COORD CTR FOR CLIN & EPIDEM STDYS IN INFEC DISEASES

最近宣布的国际儿童疫苗倡议和 对更安全百日咳疫苗的持续需求 增加了该司支持发展的责任， 测试疫苗。 反过来，这需要更好、更有效的 发起和实施临床试验的方法 疫苗和治疗评价单位网络，特别是 多中心rials。 因此，该司设立了一个临床 试验支持努力协助临床试验的各个阶段。 为了实现这一目标，正在授予三项合同。 这 合同将支持数据管理、协调和分析， 第二份合同（RFP #91 - 36）将是一个设施， 分发试验疫苗和药物，并作为临床 第三份合同（RFP #91 - 37）将支持临床 监测、编写和分发方案， 监管信息。 特别是，本合同的目的是提供数据 协调中心，负责管理DMID的多中心临床 和/或流行病学研究，包括一项为期五年的新的 约60，000名婴儿接种百日咳疫苗， 另外三项关于传染病疫苗或治疗的试验， 每一个都涉及几百个受试者， 持续时间与NIAID合作，支持临床研究者和 NIAID项目官员，承包商将以关键方式参与， 在每个研究的各个阶段都有一个协调中心。 的 承包商的主要职责是（1）支持事业部 （2）研究人员采用适当的研究设计， 实施数据管理程序和定制软件程序， 并使用这些输入，校正，组装和存储研究数据，（3） 监测研究的进行，以确保数据的准确性、完整性和 统一性，（4）提供中期统计分析和及时报告 按照试验期间的规定，（5）协助进行最终数据分析， （6）协助撰写研究结果的稿件或其他报告。

The recently announced international Children's Vaccine Initiative and the persisting demand for a safer pertussis vaccine have substantially increased the Division's responsibility for supporting development and testing of vaccines. In turn this requires better, more efficient methods to initiate and implement clinical trials through the Division's network of Vaccine and Treatment Evaluation Units (VTEUs), particularly multicenter rials. The Division has therefore established a Clinical Trials Support Effort to assist with all phases of clinical trials. Three contracts are being awarded in order to accomplish this goal. This contract will support data management, coordination, and analysis, while a second contract (RFP #91-36) will be for a facility to make and distribute test vaccines and drugs and serve as a repository for clinical specimens, and a third contract (RFP #91-37) will support clinical monitoring and the preparation and distribution of protocol and regulatory information. In particular, the purpose of this contract is to provide a Data Coordinating Center for managing several of DMID's multicenter clinical and/or epidemiologic studies, including a five year clinical trial of new pertussis vaccines in approximately 60,000 infants and approximately three other trials of vaccines or treatments for infectious diseases, each involving a few hundred subjects and of approximately two years duration. Working with NIAID supported clinical investigators and the NIAID Project Officers, the Contractor will participate in a key way as a coordinating center during the various phases of each study. The Contractor's major responsibilities will be to (1) support the Division and its investigators with appropriate research design, (2) develop and implement data management procedures and customized software programs, and use these to enter, correct, assemble and store study data, (3) monitor the conduct of studies to ensure data accuracy, integrity and uniformity, (4) provide interim statistical analyses and timely reports as specified during the trials, (5) assist in the final data analysis, and (6) assist in writing manuscripts or other reports on study results.