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For decades, the medical and life science communities have discussed boosting diversity in clinical trials. However, research today is still coming up short. According to a 2019 JAMA study, out of 230 trials leading to FDA oncology drug approvals over the past decade, race was only reported by 63%. 

“We would want representation of trial participants to reflect the population of the disease that’s being studied or the group that’s intended to use the product that’s being studied. So I think, at a minimum, that’s what we would be striving for in terms of the makeup of the study population, amoxicillin antibiotic sun exposure ” Samantha Artiga, vice president of racial equity and health policy at the Kaiser Family Foundation, said during the McKinsey Digital Health Conference Friday. 

While there are many conversations around the shortcomings of clinical trials, there needs to be action. 

“We have to think about how we move from recognition of the issue to actually addressing the issue,” she said. “The other point I would raise, and this came up a little bit in the earlier conversation, is that there’s still racial ethnic data missing for a large share of those trials.”

The data gap

Panelists said data are an important part of fixing this problem. However, the structure of reporting race, ethnicity, income and social determinants of health could be improved. 

“There are still huge gaps in data, particularly by race and ethnicity, with high shares of unknown or missing data across data sets. This is not something specific to clinical trial data, and there are a growing share of people that identify as multiracial, and that trend is only going to increase over time. And so thinking about how people are incorporated into studies who identify as multiracial is going to be something that I think really needs some careful thought on going forward,” Artiga said. 

Institutions have to earn a patient’s trust if the latter is going to hand over their data, according to Dr. Simon Sonntag, CEO and co-founder of Virtonomy. That means there needs to be accountability about where the data is being used and how. 

It’s also important to collect data beyond just race, ethnicity and location. 

“What we see with people making comparators [comparisons] or assumptions that you will be miseducated or of lower education status if you were from a certain zip code, I think is incorrect,” Laura Meloney, program manager at MRCT Harvard, said during the panel. “And I think that some of these things need to be readjusted, and we need to look at the whole portfolio of variables instead of saying that this is going to be a proxy for this other thing. I think it’s a very dangerous territory that we’re finding comfort in because we’ve been using that methodology for some time now.”

Bringing different communities into the fold is important. Cassandra Hui, founder and CEO of Heal Mary, said it’s also important to ask folks about how they identify themselves. 

“I’m more of the belief of how to identify cultural belief systems and actually be able to address those,” she said. 

Having these data can help personalize clinical trials and care in the future. 

“I think that’s the incredible thing about technology is the fact that you can start to create customized experiences based on people’s self identification, based on their self responses,” Meloney said. 

Can tech help? 

Transportation is often a barrier for folks with disabilities or those who are under-resourced. 

“Traveling is one of the biggest issues in clinical trials … mobility is one very important aspect in disability, but unfortunately, also lower income areas have not a possibility to travel,” Sonntag said. 

However, decentralized clinical trials (DCTs) have emerged as a way to reach patients in more locations. Oftentimes DCTs use virtual or remote monitoring tools to capture information in the patient’s home. 

“I think what’s exciting is [COVID-19] has expedited things like telemedicine, remote clinical trials, decentralized trials,” Hui said. “There was a conversation that was being had prior but has reached sort of an acceleration point, which was, to me, very exciting.”

There are still some questions about how much of a role virtual can play in clinical trials of the future. 

“I think that the DCTs and hybrid trials are a flexibility that we need to start planning with. I’m a little cautious about relying on them fully. We haven’t worked out all the support systems like the IRB [Institutional Review Board] processes or the institutional processes for accommodating for DCTs completely,” Meloney said. “Also, how one accesses their medication or even takes the medication themselves … There’s something that is very personal about being in one to one, having somebody talk to you, having somebody gently touch your arm when you’re taking your medication at first, versus being on Zoom fatigued again for another doctor’s visit.”

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