Cancer Immunotherapy Trials Network Central Operations and Statistical Center

癌症免疫治疗试验网络（CITN）是一个多机构联盟，专注于测试治疗癌症患者的免疫治疗剂和方法的早期临床试验。CITN的中央运营和统计中心（COSC）将设在弗雷德哈钦森癌症研究中心（FHCRC）。COSC将为全美多达25个成员机构和肿瘤免疫学实验室提供领导和组织资源，包括基础设施、统计支持和方案协调。研究目标包括：（1）创建和管理CITN COSC，以运行领先的研究人员和机构网络，进行早期临床试验，以确定有前途的药物和策略的安全性，毒性和有效性，通过免疫机制预防和治疗癌症;（二）在资助期内启动至少15项I期或早期II期试验，研究免疫逃避的基本机制，（3）将多个肿瘤免疫学实验室纳入CITN，使CITN临床试验的病人样本可用于免疫监测、生物标记物开发和认证，以及促进对临床试验结果背后的生物学机制的理解。一个主要的策略是从广泛的免疫治疗社区中主动选择“最好的”同行评审概念，并利用CITN指导委员会的集体经验来构建“理想的”方案，包括使用难以获得的优先免疫治疗药物。PI和合作研究者联合收割机结合了多中心临床试验实施、早期免疫治疗研究以及药物非临床研究质量管理规范和监查的长期成功历史。CITN将模仿最佳实践，并直接与FHCRC艾滋病毒疫苗试验网络的科学家和管理层合作，该网络是一个进行艾滋病毒相关免疫临床试验的国际联盟。

The Cancer Immunotherapy Trials Network (CITN), a multi-institutional consortium, focuses on early-phase clinical trials that test immunotherapeutic agents and modalities to treat patients with cancer. The Central Operations and Statistical Center (COSC) of the CITN will be based at the Fred Hutchinson Cancer Research Center (FHCRC). The COSC will provide leadership and organizational resources, including infrastructure, statistical support, and protocol coordination, for up to 25 member institutions and tumor immunology laboratories throughout the US. The research goals include: (1) creating and managing the CITN COSC to run a network of leading investigators and institutions to conduct early-phase clinical trials to determine the safety, toxicity, and efficacy of promising agents and strategies to prevent and treat cancer by immune mechanisms; (2) initiating at least 15 phase I or early phase II trials over the course of the funding period that investigate the basic mechanisms of immune evasion and resistance of cancers as an integral part of clinical trials; and (3) integrating a number of tumor immunology laboratories into the CITN to enable the use of specimens obtained from patients on CITN clinical trials for immunomonitoring, biomarker development and credentialing, and facilitating an understanding of the biological mechanisms that underlie the results of the clinical trials. A major strategy will be to proactively choose the "best" peer-reviewed concepts from the broad immunotherapy community and use the collective experience of the CITN Steering Committee to construct "ideal" protocols including use of hard-to-get prioritized immunotherapy agents. The PI and Co-Investigators combine long successful histories of multicenter clinical trial conduct, early-phase immunotherapy research, and good laboratory practice and monitoring. The CITN will model the best practices and collaborate directly with scientists and management of the FHCRC-based HIV Vaccine Trials Network, an international consortium that conducts HIV-related immunotherapeutic clinical trials.