Clinical trials rely upon the enrollment of persons representative of the disease or disorder of interest to validate claims of drug or device safety and efficacy in real-world settings. The challenge, particularly in low-resource communities, is reflected in clinical trial data in the varying degrees of clinical monitoring and cultural patterns of health associated with regional healthcare systems or unaffiliated sites otherwise dominated by academic medical centers and high-resource healthcare systems [1]. Overrepresentation by metropolitan centers is largely attributable to the relative decreased engagement of trial sponsors with rural areas, given the higher likelihood of costly external resources required (e.g., external specialists for procedures and adapted supply chain logistics). Rural residents experience longer travel times than those residing in metropolitan areas, which may be prohibitive to necessary enrollment for clinical trials requiring frequent visits [Reference Perni, Moy and Nipp2,Reference Arana-Chicas, Prisco and Sharma3]. Marginalized communities such as American Indian, Alaska Native, and geographically isolated groups have historical hesitancy toward unfamiliar research groups and clinical trials [Reference Mainous, Kelliher and Warne4]. The result of higher operational costs, lower population to enroll, clinical research mistrust, and travel constraints is a general lack of access to clinical trial opportunities, particularly industry-sponsored trials [Reference Unger and Fleury5,Reference Sabesan and Poxton6].
Access to clinical trials is an objective of Rural Healthy People 2030 [Reference Callaghan, Kassabian and Johnson7] given the potential to improve quality of life and decrease morbidity and mortality rates with increased clinical patient monitoring during active trial involvement [Reference McPhee, Nightingale, Harris, Segelov and Ristevski8,Reference Ring and Duska9]. Federal advocacy includes research inclusivity for geographically disadvantaged groups through the Clinical Treatment Act passed in 2020 and the DEPICT Act passed in 2022 [Reference Farris, Crist, Miller and Shannon10–12]. While rural participants are willing to participate in trials when asked by a trusted provider, this population participates at a reduced rate compared to metropolitan and micropolitan counterparts [Reference Arana-Chicas, Prisco and Sharma3,Reference Mainous, Kelliher and Warne4,Reference Sabesan and Poxton6,Reference McPhee, Nightingale, Harris, Segelov and Ristevski8].
Most rural communities remain small in census, and the number of trial participants is smaller still. There is a unique value proposition of this region with higher retention and recruitment rates of American Indian and older adult participants than the national average [Reference Nelson, Johnson, Kiesow, McCrory and Ma13]. As critical access hospitals and regional care facilities feel financial pressure to remain solvent during current funding headwinds, community provider awareness and advocacy of clinical trial inclusion as part of service line availability is a viable option to keep doors open and enhance patient care outcomes [Reference Johnson, Hill, Smith, Marsh and Beer14]. Trial sponsors require access to culturally diverse communities via these local potential research sites with affirmative engagement and responsiveness to the enmeshment of clinical and research in the continuum of patient care [Reference Nelson, Johnson, Kiesow, McCrory and Ma13,Reference Johnson, Hill, Smith, Marsh and Beer14].
Purpose
To better understand the experiences of rural-dwelling patient’s participation in clinical trial opportunities, a collaborative team of nursing and systems engineering researchers from a land grant University in partnership with a large regional healthcare system in the region sought to better understand the personalized the journey and lived experience of a rural trial participant or those interested in participating. These interviews informed a larger project of shared information exchange and clinical research integration in the Electronic Health Record of the healthcare system such that key clinic sites across a wide geographic area were able to communicate key research details, which may inform clinical care or trial opportunities.
Method and sampling
Interviewees were recruited from a purposeful sampling of established active or former clinical trial adult participants from the large healthcare system serving the Intermountain West. A semi-structured interview guide was used with grand and mini-tour questions to facilitate exploration around literature-informed topics, such as the meaning of being a rural-dwelling resident, elements of support during clinical trial participation, the experience of having the opportunity to participate in a clinical trial, and the perception of the clinical trial and the research enterprise. Virtual and in-person interviews were recorded, transcribed, and interpreted from June 2023 to January 2024 using manual coding techniques and thematic analysis [Reference Blair15].
Results
A total of 11 participants completed recorded interviews. The majority of participants (informants) identified as White/Caucasian Non-Hispanic, while 1 informant (9%) identified as American Indian/Alaska Native. The sample was closely distributed between males (4, 36%) and females (7, 64%). The informants identified their chronological age into three categories: 35–50 (2, 18%), 51–65 (2, 18%), and 66+ (7, 64%). Counties where informants reside represent mostly southern Montana, spanning from eastern to western communities. Two informants (18%) are actively involved in a clinical trial, and 8 (73%) had participated in at least one clinical trial in the past, whereas one respondent (9%) has not yet engaged in a clinical trial but was interested in doing so. Trial participation experience included oncology, diabetes, and rare disease programs. Results from participants can be found in Table 1.
Table 1. Thematic Findings of In-Depth Interviews
Discussion
The results from these in-depth interviews present a depiction of rural clinical trial participant experience, motivation, and perceived barriers/facilitators to research engagement that align with other studies surrounding clinical trial equity and opportunity in underrepresented, geographically sparse populations. This work adds new insights into the complexities of rural community culture with engagement of caregivers and support persons, conceptually described as networks or insiders, that are the bedrock of supporting clinically congruent care once in their resident setting. While information surrounding clinical trial opportunities was important, it was the individual who was trusted by the informant that aided in the next steps and determined the overall experience of being on a clinical trial. These findings validate why other programs may not have been successful [Reference Ladd and Wright16]. Familiarity, a rurality concept, can be reflected in a duality where it can inhibit motivation or can be supportive such as with physicians or research nurses as identified in this work who were trusted and seen as operating in the informant’s best interest [Reference Ladd and Wright16].
