Development of a multi-omic clinical decision platform to guide personalized therapy

接种新冠肺炎大大降低了与严重急性呼吸综合征冠状病毒2型感染和严重疾病相关的发病率和死亡率。然而，疫苗的效力以及免疫反应的持久性和稳健性仍然存在许多问题，特别是在免疫受损的人中。SeroNet有几个机构专注于使用基于EMR的现实世界方法和/或建立具有纵向评估的新的前瞻性队列，在免疫受损人群中进行流行病学研究。当合并在一起时，有大量的癌症患者，包括血液系统恶性肿瘤、实体癌和造血细胞移植。队列组是累积的，并前瞻性地跟踪各种免疫疗法/癌症治疗的感兴趣的终点和影响。此外，还有大量的自身免疫性疾病患者、艾滋病毒携带者和SOTR患者。我们建议利用现有的基础设施来建立SeroNet‘Pooling Project’。我们的总体方法将是建立一个论坛，以协调同步努力，在多个SeroNet站点汇集关于免疫受损人群的个人水平数据。我们的提案将利用现有的SeroNet Epi Ops和Data Ops工作组基础设施来制定行动计划，以协调、同步和跨参与站点传输数据，并促进对个人级别数据的荟萃分析，以回答免疫受损人群中的关键研究问题。我们计划使用一种模型来促进对特定免疫受损人群的并行数据协调和分析，在这种模型中，不同的地点被分配来领导或共同领导不同的研究问题。最后，我们计划通过科学出版物、遵守数据共享政策和更广泛地在社区一级传播SeroNet的调查结果来传播成果。

COVID-19 vaccination substantially reduced morbidity and mortality associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and severe illness. However, many questions remain about the efficacy of vaccines and the durability and robustness of immune responses, especially in immunocompromised persons. SeroNet has several institutions focused on conducting epidemiologic studies in immunocompromised populations using either EMR-based real-world approaches and/or building novel prospective cohorts with longitudinal assessments. When combined, there are substantive populations of patients with cancer, including hematological malignancies, solid cancers, and hematopoietic cell transplants. The cohort groups are accrued and followed prospectively for endpoints of interest and impacts of various immunotherapies/cancer treatments. In addition, there are large number of patients with autoimmune diseases, patients living with HIV and SOTR. We propose to leverage the existing infrastructure to establish the SeroNet ‘Pooling Project.’ Our general approach will be to establish a forum to coordinate a synchronized effort to pool individual-level data on immuno-compromised populations across multiple SeroNet sites. Our proposal will leverage the existing SeroNet Epi Ops and Data Ops Working Groups infrastructure to formulate a plan of action to harmonize, synchronize and transfer data across participating sites and facilitate meta-analyses of individual-level data to answer critical research questions in immunocompromised populations. We plan to facilitate parallel data harmonization and analyses on specific immunocompromised populations using a model where different sites are assigned to lead or co-leading different research questions. Lastly, we plan to disseminate results through scientific publications, adherence to data sharing policies and wider community-level communications of SeroNet findings.