Mistrust in healthcare is hitting clinical trial enrolment

A survey of pharma industry executives has found that a third of them believe mistrust in the healthcare system has become a significant barrier to getting a diverse range of people to sign up for clinical trials.

The analysis found that historical abuses in clinical trials and negative experiences patients may have experienced with their own medical care have generated a reluctance – particularly among communities with lower socioeconomic status – to participate in studies.

One example of that is the Tuskegee experiments in the 1930s, which exploited African American men to explore the consequences of untreated syphilis, even though an effective treatment (penicillin) was available at the time. Those experiments have “left a legacy of scepticism and reluctance to participate in clinical trial research,” according to Trinity Life Sciences, which carried out the survey.

An IQVIA report found that participation by Black/African American and Hispanic/Latinx patients in US clinical trials has been in decline since 2012, despite efforts by regulators, the pharma industry, and other trial sponsors to improve diversity.

It is well recognised that different groups can have distinct disease presentations or health circumstances that affect how they will respond to treatments, and including a diverse spectrum of subjects in trials can give a more reliable indication of how a new drug might perform in the real world.

Although over 40% of the US population is currently comprised of ethnic and racial minorities, typically only 5% to 10% of clinical trial participants represent any minority population, according to Trinity, which provides commercial services to pharma companies.

The company said the disparity is “striking” and could expose non-white people to harm from a gap of knowledge around what is effective and ineffective – or even dangerous – in minority patients.

With that in mind, the FDA released draft guidance in 2022 describing ways to improve trial participation from underrepresented racial and ethnic populations, which is in the process of being finalised. Trinity’s survey found that some executives felt the current draft may be too vague and lacks clear penalties for non-compliance, which means adherence to them will likely vary.

The report praises GSK for its efforts on diversity, noting that 100% of its phase 3 trials included a diversity plan at the end of 2022, but adds that the company is an outlier in the industry overall in its reporting on the issue.

“Our research findings make it clear that companies are thinking about how to reach diverse populations, but many are also watching and waiting to understand the FDA’s enforcement,” says the report.

Among the strategies to improve minority representation include greater use of advertising and media campaigns to reach underrepresented communities, diversifying pharmaceutical boardrooms, encouraging contract research organisations to widen the net of trial recruitment, and community engagement through venues like churches, social clubs, and barbershops.