COORD CTR FOR CLIN & EPIDEM STDYS IN INFEC DISEASES

最近宣布的国际儿童疫苗倡议和 对更安全的百日咳疫苗的持续需求实质上 增加了该司支持发展和发展的责任 疫苗测试。反过来，这又要求更好、更有效率 方法通过该司的 疫苗和治疗评价单位网络(VTEU)，特别是 多中心里亚尔。因此，该司设立了一个临床 试验支持协助临床试验所有阶段的工作。 为了实现这一目标，正在授予三份合同。这 合同将支持数据管理、协调和分析，而 第二份合同(RFP#91-36)将由一家工厂制造和 分发测试疫苗和药物，并作为临床研究的资料库 样本，第三份合同(RFP#91-37)将支持临床 监测以及编写和分发议定书和 监管信息。 特别是，本合同的目的是提供一种数据 DMID多中心临床管理协调中心 和/或流行病学研究，包括新的五年临床试验 约60,000名婴儿接种百日咳疫苗，约 另外三项针对传染病的疫苗或治疗试验， 每一次都涉及数百名受试者，大约两年 持续时间。与NIAID支持的临床研究人员和 NIAID项目官员，承包商将以关键方式参与 在每项研究的不同阶段有一个协调中心。这个 承包商的主要责任是：(1)支持该司 及其调查人员具有适当的研究设计，(2)开发和 实施数据管理程序和定制软件程序， 并使用这些工具来输入、更正、汇编和存储研究数据，(3) 监督研究的进行，以确保数据的准确性、完整性和 统一性，(4)提供临时统计分析和及时报告 根据试验期间的规定，(5)协助进行最终数据分析， (六)协助撰写研究成果稿件或其他报告。

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.