Unlocking the Power of Representation in Clinical Trials

Updated on September 29, 2023

In 2020, the FDA reported that three-quarters of clinical trial participants identified as white in a group of 32,000. Only 11% identified as Hispanic, along with 6% and 8% Asian and Black, respectively. These numbers can be attributed to the lack of outreach conducted, as well as a distrust among these communities for the American healthcare system.

Historically, clinical trials have lacked data for minority ethnic populations, an issue that impacts everyone. A lack of diversity in clinical trials equates to a lack of nuanced understanding of the tested treatments. The lack of diversity is not only limited to those who are a part of the historically underrepresented racial and ethnic groups, but also individuals with disabilities, older adults, and LGBTQIA+ communities. This is often due to a lack of access to healthcare, language barriers, mistrust of the medical system, and other socio-economic factors.

In recent years, there has been a growing focus on increasing diversity in clinical trials to ensure that new treatments are safe and effective for all individuals. In 2022, the FDA issued guidance to encourage the industry to embrace steps to improve diverse enrollment and retention of clinical trial participation.

A recent survey found that out of nearly 800 respondents, 84% of CRO and sponsor representatives indicated having a goal to increase diversity of underrepresented individuals. However, only 62% reported having an action plan in place to meet the recommendations of the FDA.  

While the industry is working to include underrepresented populations in trials, there is still work to be done, especially in eliminating the barriers to accessing clinical trials and managing the logistics that are involved with participating in a clinical trial.

Accessibility and Logistics

Underrepresented groups face many challenges, which restrain them from participating in research studies. In rural and underdeveloped communities, there is often a lack of awareness and outreach carried out for clinical trials. This leads to large populations of minorities being left out of research, simply because they aren’t aware of the trials.

There is a need for the industry to make improvements toward reaching these underrepresented communities. For example, hosting events and connecting with these individuals face-to-face. This shows effort put forth by the medical industry, helping to build trust, while also creating awareness and knowledge about clinical trials.

The most critical barrier for these individuals is accessibility. There are many logistical components involved in participating in a clinical trial. Individuals that rely solely on their own income can’t take time off work to make multiple on-site visits or do not have the transportation to do so, putting an extra level of strain on them.

In the survey conducted by Greephire, 68% of clinical trial participants reported at least some disruption to their daily routines due to required travel or time commitments. The logistics of these disturbances often become too much for someone with a serious illness to endure. 

Out-Of-Pocket Expenses and Affordability

With the increase in decentralized trial models and technology spurred by the Covid-19 pandemic, many would assume trials are more flexible and that less travel is required. In some cases, there are trials that do provide flexibility and hybrid models help to reduce the amount of travel required.

However, when recently analyzing Greenphire data showing distance from the trial site to the participants’ homes, we see evidence that the mileage traveled is further than the 25 miles previously published in numerous industry publications. In fact, in 2022, we saw that trial participants traveled on average 37 miles each way to a trial clinic; however, the therapeutic area dramatically increased, with rare disease participants traveling 120 miles. 

Then there are the out-of-pocket expenses that accompany travel – hotels, rental cars, food. If the patient requires a caregiver, these costs increase even more. In research conducted by the NIH on participants involved in early-stage oncology trials, nearly half of the respondents reported monthly out-of-pocket costs of at least $1,000 with racial and ethnic minorities citing even higher rates due to unanticipated medical costs. 

These financial expenses have been cited as a concern by individuals who are interested in participating in clinical trials. In CISCRP’s 2021 Perceptions and Insights Study, individuals who have never participated in clinical trials cited potential costs and reimbursements as “very important” factors to consider when deciding to enroll in a trial.

Ensuring that sites are getting paid by sponsors on time is critical to helping keep patients enrolled and engaged. The Greenphire research also revealed 82% of sites say that delays in site payments from study sponsors have a negative impact on their business operations. 

In order for participants to get reimbursed and paid for their time, sites must receive payments from sponsors. There are many technology solutions on the market that allow for a streamlined payment process, from study start up to participant payments. When we can ensure participants that being a part of a clinical trial will not carry a heavy financial burden, we’re expanding the population of people who are willing to participate, and especially those within underrepresented populations.

What Can Be Done

There are steps that every clinical trial can implement to increase diverse access for research. The toolkits includes the following three steps: 

  • Step 1: Ask and educate! Diverse participants are likely to participate in clinical trials when asked. 
  • Step 2: Remove the financial and logistical burdens associated with participating in the trial.
  • Step 3: Diversify the workforce. There is a direct correlation between diversity of staff and patient diversity. 

Impacts of Underrepresentation

The genetic makeup of racial minorities can vary from that of the caucasian population. Additionally, other factors such as gender, individuals with disabilities and members of the LGBTQIA+ community can have an impact on the effectiveness or accessibility of treatments.

In order to guarantee the safety and efficacy of drugs and treatments, clinical trials must be designed with all populations in mind. No individual is the same, so what works for a certain population of people, may not work for another, and can sometimes present a risk.

It’s evident that through all of these factors, a large portion of the population is missing out on the chance to help in advancing research for diseases and drugs.

Most recently, there has been such an evolution in the way we conduct and design trials. From what we know about the lack of diversity in clinical trials and through the use of technology we are able to reach more people, provide flexibility, and alleviate burdens associated with participating in a clinical trial.

While progress has been made, the industry should be taking more advantage of the tools we now have to ensure new treatments are accessible and effective for everyone.

Jaleeysa King
Jaleeysa King
Senior Data Analyst and Co-Chair of All In On Diversity Committee at Greenphire

Jaleeysa King is a visionary data analyst who is revolutionizing the link between data analysis, fair market value, and diversity in clinical trials. In her previous role as a Senior Data Delivery Analyst at Greenphire, Jaleeysa was responsible for validating the global fair market value data set and providing insight on investigator grant trends to facilitate more effective site budget negotiations. She has since amplified those skills in her current role as a Business Analyst of Reporting and Analytics driving product innovation. Also, through her in-depth study of the disparities in patient population diversity in clinical trials, she is creating new ways technology and data can be used to bridge those gaps. By providing support to clients through data analysis and industry changes, she continues to find ways to support the broader data vision of Greenphire.