Emory Clinical Research Site for NEXT

描述(由申请人提供)：近二十年来，人们一直在关注临床研究中的危机。这一领域持续和日益严重的问题对临床研究的开展产生了不利影响，导致设计、招募和成功完成临床试验失败。造成这种现状的因素有很多，包括科学、教育、伦理、财务和监管问题。一些主要问题包括：1)对许多临床医生、科学家和研究协调员的临床研究培训不足；2)几十年来对临床研究质量的期望越来越高；3)与基础研究相比，在控制潜在混杂因素方面存在更大困难；4)与人的保证和数据保密有关的监管要求增加；5)与利益冲突有关的担忧和监管增加，这涉及到与行业以及非行业相关的个人财务和职业优势的互动；6)预算问题的复杂性；以及7)学术机构为临床试验提供有效支持的困难。进行多中心临床研究试验更具挑战性，因为需要在多个机构反复进行IRB批准和合同谈判。最近，有人呼吁学术机构在临床试验中发挥领导作用。如果没有强有力的学术参与，批评问题将继续得不到解决，重要的试验将不会进行，公共健康将受到影响。NINDS已经认识到限制临床研究进行的问题的严重性，以及这些问题是如何损害将基本科学发现转化为人类群体的。在一种解决现有局限性的创新方法中，NINDS寻求建立神经科学临床试验卓越网络(NEXT)。埃默里大学神经学和亚特兰大地区的合作者寻求作为临床站点参与下一个临床研究网络。我们的团队在各种疾病的神经科学临床研究方面拥有相当多的专业知识，来自不同的地区人口，拥有丰富的主题，以解决多种神经疾病的问题。埃默里大学提供了极好的研究资源，并将对下一个项目做出坚定的承诺，包括同意作为一级站点参与，使用中央IRB，并根据下一届指导委员会和NINDS批准的预算执行协议。

DESCRIPTION (provided by applicant): Concerns over a crisis in clinical research have been raised for almost two decades. Continuing and increasing problems in this area have adversely impacted the conduct of clinical research, leading to failures in design, recruitment and successful completion of clinical trials. Multiple factors contribute to the existing situation, including scientific, educational, ethical, financial, and regulatory issues. Some of the major problems include: 1) inadequate training in clinical research for many clinicians, scientists, and research coordinators; 2) increasing expectations for the quality of clinical research over the las several decades; 3) greater difficulty in the control of potential confounding factors compared to basic research; 4) increased regulatory requirements related to human assurances and confidentiality of data; 5) increased concerns and regulations related to conflicts of interest, which involve interactions with industry as well as non-industry related personal financial and career advantages; 6) increased complexity in budgetary issues; and 7) difficulties with academic institutions providing efficient support for clinical trials. Conduct of multicenter clinial research trials is even more challenging due to the need for repeated IRB approvals and contract negotiations at multiple institutions. Recently, there has been a call for academic institutions to assert leadership in clinical trials. Without vigorous academic involvement, criticl issues will continue to be unaddressed, important trials will not be conducted, and the public health will suffer. The NINDS has recognized the serious nature of problems limiting conduct of clinical research, and how these problems impair the translation of basic scientific findings to human populations. In an innovative approach to address existing limitations, the NINDS seeks to develop a Network for Excellence in Neuroscience Clinical Trials (NEXT). Emory University Neurology and collaborators in the Atlanta area seek to participate as a Clinical Site in the NEXT clinical research network. Our group has considerable expertise in neuroscience clinical research across a wide array of diseases, drawing from a diverse regional population with an abundance of subjects to address issues for multiple neurological disorders. Emory University provides excellent research resources and will make a strong commitment to the NEXT project, including agreeing to participate as a Tier I site using a central IRB and to implement protocols according to the budgets approved by the NEXT Steering Committee and the NINDS.