DATA MANAGEMENT CENTER--TRIAL OF ORG 10172 IN STROKE

针对数据管理中心(DMC)的竞争延续方案 与一份名为《随机化》的平行提案一起提交 ORG 10172在急性或进展性缺血性中风中的试验提交 同时由哈罗德·P·亚当斯，Jr，M.D. 研究记录在亚当斯博士的提案中。简而言之，一个有希望的 一类称为低分子肝素或类肝素的药物， 它们具有选择性的抗血栓作用，而不需要抗凝剂或 肝素的血小板聚集特性可能在治疗中有效 急性缺血性卒中患者。一种这样的肝素，ORG 10172，是 在这种多中心、随机、双盲、安慰剂中进行测试- 对照试验。主要的假设是，在一个 急性缺血性卒中患者ORG 10172疗效优于 安慰剂提高有利结果的可能性(格拉斯哥) I或II结果量表和Barthel指数12或以上)在三个月时 中风后。总共1300名患者将被随机分配到一个 24天内静脉输注ORG 10172或安慰剂7天 中风发作的小时数。术后对患者进行为期三个月的随访 随机化，或者直到死亡。延长资助期限的主要原因 将继续招募患者至目标样本量，并 进行额外的统计分析。 数据管理中心(DMC)与临床 协调中心(CCC-亚当斯博士的小组)管理试验， 协调试验的生物统计和数据管理方面， 以及监控病人的安全。公积金管理委员会负责提供 各种数据管理服务，包括接收、跟踪、 编辑和更正在26个参与的临床会议上收集的数据 中心(PC)。DMC使用基于Novell的安全个人计算机 用于数据库和文件存储、打印和远程的局域网 通信服务。DMC开发了一个分布式数据条目 这项试验的系统，其中数据是在PCC和 以电子方式传输到DMC。公用事业管理委员会为筹委会提供 个人计算机，并培训学习协调员使用该系统。 数据管理中心定期向项目控制委员会报告逾期数据和 需要更正的数据，向CCC提交有关招聘和付款的 并向美国国立卫生研究院通报试验的进展和安全性。一个 DMC内的医生小组，内部安全委员会， 每月以非盲目的方式审查数据，监测不利的 体验趋势。如果内部安全委员会对 安全，通知NIH安全和监测委员会主席。 DMC执行与该试验相关的所有统计分析， 包括安全分析和正式的中期和最终分析。 由调查员发起的项目控制委员会关于基线分析的请求 吐司数据被转发到DMC，在那里执行分析和 向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.