A Feasibility Study of the Alliance for Representative Clinical Trials (ARC): Building Clinical Research Capacity in Community-Based Settings

Abstract

Introduction:

Most patients receive care in community settings. However, few community clinicians serve as clinical trial investigators. This limits how many underrepresented patients can take part. The National Minority Quality Forum (NMQF) created the Alliance for Representative Clinical Trials (ARC) to support community clinicians in building research capacity while delivering patient care.

Methods:

NMQF conducted an early-stage feasibility study to understand the conditions required for equitable patient participation in clinical research. This study examined three areas: recruiting community clinicians, completing foundational research training, and assessing site readiness to offer trials. It also explored the social and structural factors that affect readiness and capacity for equitable research participation.

Results:

Ten community clinicians participated in the study, completing training (100%) and site assessments (90%). Eight out of ten (80%) were satisfied with the program and would recommend it. Six out of ten (60%) felt ready to lead a trial. Key barriers included limited staff, infrastructure, and time. Facilitators included trusted recruitment networks and flexible self-paced training.

Discussion:

The ARC showed promise in involving community clinicians in clinical research. These findings highlight the need for broader adoption, including mentorship, infrastructure investment, and financial incentives. They also inform future implementation pathways and align with national efforts to make clinical research more accessible and equitable in community care settings.

Keywords

capacity building clinical trials community clinicians feasibility study health equity infrastructure implementation science representative research participation

Introduction

The National Minority Quality Forum (NMQF) created the Alliance for Representative Clinical Trials (ARC) to bridge the gap between clinical research and daily care. ARC is a community-centered, capacity-building initiative designed to expand equitable access to clinical research by addressing structural, organizational, and relational barriers in settings serving historically underrepresented populations.

Clinical trials continue to underrepresent many populations, creating inequities in who benefits from new treatments.¹ Despite efforts to diversify clinical trial participation, representation remains limited for racial and ethnic minority groups, older adults, people from rural communities, and other historically underrepresented populations.^2–8 Most individuals with chronic conditions receive care in community-based settings, yet trials remain concentrated in academic centers, limiting access and reinforcing inequities.^9–11 Expanding access to clinical trials in community-based settings is therefore an important mechanism for advancing health equity, particularly by improving access to emerging therapies and research participation for populations historically excluded from clinical research.^{1,2,10,12–15}

Although clinician recommendations strongly influence patient participation, many community clinicians remain disconnected from research networks and lack the time, training, or compensation to support research involvement. Evidence affirms that disparities in clinical trial participation stem primarily from structural barriers–including structural racism, language access, geographic distance from research centers, and logistical constraints–rather than patient reluctance.^1,16 When trials are available, patients’ willingness to participate is consistently high across racial and ethnic groups; however, for most people, no trial is available.^16,17 These findings highlight that equitable access—not willingness—is a limiting factor in representative research participation.

Improving diversity in clinical trials requires both policy reform and practical frameworks that decentralize research and embed equity across the trial lifecycle.¹⁸ National reports emphasize offering trials where patients already receive care, supported by sustained investment in community research capacity and coordination.^19,20 These strategies strengthen community partnerships and reduce financial, logistical, and trust barriers.^21,22

NMQF responded to these national calls through ARC, a proof-of-concept initiative designed to translate policy commitments and national initiatives into action (Supplementary Tables S1 and S2). While many initiatives share a vision of diversifying participation, few have tested how to implement this vision in community-based settings. Guided by an Expert Evaluation Board, this early-stage feasibility study examined clinician recruitment, training completion, and site readiness, laying the groundwork for future scaled implementation.

ARC program goals and scope

NMQF has an established history of supporting community clinicians through foundational clinical research training and structured site readiness assessments which examine staffing, infrastructure, technology, governance, and patient population characteristics. To build upon this ongoing work, the ARC program utlizes targeted recruitment and engagement to reach a more underrepresented group of community clinicians. This feasibility phase applied a health equity lens to identify early barriers and facilitators related to clinician engagement, training, and site readiness, with findings informing future implementation design.

