COORD CTR FOR CLIN & EPIDEM STDYS IN INFEC DISEASES

临床坐标点击率

• 批准号: 2295304
• 负责人: MARILYN THOMAS
• 金额: $ 19.77万
• 依托单位: TECHNICAL RESOURCES INTERNATIONAL, INC.
• 依托单位国家: 美国
• 财政年份: 1991
• 资助国家: 美国
• 起止时间: 1991-09-30 至 1996-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2295304
• 关键词: COORD; CTR; CLIN; EPIDEM; STDYS

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.

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基本上 增加了该部门支持发展的责任和 测试疫苗。 反过来，这需要更好，更高效 通过该部门启动和实施临床试验的方法 疫苗和治疗评估单位（VTEU）的网络，特别是 多中心。 因此，该部门已经建立了临床 试验支持协助所有临床试验阶段的工作。 为了实现这一目标，正在授予三个合同。 这 合同将支持数据管理，协调和分析，而 第二份合同（RFP＃91-36）将是一个设施制造的 分发测试疫苗和药物，并用作临床的存储库 标本和第三合同（RFP＃91-37）将支持临床 监视以及协议的准备和分配以及 监管信息。 特别是，本合同的目的是提供数据 管理DMID多个多中心临床的协调中心 和/或流行病学研究，包括新的五年临床试验 大约60,000名婴儿的百日咳疫苗，大约 其他三项疫苗或传染病治疗的试验， 每个涉及几百个受试者和大约两年 期间。与NIAID支持临床研究者和 NIAID项目官员，承包商将以关键方式参加 每个研究的各个阶段期间的协调中心。 这 承包商的主要职责是（1）支持该部门 及其研究人员具有适当的研究设计，（2）开发和 实施数据管理程序和自定义软件程序， 并使用这些输入，纠正，组装和存储研究数据，（3） 监视研究的进行，以确保数据的准确性，完整性和 均匀性，（4）提供临时统计分析和及时报告 如试验期间指定的，（5）协助最终数据分析， （6）协助编写有关研究结果的手稿或其他报告。