Key Dates

Related Announcements

PAR-22-122, Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional)

NOT-TR-22-021, Notice of Special Interest: Trial Innovation Center (TIC) Topic Area for Limited Competition: Clinical and Translational Science Award (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional)

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

The purpose of this Notice is to inform applicants of one of the topic areas for the June 21, 2022 due date of the NCATS CTSA Program funding opportunity announcement (FOA) PAR-22-122, Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional).

Background

Through this notice, NCATS will support applications for Clinical and Translational Science Award (CTSA) Program consortium-wide resource centers that will rapidly demonstrate and disseminate innovative resources (to include capabilities) that have demonstrated impact at a local or national level to the wider consortium. Applicants must address the topic areas described below.

In July 2016, NCATS established the Trial Innovation Network (TIN) with three Trial Innovation Centers (TICs) and one Recruitment Innovation Center (RIC). The TICs were established to transform the CTSA network’s ability to implement multi-site studies by adding innovative network capacity to the existing strengths at the CTSA Hubs. The RIC was focused on implementing successful, evidence-based recruitment and retention strategies to improve both the quality of clinical trials and the value of research to all Americans. The RIC works in partnership with researchers/study teams to provide tailored support and advice to enhance recruitment and retention for individual studies. The RIC, in collaboration with Hub liaison teams (HLT) at each CTSA Hub, provides access to millions of possible participants for research studies, resources and expertise within the CTSA network for NIH- and federally supported clinical studies as well as clinical trials conducted by the private and non-profit sectors.

The TIN has established processes for interactions between CTSA investigators and TIN liaison teams, consultations on clinical trial proposals, recruitment and retention strategies, single IRB coordination and review, and site identification and assessment. In addition, the TIN maintains an electronic toolbox of clinical trial resources and disseminates best practices/methods for conducting clinical trials and clinical research studies through Collaboration Webinars.

The goal of this Notice of Special Interest (NOSI) is to solicit applications for the June 21, 2022 receipt date of the NCATS CTSA Program funding opportunity announcement (FOA) PAR-22-122, Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional). NCATS seeks to fund the activity to identify innovative, effective and efficient approaches to research participant recruitment and retention across the CTSA network and to serve as a national model for effective recruitment and retention in clinical trials. The RICs are expected to demonstrate and disseminate innovative solutions that can be successfully applied to accelerate research participant recruitment and retention. The RICs are expected to work in partnership with each other, the TICs, and individual CTSA hubs to improve the implementation of multi-site studies across the CTSA network.

Research Objectives

The primary objective of the RICs is to provide evidence-based strategies to enhance participant recruitment and retention in clinical trials and studies, including addressing ways to enhance diversity, equity and inclusion of all populations enrolled in the study. Strategies should begin during the planning phase of the study and extend beyond the implementation phase to consider dissemination and communication of trial results to participants and accelerate the successful completion of multi-site trials including the diversity of those enrolled. The lack of participant diversity in many clinical trials and studies—despite increasing diversity in the US—jeopardizes the generalizability of study findings, increases the risk of perpetuating and exacerbating health disparities and decreases the quality of health care for all. Overcoming this translational science challenge is crucial to reducing disparities and advancing health equity. Barriers to clinical trial participant diversity, such as medical mistrust; trial availability, access, eligibility, and enrollment practices; and negative beliefs, norms, and attitudes, present substantial challenges—and yet, they are modifiable (Gray, Darrell II, Diversity in Clinical Trials; An opportunity and imperative for Community Engagement Lancet 2021, Vol. 6. Issue 8, p605-607.)

The focus of this initiative is to improve recruitment into trials and build trust with communities not currently participating in clinical research. Note that there may be observational studies that could benefit from innovations in recruitment and retention so that the term “multi-site trial” in this NOSI is used in a broad sense for interventional and observational research studies. Single-site studies are not the focus of the TIN. However, it is anticipated that the new tools and approaches created will be generalizable to widely benefit trials, and ultimately clinical practice.

