One of the biggest obstacles to pediatric and rare genetic disease CTR is the small number of participants at any single location, including large medical centers. The Network Capacity Core takes a two-pronged approach to addressing this important issue to advance CTR. The first is collaboration among CTSA hubs on protocols in order to be able to execute them in a timely way and have a large enough sample population to reach meaningful conclusions in the CTR process. LTICs will provide an efficient and effective environment and trial readiness to participate in multicenter studies through the CTSA TICs and streamlined procedures for the implementation of standardized, harmonized multicenter research projects. It will support the startup processes of contracting, budgeting, and working with a centralized IRB process. The LRICs will maximize the recruitment to pediatric and rare genetic diseases studies in the CTSI-CN by using a variety of existing and developing informatics tools, educating users on their use, and reaching out to the community to maximize the buy-in of community stakeholders and their encouragement of their constituents about participation in CTR.
LIAISON TO TRIAL INNOVATION CENTERS
An important objective for all CTSA hubs is the support of collaboration among CTSA hubs towards building a true national CTSA Network as recommended by the Institute of Medicine (IOM) report. In the CTSICN, we consider this objective especially important, as this hub’s focus is on pediatric and rare diseases. Clinical and translational research (CTR) in a single hub, no matter how large and efficient, can only answer a limited set of questions as the sample size in a single hub will always be limited for rare diseases and for most pediatric disease (except, e.g., asthma, diabetes). Only a network of collaborating sites, operating under common and harmonized standards can produce generalizable knowledge to advance the health of children and people with rare diseases. Such a netowrk will be able to ensure both quality and efficiency of research, provided that it has developed at each site an excellent workforce for institutional review board (IRB) approval processes in parallel with budgeting and contracting. CTSI-CN v1.0 has made strides in this direction. In addition to being part of existing networks such as NeuroNEXT, CFAR, PECARN, and COG. Members of the CTSI-CN played leadership roles in the Coordinating Center (CC) for the Cooperative International Neuromuscular Research Group (CINRG). Thus, the CC has essentially served as the CINRG "TIC".
The goal of the LTICs module is to provide an efficient and effective environment and trial readiness to participate in multicenter studies through the CTSA TICs streamlined procedures for the implementation of multicenter research projects. The primary objective of LTICs is to facilitate the initiation and implementation of clinical studies in CTSI-CN, functioning as a liaison between CTR investigators and the planned CTSA TICs. CTSI-CN v1.0 has positioned our hub as an effective catalyst for child-health CTR that spans the translational spectrum.
Aim 1: Improve the efficiency of CTR implementation by supporting investigators in contracting, budgeting and planning for project management – PROCESS STREAMLINING.
Aim 2: Enhance the quality of CTR by providing regulatory support to investigators in establishing/functioning with centralized IRBs (cIRBs) and other regulatory components of the research infrastructure,
such as the Investigational Drug Service (IDS) pharmacy – INVESTIGATOR SUPPORT.
Aim 3: Improve multisite research by defining the processes to work with the to-be-established CTSA Trial Innovation Centers (TICs) for reliance on centralized human subject research approval processes
– CTSI-CN and PARTNERSHIPS.
LIAISON TO RECRUITMENT INNOVATION CENTERS
In the 2013 IOM Report1, research participant recruitment was cited as one of the main impediments for successful CTR. The IOM called for CTSAs to “play a substantial role in facilitating efforts to remediate limitations in the CTR ecosystem”, including addressing the challenges that arise from long research timelines and limited enrollment of research participants in trials that are then abandoned. While recruitment tools are available through the CTSA Network, (e.g. ResearchMatch.org), only 5% of all registered participants in trials are under 18 years of age2. Therefore, for child health-related CTR, there is an unmet need for innovative recruitment and enrollment strategies. Over the last 5 years, the CTSI-CN v1.0 implemented several initiatives to foster recruitment including: 1) using new electronic health record (EHR) tools and data networks to identify research subjects (e.g. i2b2, TriNetX, and Endeca; described in Informatics Core); 2) developing the regulatory framework to use the EHR appropriately in recruitment (Vignette); 3) establishing a patient-friendly, webbased community resource to provide both general and specific information about participating in clinical studies at CNHS and GW; and 4) fostering CTR education and participation through programs focusing on minority and underserved populations in Washington, DC. The LRICs module will build on these previous innovations to achieve the following aims:
Aim 1: Improve recruitment and retention of participants in CTR by developing, deploying, and disseminating novel tools, including Electronic Health Record (EHR) tools for early study feasibility analysis and ongoing
participant enrollment – RECRUITMENT TOOL DEVELOPMENT FOR CHILD HEALTH CTR.
Aim 2: Improve patient recruitment and retention efforts in CTR by establishing synergistic collaborations with community-based organizations, e.g., patient advocacy groups, focusing especially on those working
with minority and underserved populations (in collaboration with the Community Engagement (CE) and Integrating Special Populations (ISP) modules) – ENGAGING COMMUNITIES.
Aim 3: Collaborate with other CTSA hubs and/or Recruitment Innovation Centers (RICs) to enhance recruitment and retention efforts across institutions, with a particular emphasis on child health CTR
– ADVANCE RECRUITMENT FOR CHILD-HEALTH CTR ACROSS THE CTSA NETWORK.
Please visit the Faculty and Staff Directory to find the faculty/staff member(s) responsible for these resources.