The Clinical and Translational Science Institute at Children’s National (CTSI-CN) serves as a dual-institutional “home for child health clinical and translational research (CTR)” in the Washington, DC metro area. The Administrative Core is integrated across Children’s National Hospital and George Washington University (GW). The Core provides:
- A shared vision and trans-disciplinary framework to support inter-institutional collaboration and stakeholder engagement.
- Coordination and facilitation of resource sharing.
- Streamlining of regulatory and other research-related processes.
- A competitive funding program to promote new, innovative CTR through pilot and voucher awards.
- Timely, strategic communications about CTR opportunities to a broad, multi-institutional membership and community partners.
- A structure for minimizing barriers for multi-institutional CTR.
In the past, the Administrative Core focused on providing a stable, streamlined administrative structure that emphasized child-health CTR, on promoting team science, and on minimizing administrative barriers. While
still providing those functions, the Administrative Core has pivoted toward an outward-collaborative position that more effectively emphasizes enhanced interactions with a broad community of stakeholders (local and national), including other hubs in the CTSA Network, as well as active engagement with NCATS initiatives (e.g., the Trial Innovation Centers, the Recruitment Innovation Centers, and the Domain Task Forces). The overarching objective is to share our expertise in processes, methodologies, and implementation strategies that promote and accelerate high quality child-health CTR. In turn, we will integrate into our hub the vetted, high-value initiatives from other hubs within the CTSA Network that similarly advance child health CTR.
The organizational and governance structure of the Administrative Core is designed to address the following aims:
AIM 1: Provide a flexible, streamlined administrative structure that embraces diverse stakeholders, minimizes barriers, facilitates communications, and effectively leads change to support multi-institutional CTR.
AIM 2: Leverage partnerships within the CTSA Network to share our expertise in processes that promote and accelerate high quality child-health CTR and integrate vetted, high-value processes developed by other
hubs within the CTSA Network.
AIM 3: Implement continuous and systematic monitoring of milestones and evaluate the impact of the CTSI on advancing child-health CTR benchmarks
– EVALUATION & CONTINUOUS IMPROVEMENT.
AIM 4: Improve the system-wide review and workflow processes to enhance continuous quality improvement and create a sustainable framework for quality and efficiency across the CTSI-CN
– QUALITY & EFFICIENCY.
Evaluation & Continuous Improvement
In CTSI-CN v2.0, the Evaluation and Continuous Improvement (Evaluation) module will advise the CTSI-CN leadership to ensure that high quality CTR is performed locally at the hub, regionally through collaboration with geographically co-located CTSA hubs, and nationally through a virtual network of CTSA partners. To improve support for this function, we plan to implement standardized and innovative procedures that evaluate progress toward meeting the CTSI-CN aims, as well as the impact of CTR performed at our hub.
In the past, the Evaluation module provided the linkage between promise and delivery through a process of periodic and summary assessments of progress in the CTSI-CN as a whole and each of its components. Much more than an impartial grader, the Evaluation Team has played an important role in identifying issues in need of attention and served as a source of advice and assistance to address the challenges that emerged.
The Evaluation team will work with the CTSI-CN Leadership Team, the EAC, and CTSA partners to:
AIM 1: Ensure that CTSI-CN v2.0 objectives are progressing by implementing continuous and systematic monitoring of milestones and by providing consultation and coordination to help address challenges that arise
– MILESTONE MONITORING AND SUPPORT.
AIM 2: Evaluate the impact of the CTSI-CN on advancing CTR benchmarks by documenting progress in outcomes that assess transformational team science gains in educational, scientific, clinical and community
benefits and the health of children, families, and communities – BENCHMARK AND CTR IMPACT MONITORING.
AIM 3: Track data and monitor the progress of the CTSI-CN infrastructure and leadership to efficiently and effectively meet the aims of the hub, providing independent periodic reports to the CTSI-CN internal Advisory
Board and the EAC – EXTERNAL ADVISORY COMMITTEE.
AIM 4: Contribute to CTSA Network-wide enhancement of CTR evaluation through partnerships with other CTSA hubs to collaboratively develop and implement a set of common metrics across the CTSA hubs
– EVALUATION STANDARDS DEVELOPMENT.
Quality & Efficiency
Improving the impact of Clinical and Translational Research (CTR) requires a streamlined, efficient research infrastructure. Efficient research processes are ever more needed given the limited funding available to fully cover costs of clinical trials and research translation. Developing innovative processes to achieve the highest standards of safety, quality, compliance, and efficiency are paramount for successful translation of discoveries into interventions (drug, devices, diagnostics, and behavioral therapies)6-8 that can improve the health and quality of life for children, including those with a rare disease, their families, and their communities.
The Quality & Efficiency module will enhance our research protocol review processes to ensure that studies have a sound design, are feasible, and have sufficiently detailed implementation plans to be of high quality. Further, we will identify studies at risk of failure and intervene with support, or assist with early closure. We will address streamlining study workflow processes through the application of LEAN rapid improvement strategies (methods commonly applied to health care processes to identify and reduce system inefficiencies and improve user satisfaction) to CTR. Finally, we will increase dissemination of research findings through several platforms aimed at making information accessible to community stakeholders.
The Quality & Efficiency module is designed to address the following aims:
AIM 1: Expand the review of protocols on design, feasibility and quality of implementation aspects and provide individualized support to the investigators – INVESTIGATOR SUPPORT.
AIM 2: Improve the system-wide research study workflow for protocols from protocol development to study completion – INFRASTRUCTURE INTEGRATION and PROCESS STREAMLINING.
AIM 3: Increase dissemination of research findings to the community through diverse methods to impact health policy and public health – COMMUNITY ENGAGEMENT.
Please visit the Faculty and Staff Directory to find the faculty/staff member(s) responsible for these resources.