Specifically, an individual RIC should have the staffing and expertise to:

• Develop comprehensive, study-specific recruitment and retention plans, including feasibility assessments.
• Develop strategies focused on ensuring equitable recruitment, retention and inclusion of racial/ethnic minority populations and NIH-designated populations that experience health disparities.
• Monitor race/ethnicity/age/gender screening and enrollment information for trials.
• Develop recruitment and retention plans that have attention to adequate gender, race, and ethnicity inclusion to assure that an NIH valid analysis for Phase III trials may be conducted if appropriate.
• Develop innovative approaches to recruitment and retention for different research settings.
• Assist with innovative approaches to engage communities for individual trials.
• Develop centralized recruitment and retention materials for study teams in appropriate languages that are easily adaptable across study sites.
• Develop innovative tools, and methods to recruit research participants such as social media that have the potential for broad dissemination to help investigators recruit and retain participants.
• Use electronic cohort identification and characterization methods to identify sites for individual studies as needed.
• Develop methodology for characterization of cohorts that are standardized and allow for harmonization of clinical data for advancing translational science leveraging existing data science principles like FAIR and TRUST.
• Engage with FDA to support regulatory science for innovative methods that support participant facing approaches for recruitment and retention.

Trial Innovation Network Coordination

NCATS will be responsible for organizing and providing overall support and coordination of consortium-wide activities, by means of cooperative agreements, for the TIN and the CTSA network. In addition to regular grant stewardship by a program officer, a NCATS Project Scientist will be involved with the TICs/RICs as a NCATS partner, consistent with the Cooperative Agreement mechanism.

A Network Executive Committee (NEC) consisting of representatives from the individual TICs/RICs and NCATS will be established to coordinate consortium-wide TIN activities. Specifically, the TIN NEC will develop and implement the operational and scientific strategic goals of the TIN, provide regular updates to the CTSA program, collaboratively engage non-CTSA stakeholders, and ensure excellence and harmonization of consortium-wide TIN activities. NCATS will appoint External Scientific Consultants to provide the TIN NEC with feedback on the overall effectiveness, impact and value of TIN activities and resources to the CTSA consortium, NCATS/NIH stakeholders and the clinical trial operations community.

NCATS will make final decisions regarding TIN consortium-wide activities, allocation of studies to TICs/RICs, and use of NCATS TIC/RIC funding to support resources provided to individual investigators and protocols.

Other committees will be established as needed to oversee daily operations of the TIN and TICs/RICs and to deliver approved resources such as Single IRB educational resources and standard agreement templates.

Specific Aims: Briefly state the specific aims of the center indicating how it will demonstrate and disseminate highly innovative, collaborative and impactful translational science resources (to include capabilities) that will address the goals of the CTSA Program and can accelerate the recruitment and retention of all populations in multi-site studies. Specific Aims should reflect that the RIC will provide recruitment and retention support that will vary with different projects depending on the complexity and stages of trial work, as well as depending on the needs and contributions of the clinical investigators at individual CTSAs.

Research Strategy: Applications should include the following information in the subsections detailed in the SF424 (R&R) Application Guide and PAR-22-122. Any unique capabilities/experiences the proposed RIC may have in supporting certain types of trials/interventions/sites or working with vulnerable or underrepresented populations, should be indicated in the Research Strategy section.

Describe the relevant collaborative expertise and record of the proposed RIC in supporting investigators who seek assistance with cohort assessments, recruitment and retention resources or other resources proposed in the application.

Innovation: Describe any novel or innovative approaches the proposed RIC plans to utilize to support recruitment and retention of diverse populations for multi-site trials. Applicants should describe how they will develop and test innovative “outside of the box” recruitment strategies and how they will work with potential research participants and other relevant stakeholder communities, such as clinicians, patients, or community organizations, as applicable, to develop novel recruitment materials or media.

Applicants are encouraged to describe any special group expertise or unique strengths such as tools or approaches the proposed RIC may offer to the collaborative effort (e.g., experience in collaborations with NIH ICs, community partners, or patient groups). This could include best practices for engaging all participants, including those from under-represented minorities, those over the age of 65 years or pediatric populations, through social media, tools and methods to adequately consent participants remotely, or other ways to enhance the efficiency of clinical trials.

