• RKes Starling

How to address racial disparities in clinical trial data

Updated: Jul 6







Amanda Barrell


In the US, fewer than three per cent of eligible patients participate in clinical trials – a figure that drops drastically when applied to ethnic minorities living in underserved communities.

It’s a problem that has repercussions across the healthcare ecosystem, and the impact of disparity on the medical evidence base will only magnify as we further move into the personalised care era.

“We do have evidence that indicates that some therapies do not work in certain genetic dispositions,” said R’Kes Starling, Chief Executive Officer and founder of Texas-based Reveles Clinical Services, a clinical research support company

“According to the American Cancer Association, when you look at breast cancer in African American women, for example, we know that the TP53 mutation is expressed more than Caucasian tumour samples. It is present in some people with an African ancestry but not in others. We need to understand more about that.”

Low clinical trial participation in general, and among black and ethnic minorities in particular, must be addressed if we are to realise the potential of medical advances, he added.

He said: “We are experiencing a tremendous amount of innovation and the number of breakthrough treatments coming through at the moment is unprecedented.

“However, this process still takes anywhere between 12 and 15 years and costs about $2bn. At that pace and with the amount of time and the amount of capital it takes to develop a therapy, it is inevitable that we will start seeing a decline.”


Diverse barriers

Most investigators now understand the importance of diversity in clinical trials but turning this realisation into action isn’t necessarily straightforward.

The barriers to participation among black and ethnic minorities in the US include awareness, access, and a lack of trust spawned of historic medical abuse scandals such as the Tuskegee Airmen study.

“There are so many barriers. You tend to have a lack of knowledge that trials are happening, and a lack of access – on average, patients live two hours away from the investigation site,” said R’Kes, explaining that research-rich sites were often based in large cities and coastal areas.

“Then, for certain groups, you have this trust issue – and that’s not totally unwarranted. We have a history where unscrupulous events have occurred to people of colour and this has led to distrust in the purpose of clinical trials.”

The 40-year Tuskegee trial, for example, was ruled to be unethical in the 1970s, after it emerged syphilis treatment had been withheld from the black participants in the 1940s when penicillin was found to be curative.

“Any one of these barriers is significant, but when you compound them, you can see why we have such low participation rates,” said R’Kes.


Diverse solutions

There’s no “silver bullet” to overcoming these challenges, but the strategy has to start with addressing – and removing – some of these barriers.

Reveles is currently partnering with Black Men in White Coats to help develop more black principal investigators. Founded by Dr Dale Okorodudu, the organisation provides mentorship, guidance and networking to African American trainee doctors.

“We have an epidemic of under-representation in the medical schools. By wrapping a support system around these young men and women, the organisation is creating an eco-system that allows them to thrive in their profession,” R’Kes explained.

Part of that entails encouraging young doctors to develop an interest in conducting research within their own communities, a goal R’Kes believes can help overcome barriers.

“When patients are asked where they get their information about clinical trials from, the number one source is their physician. So, we need to get more diversity in our principal investigators.

“If you have trusted healthcare providers in your community, who look like you, are culturally relevant and understand the challenges associated with those communities, it helps to foster trust, as well as promote the practice of medicine,” he said, adding digital technology solutions also had a role to play.

Reveles provides decentralised clinical trial services by leveraging purpose-built software that utilises techniques such as remote monitoring, telehealth, wearables and electronic patient-reported outcome assessment.

“We know there are barriers associated with geographical disparities. Some people are unable to travel, or certain conditions can prohibit them from travelling. We want to enable them to participate if they are willing and engaged.”

This approach can also help address similar issues in areas like rare disease drug development, where small patient numbers make clinical trial recruitment difficult.

“People with these complex diseases cling to a notion of hope, and by participating in clinical trials they are not only giving hope to themselves but to others. We want to bring that hope closer to home,” said R’Kes.

He added that there was a lot of great work currently going on in the clinical trial technology space, but that embracing its opportunities would require a “paradigm shift”.

“Trust is earned over time and we believe that if we continue to demonstrate that you can conduct a trial in this way, people will begin to embrace it. What was considered an unconventional approach will become the norm over time,” he said.


For the good of the whole

Clinical trial recruitment and retention is an issue that cuts across groups and therapy areas, slowing drug development and medical understanding. But racial disparities pose their own unique problems in terms of contributing to health inequalities across the board.

As personalised care becomes a reality, we are increasingly in need of population-specific data on which to base treatment decisions. Without it, today’s rapid medical advances will simply not benefit the whole of society equally.


This blog was originally posted on pharmaphorum here.

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