Core-005

核心005

• 批准号: 10414772
• 负责人: RONALD J. SOKOL
• 金额: $ 210.27万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-05-01 至 2023-11-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10414772
• 关键词: Adolescent; Adopted; Advisory Committees; Age; Awareness; Benchmarking; Budgets; Caring; Child; Childhood; Clinical; Clinical Research; Colorado; Communities; Discipline; Disease; Elderly; Ensure; Ethnic Origin; Evaluation; Fee-for-Service Plans; Gender; Goals; Infant; Information Dissemination; Infrastructure; Institutes; Institution; Institutional Review Boards; Monitor; Participant; Patient Recruitments; Population; Process; Protocols documentation; Race; Research; Research Design; Research Personnel; Research Support; Resources; Review Committee; Safety; Science; Service delivery model; Special Population; Specialist; Standardization; System; Technology; Training; Translational Research; Underrepresented Minority; human subject; improved; minimal risk; patient advocacy group; programs; recruit; research facility; sex; success; underserved community; volunteer

The goal of the Hub Research Capacity program of the CCTSI is to support clinical and translational research (CTR) that engages diverse communities in projects conducted by investigators from a broad spectrum of disciplines across the CCTSI affiliated institutions. As outlined in the FOA, this component includes cores focused on Integrating Special Populations (ISP) and Participant and Clinical Interactions (PCI). The ISP core will build on and expand the extensive existing resources and adopt new strategies to engage volunteers in research, with an overarching goal of ensuring appropriate inclusion by age, sex, gender, race, and ethnicity, and from underserved communities. This will be accomplished through the following Specific Aims: Aim 1: ensure that infants, children, and adolescents continue to be an important focus of CTR within the CCTSI by supporting research on both common and rare childhood diseases. Aim 2: evaluate and promote the appropriate inclusion of older adults in CTR and raise awareness of age bias in research. Aim 3: develop a standardized approach for monitoring recruitment success in CTR protocols and strategies to enhance the inclusion of underrepresented minorities. Examples of the approaches to accomplish these aims include: engaging Patient and Advocacy Groups to assist with study design and patient recruitment; supporting research networks focused on improving care for the most vulnerable elderly; and expanding resources, such as tele-technology, to connect with hard-to-reach populations. The PCI core will focus its efforts on improving infrastructure and processes that enhance the safety, efficiency, and merit of CTR. This will be accomplished through the following specific aims: Aim 4: implement OnCore, a Clinical Research Management System, for all CTR protocols that involve more than minimal risk to human subjects to improve tracking and evaluation of benchmarks of success. Aim 5: develop the PCI Management Program, which will provide oversight of centralized research facilities and staff and expand resources to improve the safety, efficiency, and merit of CTR. Aim 6: ensure the high quality and scientific impact of the CTR portfolio through rigorous review of scientific merit, monitoring of protocol benchmarks of success, and tracking of dissemination of results. Examples of the approaches to accomplish these aims include: centralize the management of protocol documents for coordinated reviews by the Scientific Advisory and Review Committee, Colorado Multiple Institutional Review Board, and other entities; expand the pool of centrally-trained and –managed research personnel under a fee-for-service model, including research coordinators, budget specialists, and regulatory specialists; and utilize OnCore to monitor protocol-specific benchmarks of success in participant accrual and retention, compliance to the protocol, and safety. The Hub Research Capacity component of the CCTSI is fully committed to building infrastructure and developing and streamlining processes that will enhance the reach and impact of CTR.

CCTSI中心研究能力计划的目标是支持临床和转化研究 (CTR)让不同的社区参与由来自广泛领域的调查人员进行的项目， 跨CCTSI附属机构的学科。如FOA所述，该组件包括核心 重点是整合特殊人群（ISP）和参与者与临床互动（PCI）。的ISP 核心方案将利用和扩大广泛的现有资源，并采取新的战略来吸引志愿人员 在研究方面，总体目标是确保按年龄、性别、种族和族裔适当包容， 以及服务不足的社区。这将通过以下具体目标来实现：目标1： 确保婴儿、儿童和青少年继续成为CCTSI内CTR的重点， 支持对常见和罕见儿童疾病的研究。目标2：评价和促进适当的 将老年人纳入CTR，并提高对研究中年龄偏见的认识。目标3：制定标准化的 在CTR协议和战略中监测招募成功的方法，以增强纳入 代表性不足的少数民族。实现这些目标的方法包括： 和倡导小组协助研究设计和患者招募;支持研究网络， 改善对最脆弱老年人的照顾;扩大资源，如远程技术， 难以接触的人群。PCI核心将致力于改善基础设施和流程， 提高CTR的安全性、效率和优点。这将通过以下具体目标来实现： 目标4：实施OnCore，一个临床研究管理系统，用于所有涉及更多内容的CTR协议。 比对人类受试者的最小风险更好地跟踪和评估成功的基准。目标5： 制定PCI管理计划，该计划将提供对集中研究设施和人员的监督 并扩大资源，以提高CTR的安全性、效率和优点。目标6：确保高质量和 通过严格审查科学价值、监测方案， 成功基准以及跟踪结果的传播。实现的方法示例 这些目标包括：集中管理方案文件，以便科学委员会协调审查 咨询和审查委员会、科罗拉多多机构审查委员会和其他实体;扩大 在收费服务模式下集中培训和管理的研究人员库，包括研究 协调员、预算专家和监管专家;并利用OnCore监控方案特定的 参与者累积和保留、方案依从性和安全性方面的成功基准。轮毂 CCTSI的研究能力部分完全致力于建设基础设施和发展， 简化进程，以扩大合作减少风险的范围和影响。