Approach: Describe how the proposed RIC will provide the following resources to individual CTSA investigators submitting proposals for TIN consultation:

• Electronic Cohort Assessments: This resource will provide consolidated de-identified, aggregate data to investigators that is derived from the electronic health record (EHR) at individual sites. It should include a process that leverages Hub liaison teams’ (HLT) recruitment and retention efforts at CTSA Hubs that can be rapidly mobilized to respond to public health needs.
• Recruitment Planning and Feasibility Assessments: A resource that includes strategies to identify and engage specific population(s), including how to communicate and engage potential participants and meet realistic enrollment and retention goals, and an evaluation of the study proposal to identify barriers to recruitment and retention.
• Expression of Interest: Describe a plan to work with the other TIC(s) and RIC(s) to develop a formal outreach from the TIN to CTSA sites announcing a possible trial opportunity. This process is intended to provide CTSA sites, their affiliates, and partners, with opportunities to participate in potential trials through a TIN-developed outreach model and to create a virtual network in which any CTSA may act as the data coordinating center for a trial. The proposed Expression of Interest process may include requests for sites to determine feasibility of study protocol and/or site budget, to conduct an EHR-based Cohort Assessment to assess available recruitment populations, and/or to identify a local site investigator. The Expression of Interest plan in the application should include details on how Hub Liaison Teams (HLTs) will be involved in the Expression of Interest process and how non-CTSA clinical centers may be added to trials to augment participant recruitment. Principles of diversity, equity and inclusion should be applied to all processes described in the Expression of Interest plan. The Expression of Interest process should include approaches for ensuring geographic diversity of recruitment sites such as engagement with other NIH clinical trial networks, PCORnet, and/or IDeA Centers for Translational Research.
• Recruitment and Retention Materials and Tools: This resource should include materials and tools to enhance diversity, equity and inclusion in clinical trials, tools to promote bi-directional engagement of participants with researchers, and multi-lingual recruitment tools to enhance recruitment of all eligible populations.
• Community Engagement Resources: This resource will engage relevant stakeholders in the recruitment process to foster trust and promote community engagement. It should include methods to address the barriers to participation in clinical trials e.g. medical mistrust, trial availability, access, eligibility and enrollment practices, negative beliefs, norms, and attitudes and resources to help investigators return results to study participants.
• Skills development: The RIC should describe plans to disseminate skills enhancement opportunities for investigators and clinical research personnel at various career stages/experience levels at CTSA Program Hubs that would be developed in collaboration with NCATS and the other TICs/RICs. Enhancing skillsets across the entire lifecycle of a trial from raising awareness, to study design, to approaches to engagement and enhancing recruitment of under-represented groups in clinical trials is encouraged. Skills enhancement opportunities may include dissemination of common methods for standardizing the characterization of cohorts based on FAIR and TRUST data science principles. Skills enhancement opportunities may be piloted and further developed/refined in collaboration with NCATS and the other TICs/RICs.

Additional Research Strategy Elements Required for the Parent Funding Opportunity Announcement, PAR-22-122

Program Director/Principal Investigator: Without duplicating information in the biosketches, describe how the PD/PI and other designated senior/key personnel have demonstrated expertise in the proposed resource and/or the capability to assist with participant engagement and provide recruitment and retention resources.

Addressing a systemic barrier in clinical and translational science: Describe how the resources demonstrated and disseminated by the proposed RIC will address CTSA Program Strategic Goals. Describe a vision for how the proposed RIC in collaboration with the other TICs/RICs will address CTSA Program Strategic Goals.

NOTE that the proposed Recruitment Innovation Center is expected to address CTSA Program Strategic Goals 1, 2, 3, 4 and 5:

1. Advance clinical and translational science: develop, demonstrate and disseminate scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination.
2. Promote partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally and nationally.
3. Create, provide, and disseminate innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all.
4. Create and implement scientific and operational innovations that increase the quality, safety, efficiency, effectiveness and informativeness of clinical research.
5. Provide a national resource for the rapid response to urgent public health needs.

Needs Assessment: Provide a needs assessment that includes a review of the landscape and gaps of existing resources (including research capabilities) across the CTSA consortium. This must include an analysis of the existing utilization and adoption. Provide a rationale why the resource has the likelihood to be impactful for the CTSA consortium. Provide a description of how, once demonstrated and disseminated the resource and/or capability has a high likelihood of having a sustained impact on translational science.

Evidence that the proposed resource is ready for use and dissemination: Provide a strategy for determining that a proposed resource and/or capability has been tested/validated and led to a measurable impact at one or more hubs in an area of translational science that addresses one or more of the CTSA Program Strategic Goals.