The study drew on the Health Equity Implementation Framework (HEIF), which emphasizes three domains: (1) culturally relevant clinician and patient factors, (2) the clinical encounter as a trust-based space, and (3) the broader social context that shapes infrastructure.²³ Applying this framework helped identify key determinants such as structural barriers, relational trust, and the fit between training, clinical sites, and community needs.

Objectives

The study had four objectives: 1.

Recruit and provide training for community clinicians.

Assess clinic-level site readiness and infrastructure.

Engage and convene an Expert Evaluation Board to guide implementation and next steps.

Build a Clinical Investigative Site Network (CISN).

Methods

Eligibility and enrollment

Eligible participants practiced in a community-based clinic, Federally Qualified Health Centers (FQHC), or a private practice, serving ≥30% of racial or ethnic minority patients. They were required to be in good standing with a medical board, have no prior U.S. Food and Drug Administration (FDA) investigator infractions, and commit ≥13 hours to the ARC activities. From September 2022 to May 2024, the NMQF recruited participants through partnerships (e.g., the Association of Black Cardiologists) and direct invitations from the NMQF CRM database.

ARC training overview

As part of ARC participation, clinicians completed foundational clinical research training through the Collaborative Institutional Training Initiative (CITI). Specifically, participants completed the Good Clinical Practice and Human Subjects Research modules, which provide standardized instruction on ethical conduct of research, participant protections, regulatory requirements, and core principles of clinical trial design and oversight. Training was self-paced and completed asynchronously, with a combined estimated time commitment of approximately 6–12 hours, depending on prior experience. All training fees were covered by ARC to reduce financial barriers to participation. Knowledge acquisition and implementation outcomes related to training completion—including acceptability, appropriateness, and feasibility—were assessed using standardized instruments summarized in the Supplementary Materials (Supplementary Tables S3, S4, and S8).

Site assessments

The NMQF ARC investigators conducted in-person site visits that included a structured assessment of patient demographics, clinical and technical infrastructure, staff capacity, and perceived readiness. Readiness domains were operationalized across key areas relevant to community-based trial implementation, including staffing and roles, physical space and equipment, technology and data systems, regulatory and administrative processes, patient population characteristics, and language and accessibility supports (Supplementary Tables S5 and S11).

The assessment combined structured checklists with semi-structured discussions during site visits. Checklists captured the presence or absence of core infrastructure and resources, while guided conversations with clinicians and staff explored workflow, perceived barriers, and contextual factors shaping readiness. Qualitative information from site visits was documented using standardized templates and synthesized through thematic review to identify common patterns and implementation-relevant gaps across sites.

Evaluation strategy

The ARC used a mixed-methods design guided by the HEIF as an interpretive lens to examine how contextual factors can shape clinical research delivery and influence equity in implementation. This approach supported assessment of early-stage implementation outcomes and examination of contextual determinants influencing capacity for equitable research.^23,24 The intervention was the ARC model itself, an implementation strategy designed to operationalize national policy recommendations by strengthening community-based infrastructure. Implementation outcomes (feasibility, acceptability, and appropriateness) were measured using Proctor’s taxonomy.²⁵

Benchmarks were specified as context-specific progression criteria (e.g., ≥80% site completion, ≥90% clinician completion of CITI), consistent with Consolidated Standards of Reporting Trials (CONSORT) feasibility guidance and traffic-light conventions.^26–28 Implementation outcomes were assessed using a brief survey adapted from the Acceptability, Appropriateness, and Feasibility of Intervention Measure (AIM, IAM, and FIM), each rated on a 5-point Likert scale.²⁹ Contextual determinants—including readiness, infrastructure, staffing, and policy environment—were mapped to HEIF domains. Participants completed five assessments (Supplementary Tables S3, S4, S5, S6, and S7), with a total time burden of 7.5–13.7 hours (Supplementary Table S8). Sixty-eight percent completed all assessments; non-completion primarily reflected staffing changes and shifting site priorities.

