Clinical Component

临床部分

• 批准号: 10395947
• 负责人: VALERIE L DURKALSKI
• 金额: $ 9.97万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-15 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10395947
• 关键词: Address; Area; Basic Science; Biomedical Research; Biometry; Clinical; Clinical Research; Clinical Trials; Collaborations; Consultations; Data; Data Coordinating Center; Dedications; Development; Digestive System Disorders; Disease; Education; Ensure; Environment; Fibrosis; Fostering; Funding; Gastrointestinal Diseases; Gastrointestinal Endoscopy; Gastrointestinal tract structure; Goals; Grant; Health Sciences; Inflammation; Infrastructure; Injury; Institution; Lead; Leadership; Liver; Liver diseases; Medical; Multi-Institutional Clinical Trial; Multicenter Studies; National Institute of Diabetes and Digestive and Kidney Diseases; Observational Study; Operations Research; Phase; Positioning Attribute; Public Health; Research; Research Design; Research Personnel; Research Priority; Research Project Grants; Research Proposals; Research Support; Role; South Carolina; Statistical Study; Structure; Therapeutic; Translational Research; Translations; United States National Institutes of Health; Universities; Work; base; clinical center; cohesion; design; effectiveness research; experience; falls; innovation; member; operation; professor; research study; success; translational study

Clinical Component - Abstract The goal of the Medical University of South Carolina (MUSC) Digestive Disease Research Core Center (DDRCC) Clinical Component (CC) is to establish a research support infrastructure of biostatisticians and research operations to promote the effectiveness of research performed by Center members. This will be accomplished by supporting the design, implementation and analysis of research studies in digestive and liver diseases that fall thematically into the DDRCC’s major research priorities. The CC has several unique features, including an extensive track record of prominent, collaborative research in digestive and liver diseases, led by Dr. Valerie Durkalski, Professor of Biostatistics and Director of the Data Coordination Unit (DCU) in the Department of Public Health Sciences at MUSC. Dr. Durkalski and her team are ideally positioned to fill this role based on their experience as the statistical and data coordinating center for many NIH-funded multicenter clinical trials and research studies. Further, CC team members are already heavily involved with Center investigators on a number of NIDDK-funded multicenter studies in gastrointestinal disease. The CC has two Specific Aims: In Aim 1, the CC will collaborate with DDRCC Biomedical Research Cores and DDRCC members to support basic, translational and clinical digestive and liver disease research, and to facilitate the translation of basic research into the clinical setting. The CC members will utilize their expertise in the design and coordination of digestive disease basic, translational and clinical research studies to collaborate with DDRCC members in the planning and execution of proposed research projects. In Aim 2, the CC will provide statistical expertise and support for DDRCC members. The CC will apply their statistical expertise to contribute to the design of innovative and efficient research studies (basic research studies, clinical trials, translational and observational studies), analysis and presentation of pilot data, and the development of grant submissions that will address proposed research questions. The CC will also foster the professional development of New Investigators. In summary, the CC is ideally poised to provide a cohesive platform for facilitating the proposed aims and is well-prepared and committed to ensuring a successful and productive collaboration with the DDRCC Research Cores and members.

临床成分 - 摘要 南卡罗来纳州医科大学（MUSC）消化疾病研究核心中心（DDRCC）的目标 临床成分（CC）是建立生物统计学家和研究的研究支持基础设施 促进中心成员进行的研究有效性的操作。这将完成 通过支持消化和肝病研究研究的设计，实施和分析 从主题上落入DDRCC的主要研究重点。 CC具有多个独特的功能，包括广泛的著作记录 由生物统计学教授兼数据主管Valerie Durkalski博士领导的消化和肝脏疾病 MUSC公共卫生科学系的协调单位（DCU）。 Durkalski博士和她的团队是 理想的位置可以根据他们作为统计和数据协调中心的经验来填补这一角色 许多NIH资助的多中心临床试验和研究。此外，CC团队成员已经很重 与中心研究人员有关胃肠道疾病的许多NIDDK资助的多中心研究。 CC有两个具体的目标：在AIM 1中，CC将与DDRCC生物医学研究核心合作，并 DDRCC成员支持基本，翻译和临床消化和肝病研究，并促进 将基础研究转化为临床环境。 CC成员将在设计中利用他们的专业知识 以及消化疾病基础，翻译和临床研究的协调，以与 DDRCC成员计划和执行拟议的研究项目。在AIM 2中，CC将提供 DDRCC成员的静态专业知识和支持。 CC将运用其统计专业知识来贡献 设计创新和有效研究的设计（基础研究，临床试验，翻译和 观察性研究），试点数据的分析和呈现以及赠款提交的发展 将解决拟议的研究问题。 CC还将促进新调查人员的专业发展。总而言之，CC是理想的中毒 提供一个凝聚力的平台来支持拟议的目标，并准备充分，并致力于确保 与DDRCC研究核心和成员的成功和产品合作。