Strategy for generating evidence for resources that are not evidence-based:

If applicable, for innovations that have preliminary evidence for advancing clinical research/clinical trials, provide a plan to validate those resources as part of the implementation plan. This could include testing methods to rapidly identify and enroll participants for clinical trials, methods to reach and enroll diverse and underserved populations in clinical research, and best methods to include the patient’s perspective in a clinical research study. If the resources will be used to implement clinical trials, provide a plan to evaluate if the resources enhanced the implementation of the resultant trials, such as improving diversity of the study population or accelerating recruitment.

Dissemination Plan: In the Dissemination Plan section of the Research Strategy, describe plans for the proposed RIC in collaboration with other TICs/RICs, to establish a process to develop an electronic portal for managing requests for TIN consultations and resources. The TIN consultation process should be designed to help CTSA investigators develop proposals into protocols, enhance study operations, and/or improve recruitment and retention. The Dissemination Plan for consultations in the application should include development and maintenance of TIN SOPs, an IT system to manage proposal submissions, and specific details of interactions with the CTSA Hub liaison teams (HLT) to ensure prompt submissions and responses to requests for TIC/RIC resources including plans for managing conflicts of interest.

Plans for disseminating any of the proposed RIC resources including tools or approaches the proposed RIC may offer (e.g., tools to enhance recruitment and retention or best practices for feasibility assessments) should be described.

Describe how any unique experiences the proposed RIC may have in providing skills development opportunities to develop the multi-site clinical and translational research workforce will be disseminated. The vision for collaborating with other TICs/RICs to disseminate TIN resources to the CTSA consortium should be described in this section of the application.

Evaluation Plan: In the Evaluation Plan section of the Research Strategy, applicants must provide a method to monitor the success of recruitment and retention efforts, including diversifying clinical trials. Applicants must also provide an estimate of the proposed RIC’s capacity to provide resources for multi-site clinical studies in the next funding period and detail the milestones and metrics that will be used to monitor progress and access performance of those resources.

The vision for an overall Evaluation Plan of how the TICs/RICs will collaborate to disseminate the specified TIN resources related to recruitment and retention to the CTSA consortium should be described in this section of the application.

Management Plan: In the Management Plan section of the Research Strategy, describe how tasks will be delegated within the RIC and how teams within the RIC will communicate with the TICs.

Describe a plan to collaborate with the other TICs/RICs and the CTSA Program hubs when specific TIN resources are disseminated to the CTSA consortium. Describe plans for integration of the proposed RIC into the coordination plan for the Trial Innovation Network and the vision for how the proposed RIC will contribute to the TIN Network Executive Committee (NEC).

Sustainability Plan: In the Sustainability Plan section of the Research Strategy, describe how the proposed RIC may be able to increase capacity should more sponsors and investigators than planned for express interest in working with the RIC and how the proposed RIC will maintain its capacity to function as a recruitment and retention center after NIH funding ends. Describe how the proposed RIC will continue to disseminate recruitment innovations and provide skills enhancement opportunities after NIH funding ends.

Applicants may describe a plan for how the proposed RIC in collaboration with the other TICs/RICs can maintain and disseminate TIN resources with broad applicability after NIH funding ends.

External Scientific Consultants: Applicants should describe plans for the appointment of External Scientific Consultants including a Community Advisory Board to provide advice and feedback to the proposed RIC about its strengths and weaknesses as a recruitment center, the potential value and utility of any operational innovations that the proposed RIC is refining or adapting for dissemination as a TIN resource, the potential value and utility of any skills enhancement opportunities that the proposed RIC is piloting, and the efficiency and effectiveness of the proposed RIC in demonstrating and disseminating TIN resources. NOTE that NCATS will appoint External Scientific Consultants to provide advice to the TIN NEC on the overall effectiveness, impact and value of the combined TIC/RIC activities and resources from the network level to the CTSA consortium, NCATS/NIH stakeholders and the clinical research community.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Application and Submission Information

This notice applies to application receipt dates on June 21, 2022.

Submit applications for this initiative using the following funding opportunity announcement (FOA).

• PAR-22-122, Limited Competition: Clinical and Translational Science Awards (CTSA) Consortium-Wide Centers: Resources for Rapid Demonstration and Dissemination (U24 Clinical Trials Optional)

• For funding consideration, applicants must include “NOT-TR-22-020” (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.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

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