University of Rochester Clinical Site within the NEXT Network of Clinical Trials

描述（由申请人提供）：罗切斯特大学（UR）及其神经科学研究人员在神经系统疾病的实验治疗方面有着长期而富有成效的记录。我们目前有39项正在进行的临床试验，涵盖了影响成人和儿童人群的各种常见和罕见疾病。我们有40多名潜在的合作研究者，他们具有临床试验中心研究者的经验， 试验设计和实施各个方面的专业知识。我们的网站资源包括罗切斯特大学的临床和转化科学研究所（UR-CTSI），人类实验治疗中心（CHET），以及我们在实验治疗方面的培训计划。我们是纽约北部神经系统护理的主要提供者，在住院和门诊设置与转诊网络，具有区域，国家和国际影响。我们已经开发了一个领导和监督基础设施，以便灵活，高效和高度完整地实施共享的网络和非网络临床试验。我们已获得机构领导承诺，包括使用中央机构审查委员会（IRB）以及采用和实施主试验协议模板。我们制定了一项全面的计划，以发展和维持与患者团体，当地实践网络和区域转诊资源的关系，以优化招生，招聘和保留，重点是代表性不足的少数民族。我们还制定了培训和指导计划，以确保临床试验人员和协调员的健康渠道，以及详细的质量计划，以促进不断提高的绩效。因此，我们有能力与其他中心和NIH合作，并与数据和临床协调中心合作，实施和开发早期临床试验，涵盖广泛的疾病实体，无论是学术，基础还是行业发现。UR-NEXT研究中心作为NEXT网络的单一中心和成员，可以为神经科学治疗的发展做出重大贡献，并将试验事业提升到一个新的水平。 公共卫生相关性：随机临床试验对于将科学发现转化为改善神经系统疾病患者的健康至关重要。作为临床试验研究中心，罗切斯特大学及其神经科学研究人员拥有实施和开发早期临床试验的经验和专业知识，以改善神经系统疾病患者和家庭的生活。 注：下面以基本上未经编辑的形式提供了来自个人评审员的评论和标准评分。这些文件是在审查会议之前编写的，在会议讨论之后可能没有更新或修订。因此，它们可能不能完全反映小组讨论结束时单个评审员的最终意见或小组的最终多数意见。以上讨论的摘要和总结总结了小组讨论的最终结果。

DESCRIPTION (provided by applicant): The University of Rochester (UR) and its neuroscience investigators have a long and productive track record in the experimental therapeutics of neurological disorders. We currently have 39 ongoing clinical trials covering a broad range of common and rare diseases affecting adult and pediatric populations. We have over 40 potential co-investigators with experience as clinical trial site investigators, as well as expertise in all aspects of trial design and conduct. Our site resources include the University of Rochester's Clinical and Translational Science Institute (UR-CTSI), the Center for Human Experimental Therapeutics (CHET), and our training program in experimental therapeutics. We are a dominant provider of neurological care in Upstate New York in both the inpatient and outpatient settings with referral networks that have regional, national, and international reach. We have developed a leadership and oversight infrastructure to allow for the nimble, efficient and high-integrity implementation of shared Network and non-Network clinical trials. We have secured institutional leadership commitments that include the use of a central Institutional Review Board (IRB) and the adoption and implementation of master trial agreement templates. We have developed a comprehensive plan to develop and sustain relationships with patient groups, local practice networks, and regional referral resources to optimize enrollment, recruitment and retention with an emphasis on underrepresented minorities. We also have in-place training and mentoring plans to ensure a healthy pipeline of clinical trialists and coordinators, as well as a detailed quality plan to promote ever-improving performance. As a result, we are well-positioned to partner with other centers and the NIH, and to work with the Data and Clinical Coordination Centers, to implement and develop early-stage clinical trials, covering a broad range of disease entities, whether from academic, foundation or industry discoveries. The UR-NEXT site, as a single center and member of the NEXT Network, can make major contributions to neuroscience therapeutic development and bring the trial enterprise to a new level. PUBLIC HEALTH RELEVANCE: Randomized clinical trials are essential for the translation of scientific discoveries to improve the health of patients with neurological diseases. As a clinical trial research site, the University of Rochester and its neuroscience investigators have the experience and expertise to implement and develop early-stage clinical trials to improve the lives of patients and families with neurological diseases. NOTE: The critiques and criterion scores from individual reviewers are provided below in an essentially unedited form. These were prepared prior to the review meeting and may not have been updated or revised subsequent to the discussion at the meeting. Therefore, they may not fully reflect the final opinions of the individual reviewers at the close of group discussion or th final majority opinion of the group. The Resume and Summary of Discussion above summarizes the final outcome of the group discussion.