NEW ENGLAND PROGRAM FOR AIDS CLINICAL TRIALS-PROACT (CPC

我们建议在新英格兰南部建立一个地区性临床试验计划，作为CPCRA的新站点。新英格兰艾滋病临床试验计划(PRACT)是康涅狄格州纽黑文的耶鲁大学医学院、罗德岛州普罗维登斯的布朗大学和马萨诸塞州波士顿的社区研究计划的现有临床试验地点合作的产物。Proact将通过以下方式为CPCRA的科学议程做出贡献：1)增加CPCRA的专家和三个地点的坚定临床研究人员，他们将在地方和国家一级积极参与；2)为招募、登记和保留CPCRA长期策略试验的大量和多样化的艾滋病毒疾病患者提供专业知识；3)在与CPCRA科学议程相关的一些领域提供专业知识，包括依从性、药理学、免疫疗法、成本效益分析。Proact将由三个主要网站组成，每个网站都有紧密联系的子网站或附属网站。已经制定了程序和结构，以确保有效的治理、研究实践的标准化、质量保证和Proact内部的密切沟通，以创建一个强大的、科学的和临床上健全的CPCRA临床试验计划。在Proact的三个站点中，我们将在此赠款过程中的任何给定时间招募并跟踪200名患者进行研究。

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.