September 14, 2023
- May 09, 2022 - Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional). See NOFO PAR-22-167.
National Center for Advancing Translational Sciences (NCATS)
National Human Genome Research Institute (NHGRI)
The purpose of this Notice of Special Interest (NOSI) is to expand the list of current CTSA Program research priority areas described in PAR-22-167.
This NOSI invites applications to design, develop, demonstrate, implement, and evaluate innovative tools and resources that will (1) transform, increase, and improve the recruitment of participants in clinical trials and (2) improve the use of participant-based information that will inform safety and efficacy for improving participants recruitment in clinical trials.
Award recipients are expected to work collaboratively with members of the Clinical and Translational Science Award (CTSA) Program and the Trial Innovation Network (TIN), while also engaging the broader CTSA community, to achieve individual and consortium goals and objectives. Successful applicants, funded via this NOSI, will become members of the TIN, have members that are part of the TIN Network Executive Committee (NEC), and adhere to its governance model.
Background
In July 2016, NCATS established the TIN, which is composed of the Trial Innovation Centers (TICs) and the Recruitment Innovation Center (RIC). The TICs were established to provide resources to enhance efficiency, improve trial start-up, speed recruitment, and harmonize processes across the CTSA Program for multi-site clinical studies. The RIC was established to develop innovative solutions and demonstrate how these can be successfully applied to accelerate research participant recruitment and, over time, establish best practices that can be generalized to a broad range of research studies across the CTSA Program. The TIN NEC develops and implements the TIN's operational and scientific strategic goals and provides regular updates to the CTSA Program, NCATS staff, and various external groups. The TIN has established processes for interactions between CTSA investigators via Hub Liaison Teams that function as an interface between the CTSA hubs and the national collaborative activities of the CTSA Program.
The TIN maintains an electronic toolbox of clinical trial resources and disseminates best practices and methods for conducting clinical trials through collaboration webinars.
Research Objectives
NCATS is also interested in tools and resources to advance decentralized methods to support rural and remote settings, and expand the recruitment of minorities, women, and members from rural-based communities in clinical trials. The intent of the NOSI is to expand the TIN program both scientifically and geographically to provide more diverse collaborative opportunities for innovation across the CTSA consortium. Applications must be scientifically sound and use the latest evidence-based recommendations and guidelines to address the critical barriers that hinder increasing the number of participant recruitment in clinical trials. Tools and resources that are innovative, effective, scientifically based, and transformational may be digital, non-digital, or both. These may include, but are not limited to:
- methods to improve disease progression modeling to advance the use of participant-based information that will inform safety and efficacy,
- tools and resources that advance the digitalization of clinical trials activities,
- innovative ways to incorporate clinical and demographic characteristics of intended populations in the absence of self-identification,
- improving rural inclusion in centralized and decentralized clinical trials,
- user-friendly dynamic model on the inclusion/exclusion criteria and its impact on participant recruitment in clinical trials.
NCATS understands the importance of having robust, engaging, and meaningful ethical approaches in clinical trials and translational research. Therefore, applicants are required to describe, in their applications, ethical approaches that are integrated and evaluated throughout their program. In addition, applicants may propose studies using either single or mixed methods for, but not limited to, qualitative and quantitative approaches, economic and normative analysis, and ethical underpinnings of beliefs, practices, and policies within their proposed program.
When developing research plans, applicants should describe how their project will stimulate complementary and synergistic collaborations to build on the strength and resources of the CTSA Program to increase participant recruitment in large-scale NIH trial networks. Applicants must also describe in their applications:
- complementary and synergistic efforts that each collaborator will contribute to both phases of the project,
- plans and timeframe for multiple collaborators participating in this research,
- milestones, metrics, individual responsibilities, timelines, and plans for dissemination, implementation, and evaluation in their milestone and sustainability plans.
Applications should include plans in their research strategy that describe how proposed tools and resources will be disseminated to the CTSA Program consortium. Proposed tools and resources are encouraged to also be scalable to serve the needs of the clinical trial community. In addition, proposed tools and resources should be applicable to a clinically and socio-demographically diverse array of participants, customizable as needed, participant-centered, and address barriers that limit participant recruitment into clinical trials.
NCATS also encourages the submission of applications that explore the utilization of artificial intelligence (AI) and other digital-based technologies to increase and improve participant recruitment in clinical trials. Applicants are encouraged to include in their proposals the use of AI-based algorithms, natural language processing, predictive analytics, and digital platforms. Examples may include, but not limited to, innovative tools and resources that improve eConsent, electronic outcome assessments, onsite and remote data capture and analysis, and leveraging heterogenous datasets and technologies for improving the identification and retention of participants in clinical trials.
Applicants should describe in their applications how approaches will mitigate harmful bias and other factors and ensure objectivity to promote meaningful, equitable, trustworthiness, and beneficial inclusion in clinical trials. Preference will be given to applications that propose tools and resources that are not similar and/or duplicative of resources currently provided by the TIN and/or CTSA programs.
National Human Genome Research Institute (NHGRI)
NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.
For this NOSI, NHGRI intends to support the development of tools and resources that foster the use of genomics in clinical trials. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:
- Division of Genome Sciences: https://www.genome.gov/about-nhgri/Division-of-Genome-Sciences
- Division of Genomic Medicine: https://www.genome.gov/about-nhgri/Division-of-Genomic-Medicine
- Ethical, Legal, and Social Implications Research Program: https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program-ethical-legal-social-implications
- Office of Genomic Data Science: https://www.genome.gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science
- Training, Diversity and Health Equity Office: https://www.genome.gov/about-nhgri/Office-of-the-Director/Training-Diversity-and-Health-Equity-Office
Applications for clinical trial tools and resources relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.
Application and Submission Information
This notice applies to due dates on or after October 17, 2023 and subsequent receipt dates through October 18, 2024.
Submit applications for this initiative using one of the following notice of funding opportunity (NOFO) or any reissues of this announcement through the expiration date of this notice.
- PAR-22-167: Limited Competition: Clinical and Translational Science Award (CTSA) Program: Collaborative and Innovative Acceleration Award (UG3/UH3 Clinical Trial Optional)
All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:
- For funding consideration, applicants must include “NOT-TR-23-026” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Although NHGRI is not listed as a Participating Organization in all the NOFOs listed above, applications for this initiative will be accepted.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Please direct all inquiries to the Scientific/Research, Peer Review, and Financial/Grants Management contacts in Section VII of the listed notice of funding opportunity.
Please direct all inquiries related to this Notice of Special Interest to:
Ken Wiley, Jr., Ph.D.
National Center for Advancing Translational Sciences
Telephone: 301-402-8188
Email: [email protected]
and Human Services (HHS)
