Pilot and Feasibility Core

试点和可行性核心

• 批准号: 10248361
• 负责人: RICHARD J. WHITLEY
• 金额: $ 12.37万
• 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 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10248361
• 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; 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; clinical trial readiness; 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联盟 (CPIC) 的使命是消除疾病负担 与罕见的儿科病毒性疾病相关，重点关注先天性巨细胞病毒 (CMV) 疾病、新生儿 单纯疱疹病毒 (HSV) 感染以及新生儿肠道病毒 (EV) 和副肠病毒 (HPeV) 败血症 收集多站点数据以改善诊断、临床试验准备和治疗。每年我们都会支持 为期一年的项目，为这一使命做出贡献，并利用太保的优势。 尽管每个试点计划 RFA 的具体重点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外部研究合作的扩展 CPIC 之外。所有 CPIC 试点项目都将增进这一重要领域的知识，并将作为 为对罕见疾病感兴趣的初级研究人员提供指导研究机会。与这一使命相一致， 除了财政支持外，试点受益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研究成功的管理团队 独立研究计划。试点和可行性 (P&F) 核心的基础设施和活动是 旨在：1）确定可改善诊断、临床试验准备和/或的创新研究项目 先天性 CMV 疾病、新生儿 HSV 感染或新生儿 EV 和 HPeV 败血症的治疗； 2）识别 并支持有兴趣在该领域进行指导研究的有前途的初级研究人员 这些罕见疾病； 3) 让项目管理团队指导试点接受者并促进他们的工作 走向独立的运动。 CPIC P&F 核心将由医学博士 Richard J. Whitley 领导，他成功开发并领导了 阿拉巴马州药物发现联盟试点计划。他将与太保执行委员会合作， 包括利益相关者代表，以制定年度申请征集。 CPIC P&F 核心将确保 通过赞助经过同行评审和反映评论的资助竞赛来开展高质量的试点研究 由美国国立卫生研究院 (NIH) 进行。申请流程将包括初始意向书 (LOI)，然后是 提交受邀请的完整申请。对于意向书的审查和优秀申请的选择， 惠特利博士将主持一个由他本人和四名太保现场负责人组成的评选委员会。为了允许 扩大我们的投资，项目将有资格获得参与机构的额外支持， 在多站点应用程序的情况下，这是一个特别值得鼓励的机会。一旦获得资助，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。