Results

The results were organized according to the four objectives. Table 1 summarizes the activities, benchmarks, outcomes, and statuses. The detailed descriptive results are presented in Supplementary Tables S9, S10, S11, and S12.

Table 1.

Alliance for Representative Clinical Trials Objectives

Objectives	Activities	Benchmarks (anticipated goals)	Outcomes (achieved goals)	Status
Recruit & train clinicians	Training and onboarding	Ten clinicians	Ten clinicians trained	Achieved
Assess site readiness	Feasibility assessment	≥80% of sites	90% of sites assessed	Achieved
Engage expert evaluation board	Convene expert evaluation board	One board meeting	Two board meetings held	Achieved
Build Clinical Investigative Site Network	Sites onboard trials	≥50% sites	Foundational infrastructure established	Inform adaptations for future implementation

Objective 1: Recruit and train clinicians

The ARC assessed whether community clinicians across diverse roles, practice settings, and geographic contexts could be recruited and complete foundational clinical research training (Supplementary Table S9).

The feasibility cohort included 10 clinicians spanning cardiology, internal medicine, obstetrics/gynecology, pediatrics, geriatrics, and integrated care nursing, with experience ranging from less than 1 year to over 40 years. Participants practiced in private practices, FQHCs, free community clinics, and other community-based settings. The cohort reflected racial and ethnic diversity, with clinicians identifying as Black or African American, Asian, American Indian or Alaska Native, and multiracial/multiethnic and represented urban, suburban, rural, and mixed geographies, highlighting variability in proximity to academic medical centers and access to research infrastructure (Supplementary Table S9).

Patient panels across sites were similarly demographically diverse (Supplementary Table S10). On average, 44% of patients were Black or African American, 19% Hispanic or Latino, and 7% American Indian or Alaska Native; 39% were covered by Medicaid and 18% were uninsured. Panels spanned a wide age range, with 16% under 18 years, 57% aged 18–64 years, and 28% aged 65 years and older. Although detailed language utilization data were not uniformly available, clinicians reported serving patients with diverse language needs, underscoring the importance of culturally and linguistically responsive trial support.

All enrolled clinicians (100%) completed both required CITI courses, meeting the ≥90% training benchmark. Among the six clinicians with paired pre- and post-training assessments, mean knowledge scores increased by an absolute 8.33% (from 85% pre-training to 93.33% post-training).

Implementation outcome ratings were favorable with high ratings for acceptability (87%), appropriateness (100%), and feasibility (87%) (agree/strongly agree) (Fig. 1).

FIG. 1.

Training implementation survey findings. Satisfaction was also high; 71% were satisfied or very satisfied with ARC, and 86% would recommend it to colleagues. However, only 57% reported having sufficient staff and equipment to support trials, and 57% felt confident in serving as principal investigators.

Key learning and future directions

Objective 1 findings indicate that community clinicians can be recruited and complete foundational research training using accessible, self-paced platforms. However, confidence in serving as principal investigators was closely linked to clinic-level readiness. Limitations in staffing, equipment, and operational support constrained clinicians’ perceived ability to lead trials, indicating that training alone is insufficient. Addressing clinic-level infrastructure in parallel with clinician training is essential to translate individual readiness into research participation.

Building on this foundation, the ARC next assessed whether participating clinics had the infrastructure and systems needed to support equitable research implementation.

Objective 2: Assess site readiness

The second ARC objective assessed the readiness of community-based clinics to support clinical trial infrastructure. Nine of the ten participating clinicians (90%) completed the site feasibility assessments, exceeding the 80% benchmark.

Most sites had core research infrastructure, including electronic health records (90%), phlebotomy (70%), multilingual materials (80%), and reported basic emergency preparedness. Fewer sites offered on-site imaging (40%) or advanced equipment. Although six sites reported readiness to conduct trials, most required additional staffing, dedicated space, or system integration to participate fully.

