Network for Excellence in Neuroscience Clinical Trials Center at The Ohio State University

俄亥俄州立大学神经科学临床试验中心卓越网络

• 批准号: 10593650
• 负责人: Stephen J. Kolb
• 金额: $ 30.87万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10593650
• 关键词: Adult; Advocacy; Advocate; Affect; Age-Months; Area; Biometry; Child; Childhood; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Collaborations; Data; Development; Development Plans; Diagnosis; Educational Curriculum; Enrollment; Fellowship; Five-Year Plans; Funding; Future; Grant; Human Resources; Individual; Infant; Influentials; Infrastructure; Investments; K-Series Research Career Programs; Leadership; Link; Medical center; Mentors; Mentorship; Morals; Motor Neuron Disease; National Institute of Neurological Disorders and Stroke; Natural History; Neurologic; Neurology; Neurosciences; Nursery Schools; Ohio; Patients; Pediatric Hospitals; Performance; Phase; Physicians; Principal Investigator; Protocols documentation; Randomized; Research; Research Institute; Research Personnel; Site; Spinal Muscular Atrophy; Time; TimeLine; Training; Training and Infrastructure; United States National Institutes of Health; Universities; Update; career development; clinical center; cohort; design; expectation; experience; innovation; interest; nervous system disorder; outreach; programs; recruit; success

The Network of Excellence in Neuroscience Clinical Trial Center at The Ohio State University is one of the original NeuroNEXT centers and maintains a strong commitment and enthusiasm for the network. Our center, comprised of physician investigators at The Ohio State University Wexner Medical Center (OSUWMC) and Nationwide Children's Hospital (NCH), has contributed substantially to the success of NeuroNEXT and is one of the few centers selected to enroll in all eight funded studies. Membership in NeuroNEXT has had a meaningful impact for Ohio State Neurology by providing our patients with important new opportunities for research participation and contributing to a programmatic cultural shift towards more investigator-initiated NIH- funded clinical studies. Ohio State Neurology was a leader in multiple important performance metrics, including the number of randomized or confirmed subjects (top site), efficiency in starting new trails (third fastest) and data accuracy (fourth). We build upon our success to maintain and optimize our NeuroNEXT infrastructure. The leadership administration will be simplified to consist of four key personnel. Collaboration within the our NeuroNEXT Center will be coordinated between site leadership and a large pool of experienced, reliable and motivated potential co-investigators that span all areas of clinical neuroscience. We will build upon the innovative, multifaceted approach to recruitment and outreach that has made us the most successful recruiting site in NeuroNEXT. We will extend our emphasis on research coordinator advocacy with the creation of a Research Coordinator Recognition Program. We will increase the oversight between the NeuroNEXT leadership and each active study team during the course of each study. We energetically support the emphasis on career development in the next cycle of NeuroNEXT. We will implement the NeuroNEXT Clinical Trial Fellowship to expand the pool of experienced clinical investigators and research staff who will be leaders of multicenter clinical research trials. The NeuroNEXT Fellow at OSU will be required to submit a clinical study proposal to the NeuroNEXT Network by the end of the two-year Fellowship period. Clear expectations and milestone requirements will be made and formalized in an Individual Development Plan (IDP) detailing curriculum and training timelines. A mandatory mentorship committee will be formed consisting of NeuroNEXT leadership, a primary mentor and a biostatistician provided by the OSU Neurological Research Institute to help support the development of Fellow projects. The IDP will be updated and reviewed quarterly by a mentorship committee and curriculum will link to existing training infrastructure at OSUWMC and NINDS. In the second year, a “Five Year Plan” for the next phase of protected training time will be formalized that is integrated with existing pre-K and K award opportunities. Thus, NeuroNEXT Fellows will have a high likelihood to sustain their momentum and successfully transition to an independent, funded and productive clinical trialist.

俄亥俄州州立大学的神经科学临床试验卓越网络中心是最初的NeuroNEXT中心之一，并对网络保持着强烈的承诺和热情。我们的中心由俄亥俄州州立大学韦克斯纳医学中心（OSUWMC）和全国儿童医院（NCH）的医生研究人员组成，为NeuroNEXT的成功做出了重大贡献，是少数几个入选所有八项资助研究的中心之一。NeuroNEXT的会员资格为俄亥俄州州立神经病学带来了有意义的影响，为我们的患者提供了参与研究的重要新机会，并促进了向更多由美国国立卫生研究院资助的临床研究的计划文化转变。俄亥俄州州立神经病学在多个重要的性能指标方面处于领先地位，包括随机或确认的受试者数量（顶级网站），启动新试验的效率（第三快）和数据准确性（第四）。我们在成功的基础上维护和优化我们的NeuroNEXT基础设施。领导管理将简化为由四个关键人员组成。我们的NeuroNEXT中心内的合作将在研究中心领导层和大量经验丰富，可靠和积极的潜在合作研究者之间进行协调，这些合作研究者涵盖临床神经科学的所有领域。我们将建立在创新的，多方面的招聘和推广方法，使我们成为NeuroNEXT最成功的招聘网站。我们将扩大我们对研究协调员的倡导与研究协调员认可计划的创建重点。我们将在每项研究过程中加强NeuroNEXT领导层与每个活跃研究团队之间的监督。我们大力支持NeuroNEXT下一个周期对职业发展的重视。我们将实施NeuroNEXT临床试验奖学金，以扩大经验丰富的临床研究者和研究人员的人才库，他们将成为多中心临床研究试验的领导者。在俄勒冈州立大学的NeuroNEXT研究员将被要求提交一份临床研究提案到NeuroNEXT网络的两年奖学金期结束。明确的期望和里程碑要求将在个人发展计划（IDP）中制定和正式化，详细说明课程和培训时间表。将成立一个强制性的导师委员会，由NeuroNEXT领导，主要导师和OSU神经研究所提供的生物统计学家组成，以帮助支持研究员项目的发展。指导委员会将每季度更新和审查IDP，课程将与OSUWMC和NINDS的现有培训基础设施联系起来。在第二年，将正式制定下一阶段受保护培训时间的“五年计划”，该计划将与现有的K前和K奖励机会相结合。因此，NeuroNEXT研究员将有很大的可能性来维持他们的势头，并成功地过渡到一个独立的，资助和富有成效的临床试验。