Clinical Research Support Core

临床研究支持核心

基本信息

批准号：
10682166
负责人：
Francis Sessions Cole
金额：
$ 156.84万
依托单位：
HARVARD MEDICAL SCHOOL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-04-19 至 2028-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10682166
关键词：
Acceleration Award Benchmarking Bioinformatics Biological Biological Models Biology Biomedical Research Caring Case Management Clinical Clinical Research Clinical Trials Collaborations Computer Models Consultations Data Data Coordinating Center Data Element Diagnosis Diagnostic Disease Ecosystem Electronic Health Record Ensure Equity Evaluation Expert Opinion Expert Systems Family Funding Genes Genomics Geography Goals Health Promotion Human Resources Immunologics Individual Infrastructure Institution International Manuals Modeling Monitor Pathogenicity Patients Performance Phenotype Process Rare Diseases Reporting Research Research Personnel Research Project Grants Research Proposals Research Support Review Committee Schedule Science Site Standardization Therapeutic Translational Research United States National Institutes of Health Update Work behavioral health cohort data access data management data reduction data sharing design experience experimental study genetic variant insight meetings member metabolomics model organism multiple omics novel operation predictive modeling programs success variant of unknown significance virtual

项目摘要

PROJECT SUMMARY The clinical and biomedical research culture established in the Undiagnosed Diseases Network (UDN) and the Undiagnosed Diseases Program (UDP) led to collaborations within and across institutions that advanced diagnostic success and biological understandings. In order to provide access to this process for a broader number of patients, the individualized translational research process developed in the UDN and UDP must be scaled. The overarching goal of the Clinical Research Support Core of the Data Management Coordinating Center (DMCC) for Diagnostic Centers of Excellence (DCoEs) is to expand this model. This will be accomplished through implementation of computational models that predict likelihood of diagnosis, integration with national and international matchmaking networks, and expanding membership in the undiagnosed and rare disease ecosystem to include previously under- and unrepresented entities. To achieve this goal, the Clinical Research Support Core will focus on the following three specific aims: 1) Establish and manage Case Review Committee meetings and accelerate applicant evaluations, 2) Accelerate diagnostic success by expanding access of DCoE and UDP investigators and clinicians to expert consultants in other matchmaking networks unlimited by geography or institution and by automating and standardizing case status updates, and 3) Provide subawards to DCoEs and/or their collaborators to facilitate on-site coordination, data sharing, and pilot research projects and document progress toward overall DMCC goals.

项目概要未确诊疾病网络 (UDN) 中建立的临床和生物医学研究文化以及未确诊疾病计划 (UDP) 促成了机构内部和机构之间的合作，推动了诊断成功和生物学理解。为了让更广泛的人能够参与这一过程患者数量，在 UDN 和 UDP 中开发的个性化转化研究过程必须缩放。数据管理协调的临床研究支持核心的总体目标卓越诊断中心 (DCoE) 中心 (DMCC) 正在扩展此模式。这将是通过实施预测诊断可能性、整合的计算模型来完成与国家和国际婚介网络建立联系，并扩大未确诊和罕见疾病生态系统包括以前代表性不足和未被代表性的实体。为了实现这一目标，临床研究支持核心将重点关注以下三个具体目标： 1) 建立和管理案例审查委员会会议并加速申请人评估，2) 通过以下方式加速诊断成功扩大 DCoE 和 UDP 研究人员和临床医生在其他牵线搭桥中接触专家顾问的机会网络不受地理位置或机构限制，并通过自动化和标准化案件状态更新，以及 3) 向DCoE和/或其合作者提供子奖励，以促进现场协调、数据共享和试点研究项目并记录实现 DMCC 总体目标的进展情况。