A novel finding in this work was the perception of being rushed through the research process while grappling with a diagnosis, feeling the need to start activities “right away [P10]” however not hearing about the results of the clinical trial or how the individual participant contributed to the advancement of scientific knowledge related to the drug or device. The respondents’ emphasis on education about clinical research and the immediacy of trial procedures, such as informed consent, reflect the rurality concept of resources, where a rural participant appraises on-hand knowledge or material resource versus those absent but necessary to be successful toward a goal or action [Reference Winters17]. The concept of resources also reflects the knowledge created by the clinical trial as beneficial to not only society at large but also the immediate community. Distance is another concept that encapsulates the behavioral or perceived separation between two or more entities, which was described in this sample not only in the physical sense of travel for trial procedures but the separation of a participant from results and ascribed meaning to their individual journey on the clinical trial [Reference Winters17]. Together, resources and distance demonstrate the dual pressures placed on the participant and the community to learn at an expedient pace about the clinical research enterprise, the individual trial, and then appraise which resources are required to be in place to participate.
There was heightened discussion related to isolation and how this was combated through caregivers, support systems, or when these were notably absent [Reference Winters17]. Professional isolation was experienced by those who continued to be employed during the clinical trial and required more complex planning to support both work and research, such as working “12-hour shifts [P05]” and acknowledging the reduced earnings when a research visit was required if time was taken off work. Compensation provided by the clinical trial was not to an anticipated value beyond travel mileage [P02], with informants describing it hard to “stomach [P07]” the low compensation related to the “time commitment [P09].” More common was the leaning-in of caregivers, family, and spouses to be the additional knowledge repository, advocate, and cheerleader. The community is associated with a relational knowledge that can ameliorate isolation, with many including their healthcare providers and research team in this relational circle of support. There was acknowledgement among informants that shared communication was the bedrock of decreasing isolation and therefore safety and satisfaction in the experience of being a trial participant in a rural setting [P02, P06]. Extrapolation of results may be difficult due to the small sample size and unique nature of the population.
Implications and forward momentum for reflecting rural culture in clinical trials
In alignment with informant reflections related to compensation congruent with participation time and effort, there is current legislative activity to remove taxation from these trial payments. The bipartisan bill, H.R. 7418, the Harley Jacobsen Clinical Trial Participant Income Exemption Act, seeks to reduce the financial burden associated with trial participants and ultimately lessen obstacles for underrepresented individuals to engage with novel treatments [Reference Williams, Fleury and Qasim Hussaini18,Reference McCarthy19]. For some populations, taxation and reporting trial compensation as income can dissuade participation entirely for fear of deportation [Reference McCarthy19]. Inconsistent and confusing language in the informed consent form describes trial payments or compensation as taxable income, lending to the perception that trial participants may be considered as independent contractors to the Internal Revenue Service [Reference Waltz, Davis and Fisher20]. As clinical trials and clinical care blend treatment and disease monitoring strategies, participants may be at risk of misconceptions associated with delineating clinical trial benefits when standard of care diagnostics or assessments may be applicable for research billing. Informants noted in this study that their clinical care visits commonly melded with research visits or procedures, encouraging institutional review of informed consent form language and billing/coding practices that support full transparency in financial elements of value added to participant care and individual responsibilities associated with reporting trial benefits or compensation. The Centers for Medicare and Medicaid Services outlines research-related billing/coding practices as do private insurance companies.
The lived experiences of these informants will contribute to steering research on important elements to include in the information exchange, such as provider notification alerts of potential trial opportunities and specific treatment guidance for acute care providers such as those in the urgent care and emergency care settings. Additional research will include the creation of an online community advisory forum to unite the region in clinical trial opportunity selection and protocol development to ensure alignment of resources, need, and healthcare system capacity to safely conduct clinical trials. This work presents the lived experiences of rural-dwelling adult residents in one region of the United States. As a small sample across a large unaffiliated healthcare system, these findings may not be generalizable to other settings of rurality or those identifying as clinical trial participants. However, the findings in this qualitative study were aligned with quantitative analyses of patterns of trial participant experience and behavior in the region, which facilitated meaning saturation and robust synergistic interpretation [Reference Nelson, Johnson, Kiesow, McCrory and Ma13].
Conclusion
The assimilation of clinical research into the complexity of rural living presents a penultimate challenge for the clinical research enterprise as regulatory pressure mounts to broaden belonging in clinical trial participation to otherwise under-engaged communities. As demonstrated by these interviews in the Intermountain West, representation is a core belief and part of one’s purpose in the value of coming together for the greater good of medicinal progress. The resiliency of rural residents has been reflected in their own words and rings true to guide next steps for trial sponsors to rethink documented barriers and facilitators in a personalized vantage point. While dualities remain, such as telehealth feeling impersonal but the travel challenges to get to the research site, these are largely aspects of known rurality concepts that culturally have co-existed. Through this work, these rurality concepts and lived experiences are intertwined and shed insight on how research teams may interact with new communities and those already willing to contribute to our collective understanding of how innovative medicinal products may improve quality of life on the frontier.
Acknowledgment
The authors wish to express their gratitude to the participants of this study and Billings Clinic Collaborative Science & Innovation team (Manager: Laurie Riemann, Clinical Research Project Manager: Becky Kiesow).
Author contributions
EJ contributed in the protocol design and development, data collection, data analysis, and manuscript writing. DC contributed in the protocol conduct, data collection, data analysis, and manuscript writing. BM contributed in the protocol design and development, data collection, data analysis, and manuscript writing.
Funding source
Genentech Innovation Fund.
Competing Interests
The authors report no declarations of interest.
Ethical statement
This multi-site study was reviewed and approved by the Montana State University Institutional Review Board as Protocol #2023-604-EX.
Open access
