Developing, Demonstrating, and Disseminating Innovative Programs to Achieve Translational Success

开发、展示和传播创新项目以实现转化成功

• 批准号: 10349629
• 负责人: Barry Coller
• 金额: $ 367.1万
• 依托单位: ROCKEFELLER UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-05 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10349629
• 关键词: Address; Affect; Area; Bioethics; Biotechnology; Certification; Cessation of life; Clinical; Clinical Investigator; Clinical Nursing Research; Clinical Research; Clinical Sciences; Collaborations; Communities; Competence; Complex; Consultations; DNA sequencing; Data; Development; Diagnosis; Disease; Education; Elderly; Elements; Enrollment; Ensure; Environment; Evaluation; Formulation; Funding; Genome; Grant; Health; Health Policy; Hospitals; Human; Human Resources; Immunocompetence; Individual; Informed Consent; Infrastructure; Institutes; Institution; Knowledge; Laboratories; Leadership; Medical; Medicine; Methods; Modeling; Modification; Monitor; NCI Scholars Program; Neighborhood Health Center; New York; Nurses; Nursing Research; Outcome; Participant; Patients; Pennsylvania; Pharmacy facility; Phase; Policies; Population; Prevention; Public Health; Publications; Reporting; Reproducibility; Research; Research Design; Research Personnel; Resources; Science; Scientist; Special Population; Speed; Surveys; Time; Training; Translational Research; Translations; Universities; Vision; base; career; clinical center; clinical investigation; community engagement; design; experience; high standard; human disease; improved; innovation; monoclonal antibody production; multidisciplinary; next generation; novel; novel therapeutics; outreach; participant enrollment; participant safety; pharmacokinetics and pharmacodynamics; practice-based research network; programs; recruit; skills; success; therapeutic development; translational scientist

The overall vision of the Rockefeller University Center for Clinical and Translational Science (CCTS), supported by the CTSA program, is to develop, demonstrate, and disseminate innovative programs so as to create a model clinical research enterprise built on rigor, responsible and transparent reporting, and scientific integrity to empower translation of paradigm-breaking discoveries into better human health. Our new initiatives are designed to: 1) ensure that all of our studies set the highest standards; 2) ensure that our trainees have the team science leadership skills needed for a career in translational science; and 3) enhance scientific rigor, reproducibility, and reporting. These new areas build on the infrastructure we have developed to integrate mechanistic science into community engagement, reach out to basic scientists, speed the development of health- enhancing products, and create an optimal training environment. Our specific aims are: 1. To provide a robust infrastructure to support the conduct of clinical investigation at the highest levels of participant safety, scientific rigor, bioethics, and regulatory compliance. We will enhance our multidisciplinary Translational Research Navigation (TRN) Program and our collaboration with Clinical Directors Network (CDN), a Practice Based Research Network of Community Health Centers, to ensure that our studies meet the highest standards of design, feasibility, method validity, and transparent reporting, supporting our active participation in the CTSA Trial Innovation Network. 2. To ensure that every discovery at Rockefeller has the best chance of improving human health. We will enhance our robust pipeline of programs to support basic and clinical investigators move their paradigm-breaking discoveries into new therapeutics by leveraging the resources of the Tri-Institutional Therapeutic Development Institute, the Robertson Therapeutic Development Fund, and the University affiliated biotechnology company, Bridge Medicines .3. To educate the entire research workforce team in conducting translational research at the highest levels of participant safety, scientific rigor, bioethics, and regulatory compliance. We will further enhance the multidisciplinary team science emphasis of our educational programs for KL2 Clinical Scholars, Clinical Research Nurses, basic scientists, and community clinicians, with a focus on our new Team Science Leadership training with the CTSA Hubs at Yale, University of Pennsylvania, and Columbia. 4. To study and improve the clinical research enterprise both at Rockefeller and nationally. We will continue to use the CCTS as a laboratory for investigating the clinical research enterprise itself and methods to improve it, including obtaining outcome data from research participants, enhancing rigor, reproducibility and reporting, speeding the evaluation of novel therapeutics via in-house formulation, and creating 'super teams' of CTSA Hubs to disseminate our model of community engagement harnessing basic mechanistic studies to address community-identified health needs. We will disseminate the results throughout the CTSA consortium and scientific community by publications, presentations, and active participation in CLIC and CD2H initiatives.

洛克菲勒大学临床和转化中心的总体愿景 科学 (CCTS) 在 CTSA 计划的支持下，旨在开发、展示和传播 创新方案，打造严谨的临床研究典范企业， 负责任和透明的报告以及科学的诚信可以增强翻译的能力 突破范式的发现可以改善人类健康。我们的新举措旨在：1) 确保我们所有的研究都设定最高标准； 2）确保我们的学员有团队 转化科学职业所需的科学领导技能； 3) 增强 科学严谨、可重复性和报告。这些新领域建立在 我们开发了将机械科学融入社区参与的基础设施， 接触基础科学家，加快开发增强健康的产品，并创建一个 最佳的训练环境。我们的具体目标是： 1. 提供强大的基础设施 支持在参与者安全的最高水平上进行临床研究， 科学严谨性、生物伦理学和法规遵从性。我们将加强我们的多学科 转化研究导航 (TRN) 计划以及我们与临床总监的合作 网络（CDN），一个基于实践的社区卫生中心研究网络，以确保我们的 研究符合设计、可行性、方法有效性和透明度的最高标准 报告，支持我们积极参与 CTSA 试验创新网络。 2. 确保 洛克菲勒的每一项发现都有改善人类健康的最佳机会。我们将加强 我们强大的计划管道支持基础和临床研究人员移动他们的 通过利用资源，突破范式地发现新疗法 三机构治疗发展研究所、罗伯逊治疗发展基金、 和大学附属生物技术公司 Bridge Medicines .3。为了教育全体 研究人员团队以最高水平的参与者进行转化研究 安全性、科学严谨性、生物伦理学和法规遵从性。我们将进一步加强 KL2 临床学者教育计划的多学科团队科学重点， 临床研究护士、基础科学家和社区临床医生，重点关注我们的新研究 耶鲁大学 CTSA 中心的团队科学领导力培训 宾夕法尼亚州和哥伦比亚州。 4、研究和完善临床研究事业 洛克菲勒和全国。我们将继续使用CCTS作为实验室来调查 临床研究企业本身及其改进方法，包括获取结果数据 来自研究参与者的意见，提高严谨性、可重复性和报告，加快评估速度 通过内部配方开发新疗法，并创建 CTSA 中心“超级团队” 利用基本机制研究传播我们的社区参与模型 满足社区确定的健康需求。我们将在整个 CTSA 中传播结果 联盟和科学界通过出版物、演讲和积极参与 CLIC 和 CD2H 倡议。