Clinicians cited barriers including limited personnel, constrained space, connectivity challenges, transportation barriers, and variable patient health literacy. They emphasized the need for multilingual, health-literate materials in Spanish, Haitian Creole, Vietnamese, and several African languages (Supplementary Table S11). Despite these constraints, clinicians expressed strong motivation to engage in research aligned with their patients’ needs.

Key learning and future directions

Site assessments demonstrated that while many clinics had foundational infrastructure and strong research interest, readiness to lead trials varied. Readiness depended not only on technical capacity but also on relational factors such as trust, cultural fit, and prior experience. Structural gaps—including staffing, space, transportation, language access, and sustained contact—limit the ability to conduct research without disrupting care.

In-person site visits were critical for clarifying expectations and building rapport, underscoring the value of hands-on support during early implementation. Consistent with the HEIF, findings highlight determinants across individual and structural domains, including communication accessibility and systemic resource inequities.

Building on these findings, the implementation recommendations emphasize pairing infrastructure investment with relational and culturally responsive strategies to support equitable patient participation in clinical research.

Objective 3: Engage expert evaluation board

To guide program design and evaluation, NMQF convened an Expert Evaluation Board of national leaders in health equity, clinical research, and systems transformation. The seven-member board represented diverse disciplines, including public health, pharmacy, epidemiology, cancer equity, and health care innovation. The Board met twice in spring 2024 to review findings, interpret feasibility results, and inform next steps; members also contributed to article development.

The Board recommended four priorities to guide equitable implementation (Supplementary Table S12): 1.

Flexible, community-centered infrastructure.

Mentorship between academic and community sites.

Inclusive clinician and community engagement strategies.

Policy reforms to reduce systemic barriers to clinical trial access.

Key learning and future directions

The Expert Evaluation Board helped situate ARC findings within national equity and implementation priorities. Members emphasized that equitable trial participation requires aligning infrastructure, governance, and mentorship structures with the realities of community practice. Their guidance reframed ARC as both a capacity-building effort and a systems-oriented learning initiative, informing the implementation of recommendations summarized in Table 2.

Table 2.

Recommendations to Guide Future Implementation Efforts

Domain	Key recommendations
Infrastructure and implementation supports	Tailor infrastructure and implementation supports to site-specific needs identified through readiness assessments, including staffing, space, equipment, workflow integration, and associated cost and time requirements. Provide flexible staffing supports (e.g., coordinator time, staffing sub-awards, or shared research support models) to address clinic-level capacity gaps identified during site readiness assessments. Align funding and partnership strategies (e.g., blended public–private funding, sub-awards, sponsor collaboration) to reduce administrative and contracting burdens and sustain community-based research infrastructure.
Capacity building and mentorship	Offer modular, flexible training options with a curated set of eligible courses. Extend training to include support and administrative staff. Pair community clinicians with experienced mentors to build skills, confidence, and applied experience needed to assume principal investigator responsibilities in clinical trials.
Clinician and community engagement	Develop targeted clinician and readiness strategies. Align infrastructure supports with culturally and linguistically responsive engagement strategies, co-designing outreach with community leaders and patient advocates. Ensure availability of multilingual, health-literate materials aligned with the language needs of patient populations served by community clinics. Incorporate transportation supports (e.g., stipends or coordinated services) to address geographic and logistical barriers to trial participation. Support patient navigation and coordination functions to reduce participation barriers related to scheduling, follow-up, and health literacy. Embed community and patient perspectives in ongoing trial-readiness and implementation strategies.
Strategic governance and policy alignment	Engage expert advisors early to refine program goals, timelines, and engagement strategies. Establish participation agreements (e.g., MOUs) that define mutual commitments. Develop metrics for success—such as clinical trial initiation, participant diversity, and sustainability indicators. Engage health-system leaders and payors to align incentives for long-term community participation.

