Boston University Clinical and Translational Science Institute - U Program

描述(由申请人提供)：波士顿大学临床与转化科学研究所(BU CTSI)由波士顿大学医学院(申请人)、波士顿大学查尔斯河校区、波士顿医学中心及其15个社区卫生中心和罗杰·威廉姆斯医学中心(位于罗德岛州普罗维登斯)组成，并与波士顿VAMC和伊迪丝·诺尔斯·罗杰斯纪念退伍军人医院建立了合作伙伴关系。该研究所的愿景集中在提供资源和服务的过程改进、改变游戏规则的颠覆性创新和基于能力的团队科学教育。三个高度互动的研究所旨在帮助创建最高效的临床和翻译研究系统，开发创造性的科学工具来加快和重组传统研究过程，并培训未来的翻译科学家来做这件事。我们将：1)创建翻译科学的综合之家 这包括：A.整合了一项针对药物和设备开发空白的试点奖励计划；B.拥有高度安全的符合HIPAA标准的NIST批准的数据环境；C.包含人类受试者研究的效率衡量标准；D.采用新的评估工具，评估流程和成本，以应对新的机会和战略。2)创建高效的临床和转化研究服务交付，以实施简化和提高临床研究的质量、安全性、效率和成本的解决方案。这包括：a.熟练的研究人员；b.基于电子病历的种族人口登记；c.更快的监管审批；d.研究设计、生物统计学和生物信息学的咨询服务；e.从我们的登记处采集血液，用于从正常受试者中建立诱导性多能干细胞，用于药物毒性筛查；以及f.加快和重组传统研究的创造性工具。3)为未来科学家创建职业发展计划：A.具有基于能力的课程和评估方法；B.支持基于KL2导师的翻译科学计划；C.启动新的TL1计划，以支持专注于再生医学的翻译科学博士学者；D.提供导师技能培养工具，以维持高质量的研究指导；E.创建在线自我指导的模块化课程，以增强信息学和其他关键翻译研究主题的知识；F.实施教育评估计划；G.帮助科学家完成研究的下游商业化阶段。这些协会和目标将支持NCATS改变和加快临床和转化性研究的规划和实施的使命。

DESCRIPTION (provided by applicant): The Boston University Clinical and Translational Science Institute (BU CTSI) is comprised of the BU Medical Campus (applicant), BU Charles River Campus, Boston Medical Center with its 15 Community Health Centers and Roger Williams Medical Center, in Providence, Rhode Island, along with partnerships with the Boston VAMC and Edith Norse Rogers Memorial Veterans Hospital. The Institute's vision centers on process improvement in providing resources and services, on game-changing disruptive innovations and on competency based team science education. Three highly interactive institute aims help create the most efficient system for clinical and translational research, develop creative scientific tools to expedite and retool traditional research processes, and train future translational scientists to do it. We will: 1) Create an Integrated Home for translational science that: A. integrates a pilot award program to target gaps in drug and device development; B. has a highly secure HIPAA compliant NIST-approved environment for data; C. contains efficiency measures for human subjects research; and D. incorporates new evaluation tools that assess processes and costs to be responsive to new opportunities and strategies. 2) Create an efficient delivery of Clinical and Translational Research Services to implement solutions that streamline and improve the quality, safety, efficiency and cost of clinical research. These include: A. skilld research personnel; B. an EMR-based Registry of ethnic populations; C. faster regulatory approval; D. consultative services for study design, biostatistics and bioinformatics; E. biobanking blood from our Registry for creation of iPS cells from normal subjects for drug toxicity screening; and F. creative tools to expedite and retool traditional research. 3) Create a Career Development Program for Future Scientists that: A. has a competency-based curriculum and evaluation approaches; B. supports a KL2 mentor based program in translational science; C. launches a new TL1 Program for supporting PhD scholars in translational science focused on regenerative medicine; D. provides mentor skill building tools to sustain high quality research mentoring; E. creates online self-directed modularized courses to enhance knowledge in informatics and other key translational research topics; F. implements an education evaluation plan and G. helps scientists with the downstream phase of commercialization of research. These associations and aims will support the mission of NCATS to change and speed the planning and implementation of clinical and translational research.