CCTSI Participation in the National COVID Cohort Collaborative (N3C)

项目摘要/摘要 本申请由科罗拉多州临床和翻译科学研究所(CCTSI；UL1)提交 TR002535)响应NOT-TR-20-028，临床和翻译科学奖(CTSA)计划 满足2019年新型冠状病毒(新冠肺炎)公共卫生需求的申请，以及PA-18-591，行政 美国国立卫生研究院现有拨款和合作协议的补充。 新冠肺炎疫情产生了前所未有的全球影响。在一些患者中，SARS-CoV-2感染导致 肺炎、高炎症、低氧性呼吸衰竭、急性呼吸窘迫综合征、多发性 器官功能障碍综合症和死亡。尽管在确定疾病风险因素方面取得了快速进展 严重新冠肺炎，目前还没有FDA批准的SARS-CoV-2疫苗，只有一种紧急FDA- 批准的治疗方法(瑞德韦)。大多数美国关于新冠肺炎的临床特征、治疗和治疗的报道 结果来自单一医院或卫生系统，或仅提供所获得的汇总统计数据 使用联邦查询设计。这一领域的进展因缺乏大型、 用于开发和测试的集中式多中心、行级、高粒度临床数据资源 并开发新的预测和诊断计算工具。因此，有一种迫切的公共需求 健康需要构建这样一个集中化的资源。 这份UL1行政补充文件的具体目的是：1.构建深层次、适应性强的新冠肺炎临床 数据集市。我们将利用CCTSI Informatics Core和我们的企业数据仓库来创建COVID- 19个数据集市，将包括从大型成年人和 儿科保健系统。我们将使数据集市符合N3C首选的通用数据模型 观察性医疗结果伙伴关系(OMOP)模型。2.分享中旅新冠肺炎案及控管 与N3C的数据。我们将确保适当的监管批准和数据传输协议，并安全地 将协调一致的新冠肺炎数据转移到N3C。3.共同领导N3C临床方案和分析。作为世界上 仅在CTSA信息学企业委员会、CCTSI信息学核心中执业的ICU医生 主任Tellen Bennett博士将通过聘请其他临床医生-科学家和领先的 临床分析的轻重缓急和执行。总而言之，这些努力将加速临床和数据 科学研究以开发更好的治疗方案以及预测和诊断工具 新冠肺炎。

PROJECT SUMMARY/ABSTRACT This application is being submitted by the Colorado Clinical and Translational Sciences Institute (CCTSI; UL1 TR002535) in response to NOT-TR-20-028, Clinical and Translational Science Award (CTSA) Program Applications to Address 2019 Novel Coronavirus (COVID-19) Public Heath Need, and PA-18-591, Administrative Supplements to Existing NIH Grants and Cooperative Agreements. The COVID-19 pandemic has had unprecedented global impact. In some patients, SARS-CoV-2 infection leads to pneumonia, hyperinflammation, hypoxemic respiratory failure, acute respiratory distress syndrome, multiple organ dysfunction syndrome, and death. Although rapid advances have been made in identifying risk factors for severe COVID-19, there are currently no FDA-approved SARS-CoV-2 vaccines and only one emergency FDA- approved therapeutic (remdesivir). Most U.S. reports of COVID-19 clinical characteristics, treatments, and outcomes have been from a single hospital or health system or have presented only summary statistics obtained using a federated query design. Progress in this field is significantly impaired by the lack of a large, centralized multi-center, row-level, high-granularity clinical data resource with which to develop and test hypotheses and develop novel predictive and diagnostic computational tools. Therefore, there is an urgent public health need to build such a centralized resource. The Specific Aims for this UL1 Administrative Supplement are: 1. Build a deep and adaptive COVID-19 Clinical Data Mart. We will leverage the CCTSI Informatics Core and our enterprise data warehouse to create a COVID- 19 Data Mart that will include rich clinical data extracted from the electronic health records of large adult and pediatric health systems. We will harmonize the Data Mart to N3C's preferred common data model, the Observational Medical Outcomes Partnership (OMOP) model. 2. Share CCTSI COVID-19 case and control data with N3C. We will secure appropriate regulatory approvals and data transfer agreements and securely transfer harmonized COVID-19 data to N3C. 3. Co-Lead N3C Clinical Scenarios and Analytics. As one of the only practicing ICU physicians in the CTSA Informatics Enterprise Committee, the CCTSI Informatics Core Director, Dr. Tellen Bennett, will play a key role in N3C by engaging other clinician-scientists and leading prioritization and execution of clinical analyses. Taken together, these efforts will accelerate clinical and data science research toward the development of better therapeutic regimens and predictive and diagnostic tools in COVID-19.