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联合会（CPIC）的使命是消除疾病负担 与罕见的儿科病毒性疾病相关，重点是先天性巨细胞病毒（CMV）疾病、新生儿 单纯疱疹病毒（HSV）感染和新生儿肠道病毒（EV）和双埃柯病毒（HPeV）败血症， 收集多中心数据，以改善诊断、临床试验准备和治疗。每年，我们将支持 一个为期一年的项目，有助于这一使命，并利用CPIC的优势。 虽然每个试点计划RFA的具体重点将由执行委员会决定，但所有RFA 将强调我们重点疾病领域的创新，并扩大研究合作， CPIC之外。所有CPIC试点项目都将推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。与这次使命一致， 除了财政支助外，试点接受者还将受益于作为项目一部分导师 管理团队旨在确保研究进展，并在开发过程中促进成功 独立研究项目。试点和可行性（P&F）核心的基础设施和活动包括： 旨在：1）确定创新的研究项目，改善诊断，临床试验准备和/或 治疗先天性CMV疾病、新生儿HSV感染或新生儿EV和HPeV脓毒症; 2）鉴定 并支持有前途的初级研究人员谁有兴趣在该地区进行指导研究， 这些罕见疾病;和3）聘请项目管理团队指导试点接受者，并促进他们的 走向独立。 CPIC P&F Core将由Richard J. Whitley博士领导，他成功开发并领导了 亚拉巴马药物发现联盟试点项目。他将与CPIC执行委员会合作， 包括利益相关者代表，以制定年度申请呼吁。CPIC P&F Core将确保 高质量的试点研究，通过赞助竞争的资金，是同行评审和镜像审查 由NIH进行。申请过程将包括初始意向书（LOI），然后是 提交邀请的完整申请。为了审查意向书和选择有价值的申请， 博士惠特利将主持一个由他本人和四名CPIC现场负责人组成的选拔委员会。以允许 扩大我们的投资，项目将有资格获得参与机构的额外支持， 在多地点应用的情况下，将特别鼓励这种机会。一旦获得资金， 将得到多学科项目管理小组的支持，以确保成功完成 项目