin, may be effective in treating patients with acute ischemic stroke. One such heparinoid, ORG 10172, is being tested in this multi-center, randomized, double-blind, placebo- controlled trial. The primary hypothesis is that, in a population of patients with acute ischemic stroke, ORG 10172 is more efficacious than placebo in improving the likelihood of a favorable outcome (Glasgow Outcome Scale of I or II and Barthel Index of 12 or more) at three months after stroke. A total of 1300 patients will be randomly assigned to a seven-day intravenous infusion of either ORG 10172 or placebo within 24 hours of stroke onset. Patients are followed for three months post randomization, or until death. The primary reasons for extending funding are to continue patient enrollment to the target sample size, and to conduct additional statistical analyses. The Data Management Center (DMC) works closely with the Clinical Coordinating Center (CCC - Dr. Adams' group) in managing the trial, coordinating the biostatistical and data management aspects of the trial, and monitoring patient safety. The DMC is responsible for providing a variety of data management services, including receiving, tracking, editing, and correcting data collected at the 26 Participating Clinical Centers (PCCs). The DMC uses a secure, personal computer based Novell local area network for data base and file storage, printing, and remote communications services. The DMC developed a distributed data entry system for this trial, whereby data are double-key entered at the PCC and electronically transmitted to the DMC. The DMC provides the PCCs with personal computers, and trains study coordinators in using the system. The DMC provides regular reports to the PCCs regarding overdue data and data requiring correction, to the CCC regarding recruitment and payment processing, and to NIH regarding progress and safety in the trial. A group of physicians within the DMC, the In-House Safety Committee, reviews data monthly in an unblinded fashion, monitoring adverse experience trends. If the In-House Safety Committee has concerns about safety, the chair of the NIH Safety and Monitoring Committee is notified. The DMC performs all statistical analyses associated with this trial, including safety analyses and formal interim and final analyses. Investigator-initiated requests from the PCCs for analyses of baseline TOAST data are forwarded to the DMC, where analyses are performed and statistical guidance and interpretation are offered to the local investigator.