blue connect dots

Myndshft Blog

blue connect dots

June 13, 2023

Socioeconomic and Racial Disparities in Clinical Trials and How They Impact Prior Authorization

by Susan Lawson-Dawson | Healthcare Technology, Prior Authorization

While the intention behind prior authorization is to control costs and promote appropriate healthcare utilization, a mounting body of evidence shows that prior authorization disproportionately affects certain racial and socioeconomic groups, exacerbating existing healthcare disparities. Automating prior authorization helps reduce those barriers, but more work needs to be done.

An article published in RollCall on World Cancer Day 2021 noted, “Disparities in clinical trials have been a concern for decades, but it’s generated more attention as the field of precision medicine has taken off. As targeted therapies become a reality—and as dozens of personalized medicines on the market help patients live longer lives—we must do more to consider differences between people of varying races, ethnicities and gender.”

More diversity in clinical trials is crucial

Racial and ethnic minorities have historically been underrepresented in clinical trials. For example, Mayo Clinic Proceedings notes, “Even though the 2018 US Census Bureau population estimates report that non-Hispanic white Americans represent 60.7% of the US population, non-Hispanic whites of European ancestry comprise more than 90% of the population in clinical trials.” 

Factors that limit minority participation

What’s keeping minority populations out of clinical trials? Contributors to the disparities run the gamut from historical distrust of the medical industry to language and cultural barriers. Let’s take a closer look.  

Lack of trust

In 1932, what’s now known as the Tuskegee experiment began. Spurred by the promise of free medical exams, free meals and burial insurance, 600 African American men in Macon County, Alabama—399 with syphilis and 201 who did not have the disease—enrolled in the study. 

For 40 years, rather than testing for cures, the study focused on observing the natural progression of untreated syphilis. The researchers withheld treatment and did not inform the participants of their diagnosis, even when it became clear in the 1940’s that treatment could cure them and prevent transmission to others. 

When news of the study broke in 1972, public outrage led to the study’s termination and a  lawsuit resulting in a $10 million settlement for the participants and their families. The severe ethical violations, including lack of informed consent and the withholding of available treatment, most certainly contributed to a lasting distrust in medical institutions. In turn, this reduced the willingness of minorities to participate in clinical trials and medical research. As a young Hispanic male told Pew Research, “I’m no test dummy.” 

Unfortunately, it also hinders efforts to include diverse populations in clinical trials today, which is crucial to understanding the full spectrum of responses to medical treatments and interventions.

Inclusion and exclusion criteria too rigid

Many clinical trials often exclude participants with certain co-occurring conditions or comorbidities. For example, trials often exclude those with hypertension, diabetes, or kidney disease, which are more prevalent in some racial and ethnic minority populations. 

Research published in JCO Oncology Practice in 2021 found that only 8.5% of African American cancer patients met eligibility requirements for inclusion in clinical trials, with most patients excluded for comorbidities. Therefore, such criteria can disproportionately exclude minorities from trials.

Socioeconomic status and geographical limitations

While clinical trials typically cover the costs of trial medications, patients may have to cover certain costs related to care, which could disproportionately exclude those with lower socioeconomic status, a group that statistically includes more people of color. 

In addition, people with lower socioeconomic status may be less able to take time off work, afford child care or arrange for transportation to trial sites.

In addition, clinical trials are often carried out in major hospitals or research centers, which are predominantly located in urban areas. This creates a disadvantage for people living in rural areas, a topic we touched on in our earlier look at the impact of prior authorizations on health equity

Language and cultural barriers

Language requirements for participation that demand fluency in a non-native language may exclude otherwise willing clinical trial participants.  In addition, a lack of culturally appropriate recruitment materials or informed consent processes also creates barriers to participation. 

Even when language isn’t a barrier, daily reporting may pose a challenge. Thanks to wide-spread availability of smartphones, the digital divide has narrowed. However, in 2021 Pew Research found that African American and Hispanic adults are still less likely to have a desktop or laptop computer and home broadband. Rather than desktop-only reporting sites, clinical trials should use sites optimized for mobile devices or bespoke apps that make daily reporting less demanding for participants. 

The good news? According to focus groups conducted by Pew Research in 2021, 59% of African Americans and 58% of Hispanics see clinical trials as “very important.”  Now, those running clinical trials just need to figure out how to turn that sentiment into action. 

Clinical trial data heavily influences prior authorization decisions

Where does prior authorization fit into this issue? Once new drugs receive approval, prior authorization creates another hurdle. Payers rely on evidence-based medicine to determine the medical necessity of a treatment. When the available data primarily represent white populations, it can result in a lack of understanding regarding the efficacy and safety of treatments for other racial or ethnic cohorts. 

As a result, medications or procedures that are highly effective for specific racial or ethnic groups may face greater scrutiny and encounter more frequent denials during the prior authorization process.

Case in point: A BMC Cancer article published in 2022 notes that minorities make up 36.3% of the population, but less than 2% of National Cancer Institute sponsored clinical trials focused on racial or ethnic minorities. Yet, Healthline reports that African American men have higher rates of prostate cancer and African American women are 2x more likely to be diagnosed with triple-negative breast cancer compared to their White counterparts. When innovative new treatments and medications evolve without good minority representation during clinical trials, death rates remain higher among the underrepresented groups. 

Automated prior authorization keeps you up-to-date

As efforts to bring more balance to clinical trials continue, prior authorizations software can help. 

Payers frequently modify prior authorization requirements to keep up with novel treatments, procedures and medications introduced. It’s understandable. After all, “new” usually comes at a higher cost. Staying alert to changing prior authorization requirements takes a lot of time if you’re doing it manually. 

For providers in underserved areas with resources already stretched to the limit, a reprieve from excess paperwork makes a huge difference. By automating the process, clinicians and staff have more time to focus on bringing care to patients.

With prior authorization software, the payer library stays up-to-date as requirements evolve. This ensures that when you submit a prior authorization, it includes exactly the information the payer needs. No missing details. And conversely, no extra information to bog down the decision-making process. 

And that’s just a small piece of what an automated prior authorization process can do. 

Want to see what else automation makes possibleConnect with Myndshft