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: 10413256
• 负责人: Barry Coller
• 金额: $ 368.16万
• 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/10413256
• 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.

洛克菲勒大学临床与翻译中心的总体愿景 在CTSA计划的支持下，科学(CCTS)将开发、演示和传播 创新项目，打造以严谨为基础的模范临床研究企业， 负责任和透明的报告，以及科学的诚信，以增强翻译 突破范式的发现，让人类更健康。我们的新计划旨在：1) 确保我们所有的学习都设定了最高标准；2)确保我们的受训人员拥有团队 从事翻译科学工作所需的科学领导技能；以及3)提高 科学严谨性、重复性和报告性。这些新区域建立在 我们开发的基础设施将机械科学整合到社区参与中， 联系基础科学家，加快健康增强产品的开发，并创造 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，以 支持在最高水平的参与者安全的情况下进行临床研究， 科学严谨性、生物伦理和法规遵从性。我们将加强我们的多学科合作 翻译研究导航(TRN)计划和我们与临床主任的合作 社区卫生中心实践研究网络(CDN)，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 报道，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最好的机会改善人类健康。我们将加强 我们强大的项目流水线支持基础和临床研究人员将他们的 通过利用资源，将突破范式的发现转化为新的疗法 三机构治疗发展研究所，罗伯逊治疗发展基金， 以及大学附属的生物技术公司Bridge Medicines。教育全社会 研究人员团队在最高级别的参与者中进行翻译研究 安全、科学严谨、生物伦理和法规遵从性。我们会进一步加强 我们针对KL2临床学者的教育计划强调多学科的团队科学， 临床研究护士、基础科学家和社区临床医生，重点放在我们新的 在耶鲁大学CTSA中心进行团队科学领导力培训 宾夕法尼亚州和哥伦比亚。4.研究和完善临床研究事业，包括 洛克菲勒和全国。我们将继续利用CCTS作为实验室，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，增强严谨性、重复性和报告性，加快评估 通过内部配方提供新的治疗方法，并创建CTSA枢纽的“超级团队”，以 传播我们的社区参与模式，利用基本的机制研究 满足社区确定的卫生需求。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。