Increasing Participation in Clinical Trials by Those in Rural Areas

Clinical trials investigate the safety and efficacy of medications and devices and are the basis for clinical guidelines and practice changes. Ensuring that clinical trial enrollment effectively reflects representative populations, including those in rural areas, is critical to successfully completing a trial—and leads to higher efficacy of results for all potential patients.

It has been well documented that representation in clinical trials has fallen short for individuals who are Black, Indigenous, People of Color (BIPOC), rural residents, or patients living in disadvantaged areas.[1],[2] This article will specifically address increasing participation in clinical trials by those in rural areas—both patients and health care professionals.

Rural America: Barriers to Care and Participation

Approximately one in five US adults—around 60 million people—live in rural areas.[3] Living and working in rural locations requires traveling long distances for fuel, groceries, faith communities, commerce hubs, education, and health care (primary care, hospitals, and specialists). These distances can deter those interested in participating in clinical trials.

Another issue is the limited time rural residents spend engaging with the healthcare system, which reduces the opportunity to discuss clinical trials. The Community Health Assessment Survey (CHAS)[4] found that about 48% of rural resident respondents had seen a physician in the previous 12 months—about half as often as the national average of 85%[5]

Compounding the barriers of distance and limited healthcare interactions is the issue of limited knowledge about and awareness of clinical Trials. Nearly 88% of rural respondents in the CHAS survey indicated that they knew little or nothing about enrolling in clinical trials.4

Researchers have found that rural residents have identified the following additional barriers to participation in clinical trials:[6],[7]

  • Time and effort to participate
  • Lack of health insurance and potential costs
  • Lack of awareness by medical professionals of clinical trials
  • Lack of convenient or affordable transportation
  • Cognitive barriers
  • Misperceptions about clinical trials
  • Distrust
  • Historical abuses

Connected Clinicians

Addressing each of these barriers requires a multifaceted approach that spans clinical trial ideation through execution. One key factor for success is the presence and involvement of respectful, understanding clinicians committed to acknowledging and addressing historical wrongs and taking the time to listen and answer questions.

Not all clinicians working in rural areas are part of large hospital systems focused on research, yet their engagement as part of the research team can provide a strong connection between the community and the research organization. Engagement can span from sharing information with potential study patients as part of an expanded enrollment strategy to acting as a Primary Investigator or Care Coordinator.

No matter the setting, healthcare professionals who are aware of clinical trial availability are the link to patient education and recruitment. They can share general information about the value of study participation to the individual, family, and greater community, answer questions about clinical research, recommend related educational resources, and act as a conduit that connects patients to potential research opportunities.

When rural-based healthcare professionals contribute to clinical research projects as part of the research team, it broadens the geographic and demographic representation of potential patients, improves the breadth of expertise on the team, may boost the experience of individual healthcare professionals, and expands the ability of healthcare professionals to contribute to their profession. Tapping healthcare professionals from rural areas as researchers may involve additional steps, as there may be a lack of adequate research infrastructure and/or a limited number of committed practicing physicians/healthcare professionals available to staff a large number of studies.[8]

Clinical Trial Study Sites

Utilizing rural healthcare settings as trial sites may also increase representation in clinical trials. Research indicates that many clinical studies take place in areas where population density provides access to a larger study group size, such as in larger cities. In 2022, for example, research analyzed ZIP codes of 2002-2007 study sites and found a limited number of clinical study sites available in rural areas.[9]

To further include healthcare professionals and patients in rural areas in more clinical trials, some researchers utilize a decentralized clinical trial (DCT) model. A DCT may utilize satellite sites as part of the research protocol, e.g., rural hospital or clinic settings where patient visits can be conducted by telehealth and video conferencing [10] or even capitalize on the expertise of local healthcare professionals. Using the DCT model requires a commitment to including satellite sites and related technology and personnel and can reap big rewards in acquiring research data from participants in rural areas.

Tapping Technology

To make it as easy as possible for patients in rural locations to participate in clinical trials, researchers may commit to in-home data collection in addition to, or in lieu of, clinic-based telehealth and videoconferencing at rural healthcare sites. As internet access may be unavailable and/or unreliable in many rural locations, home-based data collection may require a small investment in technology for each home-based subject. Examples include providing Wi-Fi hotspots, ports, and/or computers.

