COVID-19 Highlights Need for More Diversity in Trials

COVID-19 affects certain demographics differently than others. It has shed new light on the underrepresentation of diverse populations in clinical trials. This issue has always been prevalent in trials, but now with a worldwide pandemic pushing pharma companies to create a COVID-19 vaccine that works for everyone, it has become even more prevalent.

In this interview, Jody Casey, vice president, healthcare partnerships at Elligo Health Research, highlights how the pandemic has put the spotlight on diversity in trials, how Elligo is working with physicians to make studies more accessible, as well as what is in store for the future of appropriate representation in trials.

Andy Studna: The underrepresentation of diverse populations in trials has been a problem for a long time. How has the COVID-19 pandemic shined even more light on that issue?

Jody Casey

Jody Casey: It’s showing that trials cannot be done “business as usual,” and that sponsors cannot only go to their typical vaccine sites where they’ve always run vaccine trials. There needs to be a greater breadth of population and diversity in trials. Because a COVID vaccine is so critically important for all Americans, it’s been brought to light the fact that trials are generally lacking in diversity. In such urgent times, especially with COVID affecting certain demographics differently than others, it’s important that we have a vaccine that works for everyone.

AS: How will Elligo be using its own research experience to identify these patients and their respective demographics that usually get left out of trials?

Casey: It’s all about the communities Elligo brings research to; we have a lot of reverence for that physician-patient relationship in a healthcare setting. We think that’s very sacred, so we go into local communities and enable physicians to run their own trials within their own patient populations. Elligo is in communities that are very diverse. The population of El Paso, Texas, for example, is over 80% Hispanic. We are running a very important, non-COVID-related trial there with two doctors who are bilingual.

Elligo is already in diverse locations and communities of color working with, as an example, an African American psychiatrist who is part of the National Medical Association (NMA), the largest and oldest national organization representing African American physicians and their patients in the United States. He’s also the CEO/president of Bay Pointe Behavioral Health Service, Inc., and South East Houston Research Group. It’s not just about our experience running trials, but where we’re running them. We are already there and have that footprint.

AS: What kind of data is Elligo using to identify these patients?

Casey: A unique aspect of Elligo is that we securely access electronic health record (EHR) data from our physician partners. Sometimes within that EHR data, there is a designation for ethnicity that can help identify patients who otherwise wouldn’t have the opportunity to enroll in the trial because the patient wouldn’t know about it, or they wouldn’t have access. That is one way, but because Elligo has doctors in these communities already, it just naturally occurs.

AS: How does the communication between physicians and their patients change when the patient transitions into being a candidate for a trial?

Casey: Often, the relationship with the physician is there and the physician is usually the one in the practice talking to the patient about the trial. The physician has the background information on their patient. This gives our physicians and their networks other care options for their patients.

AS: What does the future hold for the representation of diverse populations in trials knowing the work that Elligo is doing right now?

Casey: I feel very positively about the future. So many healthcare challenges in this country can be addressed if we just start talking about them directly and doing something about them. We need to go into communities, provide access to patients, and do the hard work of bringing them healthcare and research options. Elligo’s model is working so well that I believe it will be more broadly adopted. We will see much more of this community-based, physician-led research across the country.

Andy Studna is an Assistant Editor for Applied Clinical Trials. He can be reached at astudna@mjhlifesciences.com.