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Biomedical Research Core 3 - Clinical Research Core

生物医学研究核心 3 - 临床研究核心

基本信息

批准号：
10686076
负责人：
Alan S Yu
金额：
$ 26.65万
依托单位：
UNIVERSITY OF KANSAS MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-15 至 2025-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10686076
关键词：
Address Advocacy Age Autosomal Dominant Polycystic Kidney Belief Biological Markers Biomedical Research Blood specimen Caregivers Clinical Research Clinical Trials Clinical Trials Network Collection Common Data Element Communities Computer software Consensus Data Collection Data Sources Databases Development Disease Disease Progression Disease model Enrollment Environment Family Family member Functional disorder Goals Health Personnel Healthcare Individual Industry Infrastructure International Kansas Longitudinal cohort Maps Natural History Outcome Outcome Measure Patient-Focused Outcomes Patients Pharmacotherapy Phenotype Prognostic Marker Protocols documentation Race Registries Research Research Personnel Research Priority Resources Risk Site Source Standardization Terminology Translating Translations Update Urine Work biomarker discovery clinical development cohort compare effectiveness data format data harmonization data integration data modeling data standards design diverse data empowerment exosome experience information gathering instrument multiple data sources novel novel therapeutics patient engagement patient oriented preference programs recruit shared decision making socioeconomics tolvaptan tool translational pipeline trial design trial readiness urinary

项目摘要

Clinical Research Core - Project Summary/Abstract The overarching challenge in PKD is how to translate the many advances in basic scientific understanding of the pathophysiology of PKD into the development of effective new drugs. Specific challenges include a shrinking pool of patients available for clinical trials, lack of biomarkers in early disease, lack of widely- available, standardized data models to harmonize diverse data sources, and limited engagement of patients and their families in prioritizing research questions. The goal of the Clinical Research Core is to facilitate research across the translational spectrum from T1 to T4 by PKD investigators nationwide. This will be achieved through the development of multiple tools and resources that will be made freely available to the research community. The specific aims are: 1) to create a consortium of academic centers across the Central and Western regions to form an ADPKD clinical trial network; 2) to expand and continue to follow a longitudinal cohort of young patients with early ADPKD and control subjects and collect biospecimens for biomarker discovery; 3) create a standardized data collection instrument for PKD studies in RedCAP and software for automated mapping into a standard data format required for registration studies; and 4) use our patient engagement resource to identify patients' priorities for research questions and use this to inform research strategy and directions in the PKD community.

临床研究核心-项目摘要/摘要