Emory Clinical Research Site for NEXT

描述（由申请人提供）：对临床研究危机的关注已经提出了近二十年。这一领域不断增加的问题对临床研究的开展产生了不利影响，导致临床试验设计、招募和成功完成的失败。多种因素导致了这种现状，包括科学、教育、伦理、金融和监管问题。一些主要问题包括：1)许多临床医生、科学家和研究协调员在临床研究方面的培训不足；2)在过去的几十年里，对临床研究质量的期望越来越高；3)与基础研究相比，潜在混杂因素的控制难度较大；4)增加了与人为保证和数据机密性相关的监管要求；5)与利益冲突相关的担忧和法规增加，包括与行业的互动以及与行业无关的个人财务和职业优势；6)预算问题日益复杂；7)学术机构难以为临床试验提供有效支持。由于需要在多个机构进行反复的IRB批准和合同谈判，多中心临床研究试验的开展更具挑战性。最近，有人呼吁学术机构在临床试验中发挥领导作用。没有积极的学术参与，关键问题将继续得不到解决，重要试验将无法进行，公共卫生将受到影响。NINDS已经认识到限制临床研究行为的问题的严重性，以及这些问题如何损害基本科学发现向人类的转化。在解决现有限制的创新方法中，NINDS寻求发展神经科学临床试验卓越网络（NEXT）。埃默里大学神经病学和亚特兰大地区的合作者寻求作为NEXT临床研究网络的临床站点参与。我们的团队在广泛疾病的神经科学临床研究方面拥有相当多的专业知识，来自不同地区的人群，具有丰富的主题来解决多种神经系统疾病的问题。埃默里大学提供优秀的研究资源，并将对NEXT项目做出强有力的承诺，包括同意作为使用中央IRB的一级站点参与，并根据NEXT指导委员会和NINDS批准的预算实施协议。

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.