Clinical Research in Rural America: An Efficient Vehicle to Deliver Medical Care

  • February 16, 2023
  • By Dr. Jim Cremins, MD

Rural America has limitations accessing quality healthcare. With access barriers, lower health literacy levels and higher rates of poverty, rural residents are at a disadvantage in receiving the healthcare they deserve.

Approximately 15% of our country’s population, equating to almost 46 million people, classify as rural residents. This population is often older with higher rates of substance abuse, mental health conditions, greater burden of chronic disease and shorter life expectancy. Additionally, rural residents are the highest population with heart disease, cerebrovascular disease, chronic lower respiratory disease, and lung cancer.

While rural residents are more likely to have multiple health conditions, compared to those living in urban settings, the delivery of healthcare to rural areas remains a significant challenge.

The Healthcare Disparity in Rural America

 

It is no secret that rural residents encounter barriers to healthcare that limit their ability to find accessible and quality care. This includes the lack of healthcare facilities and providers nearby, the financial means to pay for transportation to services, and a lower prevalence of health insurance to facilitate access to medical care.

While access barriers to vital healthcare services is the most common disparity in rural America, there are other health and lifestyle issues that are plaguing rural residents, including:

  • Poorer air quality and water quality
  • Higher rates of tobacco use, hypertension, and obesity
  • Less likely to wear a seatbelt
  • Limited grocery options, and lower availability of healthy foods
  • Lower “health literacy”, and an incomplete perception of being healthy
  • Higher rates of poverty in a rural setting

Improving Access to Clinical Trials in Rural Populations

 

Historically, the healthcare industry has segmented clinical trials in larger urban areas near an established university medical center. This environment provides a large number of patients, and access to multiple specialists and investigators. However, as the industry has evolved, there has been a realization that there are many trials with fewer patients to meet enrollment needs.

Coupled with a documented shortage of clinical investigators, there has been an immediate need for new strategies and options to expand access to clinical trials. Stakeholders are now shifting focus and embracing rural markets, bringing the clinical trial to the patient where they live, work, and receive their routine care.

Increasing Diversity in Clinical Trials

 

In 2019, the United States FDA issued a guidance calling for greater diversity in clinical trial populations, with the purpose of developing a full picture of the risk or benefit of an investigational product. One of the main reasons for this push was the difference in which diverse groups responded to medical treatments. Such differences can be incorporated into product labelling, thereby enabling doctors to make the best decisions regarding treatment.

The most predominate population of clinical trial participants are Caucasian individuals in urban and suburban locations. Within this context, diversity would mean more than just racial factors. A diverse clinical trial population would include different ages, ethnic groups, genders and geographic settings. Rural America would provide for more diversity in trials and would benefit from the attention of a research team focused on providing additional care during a trial. Unfortunately to date, rural populations are historically underrepresented in trials.

To meet FDA expectations of diverse enrollments, it is necessary for sponsors and research organizations to extend their reach to new territories. Studies must be brought to rural areas through collaborating with healthcare services that interact with patients in remote settings.

How Integrated Research Organizations are Brining Clinical Research to Rural Communities

 

To increase rural population participation in clinical trials, several provisions must be considered. This includes seamless and efficient implementation, in addition to a logical expansion of potential trial sites. Easy access is imperative for potential participants.

Integrated research organizations, such as ObjectiveHealth, are focusing on this challenge by joint venturing with rural health systems to provide an integrated, turnkey research solution to serve these communities that offer research as a true care option. Patients benefit by having access to new and innovative therapies at no cost, advanced diagnostics, and more care provided by their provider and research team.

Rural health research and finding solutions to overcome access barriers is imperative. Companies like ObjectiveHealth are solving these complex healthcare issues and are spearheading quality care delivery that will improve the health status of rural residents.