Objective 4: Build clinical investigative site network

The fourth ARC objective focused on conceptualizing a CISN, a national infrastructure intended to support community clinicians in participating in and leading clinical trials. Drawing on findings from clinician training, site readiness assessments, and expert input, ARC explored the core functions and conditions required for such a network.

Due to the short grant timeline, no sites initiated trials during this phase. However, foundational activities generated critical insights regarding governance needs, shared tools, and resource requirements necessary for network feasibility.

Key learning and future directions

This feasibility phase established conceptual and relational groundwork for a community-based clinical trial network. Findings underscored that network formation depends on clear governance structures, standardized processes, and sustained supports to enable participation without disrupting care delivery. Rather than launching a network, this phase clarified the conditions and implementation considerations needed to test such a model in future work, as reflected in the recommendations summarized in Table 2.

Discussion

This feasibility study examined a community-centered, equity-informed approach to expanding community clinician engagement and building capacity for equitable clinical research. Findings demonstrate early feasibility while highlighting persistent structural and relational barriers to sustainability.

Guided by the HEIF, the ARC identified determinants across clinician, patient, and structural domains. Trusting relationships and attention to language and literacy needs emerged as critical readiness factors, while underinvestment in infrastructure and limited staffing remain key constraints.

Together, these findings underscore that equitable patient participation is shaped primarily by system-level conditions rather than individual clinician motivation. Infrastructure, staffing, access, and relational supports play a central role in determining whether community-based research can be implemented without disrupting care delivery.

These findings align with the national evidence demonstrating that system-level conditions—particularly infrastructure, staffing, and access—are central drivers of equity in patient clinical research participation.

Health equity implications

ARC demonstrates that advancing health equity in clinical research requires addressing both social and structural determinants that shape participation.

By applying the HEIF, ARC embedded equity as a core element of study design and evaluation. Findings illustrate how relational factors—such as clinician–patient trust and patients’ language and literacy needs—intersect with broader structural conditions that influence feasibility and sustainability.

Implementation results highlighted persistent barriers, including underinvestment in community infrastructure and limited clinician time and compensation, that disproportionately affect settings serving underrepresented populations. Addressing these barriers requires aligned funding, governance approaches, and policy incentives that support community-based research capacity.

ARC offers a practical implementation-oriented model for translating equity commitments into action. Through trust-based clinician engagement, flexible and culturally responsive training, and context-specific assessment, the approach aligns with national priorities emphasizing community partnerships and tailored capacity building.^9,19,30–32 Together, these findings underscore how equity can be operationalized as a design principle rather than an aspirational outcome in clinical research.

Learning, limitations, and next steps

This feasibility study provides early evidence that the ARC approach—combining site engagement, flexible training, and tailored assessments—can strengthen clinical trial capacity in community settings. While limited in scope and duration, the study offers actionable lessons to inform future implementation efforts aimed to advance equity in clinical research.

Recruitment delays and constrained resources limited the full testing of network-level functions, underscoring the need for longer timelines, stronger infrastructure, and appropriate financial incentives to sustain clinician engagement. Despite these limitations, high training completion and positive implementation ratings demonstrate early feasibility.

Generalizability may vary across clinical contexts. Although participating sites included urban, suburban, and rural settings and several Federally Qualified Health Centers, clinics with fewer resources, practices without FQHC affiliation, and underrepresented specialties may face distinct barriers to trial participation. In such contexts, additional supports—such as expanded staffing models, transportation and connectivity solutions, or specialty-specific training—may be required, reinforcing the importance of adapting implementation strategies to local conditions.

As described in the Methods, this phase examined early-stage implementation outcomes rather than adoption or impact. Future research should evaluate adoption, fidelity, cost, reach, and sustainability to better understand how community-based research infrastructure can be developed and sustained equitably over time.

Recommendations and expansion pathways informed by the ARC feasibility study

Guided by evaluation findings and input from the Expert Evaluation Board, this feasibility phase generated practical recommendations outlining the conditions required to support community-based clinical research. Based upon early findings, these recommendations identify priority considerations related to infrastructure, capacity building, clinician and community engagement, and governance to inform future implementation efforts (Table 2).

