Fair Trials: The Need for Representation in Clinical Trials

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One of the biggest obstacles to medical research is the lack of a truly representative population in clinical trials. For his ENDO Online 2020 session, “Minority Participation in Research: Considerations of Urgency and Strategy,” James R. Gavin III, MD, PhD, will discuss needed steps researchers can take to ensure clinical trials are representative of all patient populations.

 

There is no debate among medical experts that when it comes to chronic conditions, minorities are overrepresented and disproportionately affected by the course and severity of these diseases. The problem here is that the healthcare community is still unsure why that is or  what can be done about it.

If minorities aren’t properly represented in something like a drug trial for a medicine to treat a disease that affects this population at a higher rate, then the data are in danger of being incomplete, since physicians won’t know whether treatments or interventions shown effective in mitigating the effects of such conditions in others would have similar benefits – or adverse events — in minorities.

The first step to solving any problem is admitting you have one, which is why ENDO Online 2020 will feature James R. Gavin III, MD, PhD, clinical professor of medicine at the Emory University School of Medicine arguing for the dire need for more minority recruitment for clinical trials in his talk “Minority Participation in Research: Considerations of Urgency and Strategy,” part of the larger session on Breaking Barriers to Care, and is available on demand.

“Continued participation in clinical studies may become increasingly transactional and incentives will have to be thoughtfully considered. On the other hand, I fear significant levels of dropout.” – James R. Gavin III, MD, PhD, clinical professor of medicine, Emory University School of Medicine, Atlanta, Ga.

“It is essential to have adequate exposure of such populations to the treatments and interventions under consideration in order to make informed judgments about the safe use of these approaches in minority population,” Gavin says. “For the healthcare provider, such knowledge, or its absence, will have an effect on the substance of the conversation the healthcare professional might initiate with the patient regarding what to expect from the proposed treatment plan.”

Cultural Competence

For his talk, Gavin tells Endocrine News that he will summarize the urgency for having a discussion of the best practices to recruit minorities into clinical trials and gathering real world evidence in the clinical setting, both historically and right up to the current COVID-19 pandemic. “I will point out the learnings we have derived from working in this space for many years and outline some of the strategies we have used to increase recruitment and retention (it requires both to merit the designation of participation),” he says.

First and foremost, Gavin says that it’s important to know the demographics of the patient population you’re seeking for your research project, as well as the network of providers who serve them. “It is essential to establish networks of relationships that will assure trusted access to these populations, and it is essential that cultural competence training be provided for all persons engaged in such recruitments,” he says.

Cultural competence training involves educating staff on how to properly engage with diverse population groups,  to close the gaps in these patients’ treatments. Culturally competent care, then, involves some self-reflection and acquiring cultural knowledge — it’s important to be aware of diverse populations’ different approaches to healthcare and how they view healthcare providers. For example, according to Gavin, African Americans tend to have a deep distrust of medical providers because of past experiences.

Gavin will provide some action strategies and approaches on how to break this barrier to care and for increasing minority participation in clinical trials, even as some of those trials may currently be disrupted by COVID-19, a virus that has also disproportionately ravaged minority communities.

Infected Relationships

The current COVID-19 death rate in New York City for Blacks is 20 out of 100,000, and for Hispanics, the rate is 22 out of 100,000. The death rate in New York City for whites is 10 out of 100,000. In Michigan, where African Americans represent 14% of the population, their death rate is more than 40%.

“We are entering a new era of unprecedented displacement and disruption. Many will have lost jobs and not have jobs to go back to. Different levels of pressure will emerge over fundamentals like transportation, childcare, and even food security.” – James R. Gavin III, MD, PhD, clinical professor of medicine, Emory University School of Medicine, Atlanta, Ga.

What’s more, the novel coronavirus pandemic may have infected relationships among minorities and their healthcare providers and researchers hoping to recruit diverse populations for clinical trials designed to help extend lifespans and improve the quality of those lives. Most protocols are not set up for virtual meetings, and it’s much easier to trust someone by sitting down with them and meeting face to face.

“The process of relationship building and cultivation, which are important long-term elements in the clinical research enterprise, just cannot be easily done remotely,” Gavin says. “In many instances, subjects may not be technologically adept or equipped to fully engage virtually. Moreover, it takes time to properly teach about the dangers of this pandemic and the importance of fidelity to rigorous risk mitigation strategies.”

Unprecedented Displacement

And once this is all over, once things return to “normal” and it’s safe to shake someone’s hand or hug a loved one, Gavin says that priorities are different for everyone now, and will be for a very long time. “We are entering a new era of unprecedented displacement and disruption,” he says. “Many will have lost jobs and not have jobs to go back to. Different levels of pressure will emerge over fundamentals like transportation, childcare, and even food security.”

And researchers may have to change the ways they approach recruitment strategies once it’s safe for clinical trials to be conducted in person. “Continued participation in clinical studies may become increasingly transactional and incentives will have to be thoughtfully considered,” Gavin says. “On the other hand, I fear significant levels of dropout.”

Still, the need for minority participation in these research projects and clinical trials is more urgent than ever, especially as COVID-19 has shown the healthcare community that it’s imperative to understand why minorities are so disproportionately affected and adversely impacted by chronic conditions and global pandemics. “This type of recruitment is extremely urgent, doable, rewarding, has lots of learned or acquired elements embedded in the process of doing it successfully, and most importantly, requires legitimate patience and willingness to tolerate differences,” Gavin says.

Bagley is the senior editor of Endocrine News. He wrote about glycemic control in COVID-19 patients in the May issue.

 

 

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