Center for Innovative NeuroTech Advancement (CINTA) - Evaluation Core

创新神经技术进步中心 (CINTA) - 评估核心

• 批准号: 10707297
• 负责人: STEVEN C. SCHACHTER
• 金额: $ 37.84万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707297
• 关键词: Acceleration; Address; Area; Budgets; Companions; Competence; Diagnosis; Ensure; Evaluation; Family member; Funding; Goals; Grant Review Process; Health; Human; Industry; Infrastructure; Investments; Leadership; Mentors; Methods; Modeling; Monitor; Patients; Peer Review; Persons; Probability; Process; RADx; RADx Tech; Recommendation; Resources; Risk; Technology; Triage; United States National Institutes of Health; Work; equity, diversity, and inclusion; experience; improved; innovation; interest; nervous system disorder; neurotechnology; programs; prototype; response; screening; success; timeline; underserved community

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.

摘要：评估核心 评估核心负责使用严格和透明的流程，将NIH- 有管理的同行评审实践，采用医疗技术行业中成熟的评估方法 收到针对Cinta年度征集的提案。CIMIT在多个领域拥有丰富的经验 申请评估的阶段流程，包括CIMIT博士领导下的神经技术项目。 Schachter的领导力和NIH的快速诊断计划(RADx Tech)。满的数量 这些计划的每次征集收到的申请从30人到700多人不等。辛塔的拱顶 目标是支持最有可能获得商业成功的创新，以解决重大问题 神经系统疾病患者未得到满足的需求。而不是典型的拨款审查过程，即 只根据申请者在其申请中投入的内容来选择项目(“评估和选择”)， 评估核心将使用多阶段审查过程来“评估、改进、选择和促进”子项目。 这遵循了行业和RADx Tech的“漏斗”方法，通过阶段性筛选提案 对那些被认为最有可能成功的人进行评估。评估核心将适应和 改进CIMIT的评估流程，包括在神经技术和 神经系统疾病和有亲身经历的患者和家属。核心意志 通过分流小组、生存小组、深潜团队和深水小组管理应用程序评估流程 潜水面板。每个阶段的建议将提交给Cinta协调小组，然后 指导小组，然后提交给NIH领导层批准。这些阶段包括：1)通过以下方式进行提案前筛选 确定提案是否响应Cinta招标并在蓝图范围内的分流小组 Medtech，2)由一个生存能力小组对邀请的完整提案进行审查，以确定申请是否 解决了NIH参与组织明显未满足的利益需求，并有可能 有Cinta支持的人类级别的原型，3)由经验丰富的导师和 专家协调人在1-3周内与指定的项目团队合作，并进行尽职调查以发现 项目风险，并制定具有现实资金要求和时间表的项目路线图。最终的结果是 为创新者子项目核心创建里程碑驱动的预算和通过/不通过决策点，以 监测并确定一个子项目是否应继续得到Cinta的支持或终止，以及4) 由深度潜水小组审查创新能力，对已确定的未满足需求的潜在影响，团队 能力，以及人类级别的原型是否有可能在拟议的时间表内实现，以及 预算，以及解决方案将如何满足服务不足的社区的需求。专家小组可以建议 批准资助、拒绝或继续深潜。