This integrated set of recommendations reflects the feasibility study’s central insight: equitable community-based research depends on aligning clinician training with clinic-level infrastructure, relational supports, and governance conditions. By addressing both upstream and downstream determinants, these recommendations emphasize that sustaining equitable research participation requires more than recruitment and training alone.

Together, these findings translate national priorities emphasizing trusted clinician engagement, culturally responsive training, and community-centered capacity building into actionable implementation guidance for future efforts to expand equitable clinical trial participation.

Study Highlights

What Is Already Known on This Topic?

Clinical trial sites are concentrated in academic centers, limiting the participation of underrepresented populations. Few community clinicians have the resources or support to lead research while continuing with patient care.

What Question Did This Study Address?

Can community clinicians feasibly be recruited, trained, and supported to build clinical trial capacity and increase equitable patient participation?

What Does This Study Add to Our Knowledge?

The ARC shows that community clinicians can complete foundational research training and readiness assessments while identifying the structural and relational support needed for success. The ARC highlights key facilitators—trusted recruitment pathways and flexible training—and common barriers, like staffing, infrastructure, and time.

How Might This Advance Equitable Implementation in Clinical Research?

By equipping trusted community clinicians to lead research where patients receive care, ARC provides a practical and scalable model for expanding trial capacity, improving participant diversity, and integrating research into real-world practice.

Authors’ Contributions

Conceptualization was led by S.A., G.P., and M.S.C. Framework development and refinement of research goals were conducted by K.B. Data curation was performed by S.M.E.H., M.S.C., and C.E. Formal analysis was carried out by S.M.E.H., M.S.C., J.M.R., and K.B. Funding acquisition was secured by S.A., C.E., and G.P. Investigation activities were conducted by S.M.E.H., M.S.C., C.E., J.M.R., and K.B. Project administration was supported by S.A., S.M.E.H., M.S.C., and C.E. Methodology was developed by S.A. and M.S.C., with later-stage contributions from J.M.R. and K.B. Supervision was provided by S.A., with additional oversight from S.M.E.H., M.S.C., and J.M.R.; K.B. and M.S.C. also guided methodological refinement and interpretation. Validation was conducted by M.S.C. Visualization was developed by K.B. Writing—original draft was led by J.M.R., K.B., and T.A.B. Writing—review and editing was conducted by all authors, including S.A., J.M.R., K.B., S.M.E.H., M.S.C., T.A.B., N.J.D.D., A.D.M., T.S.M., and C.E.

Editorial Assistance

The authors used AI tools, including ChatGPT and Grammarly, to enhance clarity and consistency during the article editing process. The final content was reviewed and approved by the co-author team.

Ethical Compliance

This project did not involve human subjects research under United States federal regulations (45 CFR 46). The feasibility assessment used non-identifiable organizational and operational data, with no patient-level information collected and no interactions with individuals for research purposes. As such, review or approval by an Institutional Review Board (IRB) was not required. All activities followed ethical principles of equity-centered and community-engaged research.

Footnotes

Acknowledgments

The authors gratefully acknowledge the National Minority Quality Forum (NMQF) for its leadership in conceptualizing and launching the Alliance for Representative Clinical Trials (ARC). NMQF’s commitment to advancing equitable patient participation in clinical research made this feasibility study possible. They extend their sincere appreciation to the clinicians and clinical sites that participated in this early-stage feasibility study. Their willingness to engage in foundational training, site readiness assessments, and collaborative learning provided essential insights into the opportunities and challenges of expanding clinical research capacity in community-based settings. Their contributions, time, and partnership were instrumental in shaping the findings and future directions of ARC.

Author Disclosure Statement

No competing financial interests exist.

Funding Information

This study was supported by the Food and Drug Administration (FDA) Office of Minority Health and Health Equity of the United States Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $496,430, with 100 percent funded by the FDA OMHHE/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the United States government.

Supplemental Material

Abbreviations Used

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