Additionally, technology that can automatically upload information to a research team can ensure ongoing data collection, such as continuous glucose monitors, blood pressure monitors, electrocardiograms, and other devices. Wearable technology can replace the need for patients to keep logs of activity or other health data. Whether information is uploaded automatically or shared from a home or clinic setting, a richer data set can support research objectives.  

Clinical Takeaways

To increase the overall diversity in clinical trials, a concerted and multi-faceted effort will be required, including engaging patients and healthcare professionals from rural areas.

What researchers can do:

  • From the time of the study’s initial inception, identify strategies to address the unique needs of individuals in rural areas
    • Partner with healthcare professionals in rural areas to share possible research opportunities
    • Engage rural healthcare professionals as part of the research team
    • Utilize decentralized clinical trial (DCT) sites
    • Implement home-based technologies as appropriate
    • Consider providing technology such as devices, hotspots, ports, and/or computers for use in data acquisition and sharing

What healthcare professionals in rural settings can do:

  • Learn more about the clinical trials process (such as PCNA’s leadership event on Diversity in Clinical Trials, which will be available soon in our on-demand CE library.)
  • Recognize the patient participants in clinical trials are important to the applicability of study outcomes to all audiences
  • Stay up to date on current study recruitment, such as ClinicalTrials.gov
  • Provide information on clinical trials to patients: ask and answer questions, and provide additional resources (PCNA’s new tool will be available in December 2024)
  • Consider partnering in research as a Primary Investigator or Care Coordinator

What patients can do:

  • Become aware of potential studies that are appropriate, such as ClinicalTrials.gov. Patient organizations focused on particular disease states will often have information on related study possibilities
  • Ask questions about what to expect as a participant in a clinical trial
  • Advocate for yourself if you are interested in, or are a participant in, a clinical trial

References

[1] Caston, N. E., Lalor, F., Wall, J., Sussell, J., Patel, S., Williams, C. P., et al. (2022a). Ineligible, unaware, or uninterested? Associations between underrepresented patient populations and retention in the pathway to cancer clinical trial enrollment. JCO Oncol. Pract. 18 (11), e1854–e1865. doi:10.1200/op.22.00359

[2] Caston, N. E., Williams, C. P., Wan, C., Ye, S., Pywell, C., Ingram, S. A., et al. (2022b). Associations between geography, decision-making style, and interest in cancer clinical trial participation. Cancer 128 (22), 3977–3984. doi:10.1002/cncr.34455

[3] Ratcliffe M, Burd C, Holder C, Fields A. Defining Rural at the U.S. Census Bureau. US Census Bureau, U.S. Department of Commerce. December 2016. PDF. Accessed September 23, 2024.

[4] University of Utah Huntsman Cancer Institute and University of Utah Health. Ladmark Survey Illustrates Cancer Needs for Rural and Frontier Patients. Aug. 8, 2024. Accessed Sept. 30, 2024

[5] Taylor M. Rural patients barriers to care access: 7 notes. Beckers Hospital Review. August 9, 2024. Accessed Sept. 30, 2024.

[6] Tanner A, Kim SH, Friedman DB, Foster C, Bergeron CD. Promoting clinical research to medically underserved communities: current practices and perceptions about clinical trial recruiting strategies. Contemp Clin Trials. 2015. Mar;41:39–44. doi: 10.1016/j.cct.2014.12.010. Epub 2014. Dec 23. PMID: 25542611.

[7][7] Tanner A, Kim SH, Friedman DB, Foster C, Bergeron CD. Barriers to medical research participation as perceived by clinical trial investigators: communicating with rural and african american communities. J Health Commun. 2015;20(1):88–96. doi: 10.1080/10810730.2014.908985. Epub 2014. Sep 10. PMID: 25204763.

[8] Braithwaite JS, Goldstein D, Dowgiallo E, et al. Barriers to Clinical Trial Enrollment: Focus on Underrepresented Populations. Clinical Researcher. 2024;38(2) epub.

[9] Seidler EM, Keshaviah A, Brown C, Wood E, Granick L, Kimball AB. 2014. Geographic Distribution of Clinical Trials May Lead to Inequities in Access. Clinical Investigation 4(4):373–80.

[10] Sedhai YR, Sears M, Vecchiè A, Bonaventura A, Greer J, Spence K, Tackett H, et al. 2021. Clinical Trial Enrollment at a Rural Satellite Hospital during COVID-19 Pandemic. Journal of Clinical and Translational Science 5(1):e136. 77

Related Articles