Congenital and Perinatal Infections Rare Diseases Clinical Research Consortium (RDCRC)

先天性和围产期感染联合会(CPIC)的总体目标是建立基础设施和 机构合作--侧重于罕见的先天性和围产期病毒感染--以增进了解 这些疾病，改善临床试验准备，测试疗法，推进患者护理，并最终减少 疾病负担。这些感染包括先天性巨细胞病毒(CMV)病、新生儿单纯疱疹 肠道病毒(EVS)引起的新生儿病毒性败血症及相关人群 细小病毒(HPev)。 由阿拉巴马大学伯明翰分校(UAB)的研究人员领导，并由一位经验丰富的 高效率的研究团队，将组成CPIC的28个研究地点几十年来一直密切合作 作为协作性抗病毒研究小组(CASG)调查罕见的自然病史和治疗 先天性和围产期传染病。这些长期的关系，以及与 社区和行业利益相关者，将促进我们的研究努力和我们的导师的成功 职业提升活动。与所有成功的研究项目一样，关键问题的答案总是 导致确定将进一步推动该领域发展的下一个重要问题。这些问题是 CPIC研究组合的基础将促进对患有罕见新生儿病毒感染的儿童的护理和 为我们培训未来一代罕见疾病提供体验式指导研究机会 研究人员。 CPIC的目标是：1)在CASG取得的临床研究进展的基础上进一步推进 新生儿单纯疱疹病毒、巨细胞病毒和肠病毒的诊断、治疗和了解；2)利用 与CPIC的28个研究地点和利益相关者建立了长期的关系，以进行临床研究 最忠实于所有研究标准的项目；3)通过分享推动罕见疾病的研究 通过与数据管理和协调中心密切合作并通过 利用云计算能力和公共数据元素；4)开发和使用试点和可行性 提供资金以利用现有的机构资源并最大限度地发挥其对科学进步的影响 与影响新生儿的罕见传染病有关；以及5)支持有指导的研究和职业 为临床研究员和初级教员提供加强机会，以促进早期发展 罕见疾病研究方面的研究人员。我们的联盟将为罕见疾病的临床带来价值 研究网络，通过促进对这些疾病的独特理解，并通过提供经过时间考验的 研究模式和先进的药物计量学专业知识。

The overall goal of the Congenital and Perinatal Infections Consortium (CPIC) is to establish infrastructure and institutional cooperation – focusing on rare congenital and perinatal viral infections – to advance understanding of these diseases, improve clinical trial readiness, test therapies, advance patient care, and ultimately reduce disease burden. These infections include congenital cytomegalovirus (CMV) disease, neonatal herpes simplex virus (HSV) infection, and neonatal viral sepsis caused by enteroviruses (EVs) and the related human parechoviruses (HPeVs). Led by researchers at the University of Alabama at Birmingham (UAB) and supported by an experienced and highly efficient study team, the 28 study sites that will comprise the CPIC have cooperated closely for decades as the Collaborative Antiviral Study Group (CASG) to investigate the natural history and treatment of rare congenital and perinatal infectious diseases. These longstanding relationships, as well as partnerships with community and industry stakeholders, will facilitate the success of our research efforts and our mentored career enhancement activities. As with all successful research programs, answers to critical questions always lead to identification of the next important questions that will further advance the field. These questions are the basis of the CPIC research portfolio that will advance the care of children with rare neonatal viral infections and provide experiential mentored research opportunities as we train the future generation of rare diseases researchers. Aims of the CPIC are: 1) to build upon clinical research advances achieved by the CASG to further advance the diagnosis, treatment, and understanding of HSV, CMV, and EV in the neonatal population; 2) to leverage longstanding relationships across the 28 CPIC study sites and with stakeholders to conduct clinical research projects with the highest of fidelity to all research standards; 3) to advance rare diseases research by sharing standardized data through close partnership with the Data Management and Coordinating Center and by utilizing cloud computing capacities and Common Data Elements; 4) to develop and utilize pilot and feasibility funding to leverage existing institutional resources and maximize its impact on the advancement of the science related to rare infectious diseases impacting neonates; and 5) to support mentored research and career enhancement opportunities for clinical fellows and junior faculty to facilitate the development of early-stage investigators in rare diseases research. Our Consortium will bring value to the Rare Diseases Clinical Research Network by promoting unique understanding of these diseases, and by providing both a time-tested research model and advanced pharmacometric expertise.