Why Diversity Of Geography Matters: A Call To Drive Rural Patient Enrollment
By Louis Johnson, principal, Aries Clinical Consulting
Strategies for improving clinical trial diversity have focused on the recruitment of research participants based on race and ethnicity, specifically, the minority, marginalized, or disenfranchised populations. However, those efforts should also address differences in geography.
Nearly 60 million people in the United States — or about 20% of the population — live in rural areas (U.S. Census Bureau, 2017). For those seeking medical care, that means traveling more than two times as far as those who live in urban areas (Lam, Broderick and Toor, 2018). The Pew Research Center (2018) noted that people who live in rural areas are about 10.5 miles from the nearest hospital, compared to 5.6 miles for suburban residents and 4.4 miles for people living in cities. This study also revealed that a quarter of rural Americans with the longest travel times reside more than 30 minutes from their nearest acute care facility.
While this data illustrates a geographical disadvantage for rural patients seeking clinical care, the same is likely true for their access to clinical research. Interestingly, a 2021 study found that 731 of 2,313 study patients, or about 32%, in 292 clinical trials lived in rural areas (Baharucha, 2021). The data suggests, then, that rural patients are having to leave their communities and travel farther to enroll in clinical trials. Baharucha also stated, “Indeed, the 174,503 clinical trial sites in the U.S. FDA Bioresearch Monitoring System between 2002 and 2007 were highly clustered around urban areas with healthcare and/or social service facilities.”
How This Happens, And Why It’s A Problem
Clinical trials are typically conducted at clinical sites in urban areas where there is generally better healthcare compared to rural or regional facilities. The urban environment also provides patients with more access to specialized care centers and more physicians to choose from. In addition, some rural facilities do not have adequate equipment for study conduct or adequate couriers and access to dry ice to ship laboratory samples. As a result, rural patients generally have to travel to urban facilities to participate in clinical trials.
Some clinical trials have adapted by encouraging patients who live outside of the areas to travel to the clinical location. Patient concierge services collaborate with CROs to coordinate patient travel to the clinical sites. This often involves securing flights, hotels, and other travel considerations and accommodations.
However, if studies are not designed to accommodate patients from rural locations, a rather large segment of our population will continue to be burdened by trial participation or excluded altogether. This is not unlike neglecting the inclusion of marginalized races or ethnicities. Ethically, this may be perceived as being intentionally exclusionary or dismissive to those marginalized groups and further contribute to poor health literacy (Ladd and Wright, 2023). Scientifically, these populations are being excluded from the trials and valuable information and data may unfortunately be excluded from clinical trials.
What Can Be Done?
The COVID-19 pandemic certainly opened the door for alternative study design, with changes such as the increased use of home health nurses, telemedicine, and patient concierge services to assist with arranging travel and lodging for participants. Some sponsors are permitting home health nurses to perform some laboratory specimen draws in the participants’ homes. These developments are making study participation more accommodating for all types of patients Sponsors and CROs may want to continue that change in mindset by further modifying study design and execution. This may well begin with investigator and site selection. As sites are selected, there should be better or greater importance placed on ensuring that a greater cross-section of the population can be included in clinical trials.
Intentional Rural Site Selection And Education
This would entail recruiting and training physicians and clinical staff in rural environments as well as being intentional with diversifying the rural and urban study populations. Research naive sites would require quite a bit of physician training to become investigators. This would require physicians to learn how to complete case report forms and update medical records ensuring that the subject health information is blinded, and they would be required to attend periodic meetings associated with the clinical trials. The staff at the site would need to be trained on how to manage study recruitment, data entry, and prepare data and materials for clinical monitoring.
Allowing Telemedicine
The addition of telemedicine also will bridge the gap between rural patients and urban clinical sites. Telemedicine allows rural patients to take devices home or use their own devices to communicate remotely with clinical teams. The entire world acclimated to various types of remote communication and device usage during the pandemic, and that growth should be harnessed not left to languish. Adequate training at the clinical site will assist with technology limitations for inexperienced and possibly elderly patients.
Offering Home Visits
For those patients who are not mobile or require assistance, home nursing visits would be a great addition to the study conduct. Adding home nursing vendors as an option at the beginning of study start-up would allow more potential study subjects.
Expanding Transportation Budgets
Sponsors and CROs may consider increasing transportation accommodations in the study budgets. This may also include incorporating concierge services. As noted previously, concierge services can coordinate travel and hotels. If long-distance travel is not required, sponsors and CROs may also include local transportation services such as car services or public transportation. For example, in densely populated areas such as New York, Chicago, and San Francisco, public transportation is regularly used by many residents. However, for study participation, transportation costs may need to be made a reimbursable cost in the study budget.
Clinical studies always have been an option when a patient is no longer responding to the viable standard-of-care treatment. Clinical trial recruitment may be enhanced by considering the contrast between recruitment at urban study locations versus rural study locations. Increasing access to studies using targeted investigative selection, the employment of telemedicine, the use of home nurses, and incorporating transportation into study budgets will bridge the gap between those locations and enable a lot of studies to recruit a better cross-section of the population.
Going Beyond Race And Ethnicity With Diversity
Diversity is always seen as an issue associated with race or ethnicity. However, geography may be just as important because the distance from research centers and other medical facilities marginalizes these communities. To make clinical trials more inclusive, stakeholders at CROs and sponsor organizations must intentionally expand to different communities to recruit different patients. This may mean literally looking at a map and identifying underrepresented communities. Expanding research into new geographical areas opens up the possibilities for increased health awareness and contributions to diversifying the healthcare system.
About The Author:
Louis Johnson is a medical research professional with over 25 years of experience in the pharmaceutical industry. His first three years were in pharma sales with the remaining years in clinical research. His expertise lies in clinical trial management and operations with a special focus on diversity in clinical trials and healthcare equality. Louis is also skilled in the areas of process improvement, strategy, and planning. Louis has Bachelor of Arts and Master of Science degrees in biology from Hampton University and Doctor of Health Administration (ABD) from A.T. Still University. In his spare time, he is a fitness enthusiast and is a volunteer football coach. He lives in the western suburbs of Chicago.