Pilot and Feasibility Core

试点和可行性核心

• 批准号: 10001434
• 负责人: RICHARD J. WHITLEY
• 金额: $ 7.72万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10001434
• 关键词: Address; Alabama; Area; Benchmarking; Childhood; Clinical Research; Collaborations; Congenital herpes simplex; Data; Diagnosis Clinical Trials; Disease; Ensure; Enterovirus; Faculty; Financial Support; Funding; Individual; Infrastructure; Infrastructure Activities; Institution; Investments; Knowledge; Letters; Logistics; Mentors; Mission; Movement; Neonatal; Parechovirus; Peer Review; Perinatal Infection; Pilot Projects; Process; Rare Diseases; Readiness; Request for Applications; Research; Research Personnel; Research Project Grants; Sepsis; Simplexvirus; Site; Stress; TimeLine; United States National Institutes of Health; Virus Diseases; Work; burden of illness; congenital cytomegalovirus; congenital infection; design; drug discovery; improved; innovation; interest; multidisciplinary; programs; success

The mission of the Congenital and Perinatal Infections Consortium (CPIC) is to eliminate the disease burden associated with rare pediatric viral diseases focusing on congenital cytomegalovirus (CMV) disease, neonatal herpes simplex virus (HSV) infection, and neonatal enterovirus (EV) and parechovirus (HPeV) sepsis by gathering multi-site data to improve diagnosis, clinical trial readiness, and treatment. Annually, we will support one year-long project that contributes to this mission and utilizes the strengths of the CPIC. Though the specific focus of each Pilot Program RFA will be determined by the Executive Committee, all RFAs will stress innovation in our focused disease areas and extension of research collaborations both within and outside of the CPIC. All CPIC pilot projects will advance knowledge in this important area and will serve as a mentored research opportunity for junior investigators interested in rare diseases. Consistent with this mission, in addition to financial support, pilot recipients will benefit from mentors who serve as part of project management teams designed to ensure research progress and to facilitate success as they develop independent research programs. The infrastructure and activities of the Pilot and Feasibility (P&F) Core are designed to: 1) identify innovative research projects that improve diagnosis, clinical trial readiness and/or treatment for congenital CMV disease, neonatal HSV infection, or neonatal EV and HPeV sepsis; 2) identify and support promising junior investigators who are interested in conducting mentored research in the area of these rare diseases; and 3) engage project management teams to mentor pilot recipients and facilitate their movement toward independence. The CPIC P&F Core will be led by Richard J. Whitley, MD, who has successfully developed and led the Alabama Drug Discovery Alliance pilot program. He will work with the CPIC Executive Committee, which includes stakeholder representation, to craft an annual call for applications. The CPIC P&F Core will ensure high-quality pilot research by sponsoring a competition for funding that is peer-reviewed and mirrors reviews conducted by the NIH. The application process will include an initial letter of intent (LOI), followed by submission of invited, full applications. For the review of LOIs and the selection of meritorious applications, Dr. Whitley will chair a Selection Committee comprised of himself and four CPIC site leads. To allow for expansion of our investment, projects will be eligible to receive additional support from participating institutions, an opportunity that will be especially encouraged in the case of multi-site applications. Once funded, projects will receive support from multidisciplinary project management teams to ensure successful completion of projects.

先天性和围产期感染财团（CPIC）的任务是消除疾病负担 与罕见的小儿病毒疾病有关，重点是先天性巨细胞病毒（CMV）疾病，新生儿 通过 收集多站点数据以改善诊断，临床试验准备和治疗。每年，我们将支持 为这项任务做出贡献并利用CPIC的优势的一个为期一年的项目。 尽管每个试点计划的具体重点RFA将由执行委员会确定，但所有RFA 将强调我们重点疾病领域的创新以及内部和内部研究合作的扩展 在CPIC之外。所有CPIC飞行员项目都将推进这一重要领域的知识，并将作为一个 为对罕见疾病感兴趣的初级调查人员提供了指导的研究机会。与此任务一致 除了财政支持之外，飞行员接收者还将受益于作为项目一部分的导师 旨在确保研究进展并促进成功的管理团队 独立研究计划。飞行员和可行性（P＆F）核心的基础设施和活动是 设计为：1）确定改善诊断，临床试验准备和/或的创新研究项目 治疗先天性CMV疾病，新生儿HSV感染或新生儿EV和HPEV败血症； 2）识别 并支持有前途的初级调查员，他们有兴趣在该领域进行指导的研究 这些罕见的疾病； 3）聘请项目管理团队来指导飞行员接收者并促进他们的 朝着独立发展。 CPIC P＆F核心将由医学博士Richard J. Whitley领导，他成功地开发并领导了 阿拉巴马州药物发现联盟试点计划。他将与CPIC执行委员会合作，该委员会 包括利益相关者代表，以每年的申请呼吁。 CPIC P＆F核心将确保 高质量的飞行员研究通过赞助一项经过同行评审的资金竞赛，并镜子评论 由NIH进行。申请过程将包括意向的首字母（LOI），然后包括 提交邀请，全面申请。为了审查路易斯和选择有功申请的选择， 惠特利博士将主席由自己和四个CPIC网站主角组成的选拔委员会主席。允许 扩展我们的投资，项目有资格获得参与机构的额外支持， 在多站点申请的情况下，这将受到特别鼓励的机会。一旦资助，项目 将获得多学科项目管理团队的支持，以确保成功完成 项目。