NEW ENGLAND PROGRAM FOR AIDS CLINICAL TRIALS-PROACT (CPC

我们建议在新英格兰南部开展区域性临床试验项目，作为新的CPCRA站点。新英格兰艾滋病临床试验项目（ProACT）是康涅狄格州纽黑文耶鲁大学医学院、布朗大学、罗德岛州普罗维登斯纪念医院和马萨诸塞州波士顿社区研究倡议等现有临床试验点合作的产物。ProACT将通过以下方式为CPCRA的科学议程做出贡献：1)增加三个站点的CPCRA专家和忠诚的临床研究者，他们将积极参与地方和国家层面的CPCRA；2)为CPCRA长期策略试验的招募、入组和保留提供大量和多样化的艾滋病毒感染者；3)在一些与CPCRA科学议程相关的领域提供专业知识，包括依从性，药理学，免疫治疗，成本效益分析。ProACT将由三个主要站点组成，每个站点都有紧密相连的子站点或附属站点。程序和结构，以确保有效的治理，标准化的研究实践，质量保证和密切的沟通在ProACT创建一个强大的，科学的和临床合理的CPCRA临床试验项目。在三个ProACT站点中，我们将在本资助期间的任何给定时间根据研究方案招募和跟踪200名患者。

We propose a regional clinical trials program in southern New England as a new CPCRA site. The New England Program for AIDS Clinical Trials (ProACT) is the product of a collaboration among existing clinical trials sites at Yale University School of Medicine in New Haven, Connecticut, Brown University and Memorial Hospital in Providence, Rhode Island and Community Research Initiative in Boston, Massachusetts. ProACT will contribute to the scientific agenda of the CPCRA by: 1) adding to the CPCRA expert and committed clinical investigators at the three sites who will actively participate at the local and national levels; 2) providing a large and diverse population of people with HIV disease for recruitment, enrollment and retention in CPCRA long- term strategy trials; 3) contributing expertise in a number of areas relevant to the CPCRA scientific agenda, including adherence, pharmacology, immune based therapies, cost effectiveness analysis. ProACT will consist of three principal sites, each with tightly linked sub-sites or affiliates. Procedures and structures to ensure effective governance, standardization of research practice, quality assurance and close communication within ProACT have been developed to create a strong and scientifically and clinically sound CPCRA clinical trials program. Among the three ProACT sites we will enroll and follow 200 patients on study protocols at any given time over the course of this grant.