Center for Innovative NeuroTech Advancement (CINTA) - Evaluation Core

摘要：评价核心 评估核心负责使用严格和透明的流程，这些流程结合了联合收割机的最佳NIH- 管理同行评审实践，采用医疗技术行业中用于评估的成熟方法 在CINTA年度招标中收到的提案。CIMIT拥有丰富的经验， 阶段的应用程序，包括CIMIT的神经技术计划下博士的评估过程。 Schachter的领导和NIH的快速加速诊断计划（RADx Tech）。满数 这些方案每次征集收到的申请从30份到700多份不等。CINTA的首要任务 我们的目标是支持最有可能取得商业成功的创新，以解决重大的 神经系统疾病患者的需求未得到满足。而不是典型的赠款审查过程， 只根据申请人在申请中的内容选择项目（“评估和选择”）， 评价核心将采用多阶段审查程序来“评估、改进、选择和促进”子项目。 这遵循了行业和RADx技术的“漏斗”方法，通过分阶段筛选提案 评价对象是那些被认为最有可能成功的人。评价核心将进行调整， 改进CIMIT的评估流程，包括在神经技术方面具有广泛能力的专家， 神经系统疾病患者及有亲身经历的家属。芯会 通过分类小组、可行性小组、深入研究小组和深入研究小组管理应用程序评估过程。 潜水面板。每个阶段的建议将提交给CINTA协调小组， 指导委员会，然后向NIH领导批准。这些阶段包括：1）由一个 分类小组，以确定该提案是否符合CINTA的要求，并在蓝图的范围内 医疗技术，2）由可行性小组审查邀请的完整提案，以确定申请是否 解决了NIH参与组织感兴趣的明确未满足的需求，并有可能达到 由CINTA支持的人类级原型，3）由经验丰富的导师组成的深度潜水团队， 专家协调员与指定的项目团队合作1-3周，并进行尽职调查，以发现 项目风险，并创建具有现实资金需求和时间表的项目路线图。最终结果是 为创新子项目核心创建里程碑驱动的预算和进行/不进行决策点， 监控并确定子项目是否应继续获得CINTA支持或终止，以及4） 由深潜小组审查创新性、对已确定的未满足需求的潜在影响、团队 能力，以及是否有可能在拟议的时间轴内实现人类级原型， 预算，以及解决方案将如何满足服务不足社区的需求。小组可以建议 批准资金，拒绝或继续深潜。

Abstract: EVALUATION CORE The Evaluation Core is responsible for using rigorous and transparent processes that combine the best of NIH- managed peer review practices with well-established methods used in the medtech industry for evaluating proposals received in response to CINTA annual solicitations. CIMIT has extensive experience with multi- stage processes for the evaluation of applications, including for CIMIT’s NeuroTechnology Program under Dr. Schachter’s leadership, and NIH’s Rapid Acceleration of Diagnostics Program (RADx Tech). The number of full applications received per solicitation for these programs has ranged from 30 to over 700. CINTA’s overarching goal is to support innovations that have the greatest probability of commercial success to solve significant unmet needs for persons with nervous system disorders. Instead of the typical grant review process that selects projects based only on what the applicant puts into their applications (“evaluate and select”), the Evaluation Core will use a multi-stage review process to “assess, improve, select, and facilitate” subprojects. This follows the “funnel” approach of industry and RADx Tech to winnow down proposals through staged evaluations to those judged to have the greatest likelihood of success. The Evaluation Core will adapt and improve CIMIT’s evaluation processes including experts with broad competencies in neurotechnologies and disorders of the nervous system and patients and family members with personal experiences. The Core will manage the application evaluation process with a Triage Panel, Viability Panel, Deep Dive teams, and a Deep Dive Panel. Recommendations from each stage will be presented to the CINTA Coordination Team, then the Steering Panel and then to NIH leadership for approval. These stages include: 1) pre-proposal screening by a Triage Panel to determine if the proposal is responsive to the CINTA solicitation and within scope for Blueprint MedTech, 2) review of invited full proposals by a Viability Panel to determine whether the application addresses a clear unmet need of interest to the NIH Participating Organizations and has the potential to reach a human-grade prototype with CINTA support, 3) A Deep Dive Team consisting of experienced mentors and expert facilitators to work with assigned project teams over 1-3 weeks and conduct due diligence to uncover project risks and create a project roadmap with realistic funding requirements and timelines. The end-result is creation of milestone-driven budgets and Go/No-go decision points for the Innovator Subprojects Core to monitor and determine whether a subproject should continue with CINTA support or be terminated, and 4) review by the Deep Dive Panel for innovativeness, potential impact on identified unmet needs, team capabilities, and whether a human-grade prototype can likely be achieved within the proposed timeline and budget, and how the solution will address the needs of underserved communities. The Panel can recommend approval for funding, rejection, or continuation of the deep dive.