In the healthcare space, the issue of patient diversity in clinical trials is a problem that continues to endure. Over the years, many have raised the question whether sufficient efforts, on the part of stakeholders, have been made to tackle this problem head on.

Pharma consultant, Lisa Valtierra, a leading expert on the topic of racial diversity, feels not enough has been done. With many years of experience working within the industry, Valtierra helps companies gain access to minority markets in the US. In this compelling interview, she explains to CTA how the issue of racial diversity, runs deep in the US health care system.

Clinical Trials Arena: Could you explain why there’s such a dearth of ethnic minorities who take part in clinical trials? Does it boil down to a lack of information within these communities about participating in clinical trials? Or is there a negative stigma attached to clinical trials?

Lisa Valtierra: I think the issue is multifactorial. More so than anything I think it is historical patterns, so for instance if you go back to when clinical trials formally started decades ago, they were done in white men because that’s just how it was. If you look where all the research institutes are in the US, they’re pretty much in areas where white people live and they tend to be affluent. Additionally, the physicians were pretty much white men, so that essentially became the pattern of the way things were done.

Fast forward to now, we still have the same institutions in the same locations with pretty much the same kind of teaching going on. What’s crucial is that the mindset needs to change and we need to broaden the aperture in terms of who gets included in this data. I feel as though there isn’t enough consideration of the genetic differences and or commonalities, so we don’t even know if medicines work as well in ethnic minorities as they do in whites unless we have sufficient numbers to see if that’s the case.

CTA: As you alluded to briefly, what are your thoughts on the lack of diversity on the part of health care practitioners?

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LV: Again, historically, white people went to college and then to medical school. Luckily, that’s changing – there’s a much bigger pool now of women in the medical profession. I think on balance, women outstrip men going to medical school, which is fantastic. Also, we have a lot more people, for instance, of Indian descent becoming physicians and nurses. Nevertheless, in the US at least, what we still lack is training in cultural sensitivities so that physicians and nurses can really talk to their patients from different backgrounds in a way that makes sense to encourage them to even join a clinical trial.

What’s more, you mentioned there’s a lack of information and that’s also true. There are some cultural nuances that might discourage a person from looking into a clinical trial further. That might be because they just don’t understand the process or wouldn’t know what questions to ask and then the physicians don’t know, or they make assumptions that this person won’t want to join because they’re from a certain culture, and that might not be the case.

CTA: In your experience, what would you say needs to be done in order to encourage more patients to participate in clinical trials?

LV: With a concerted effort from all stakeholders, what we need to do is let people know that they matter, and that they need to be counted if they want future medications to be effective for them, their families and their future generations. When people think of clinical trials, automatically they say they don’t want to be a guinea pig. What they don’t understand is that medications only get approved because they can show efficacy and safety. But if they’re not included in that data then we will never really know if it will work for them and later down the road when they might need something it may or may not work – we won’t know. That’s the piece that’s complicated, but we need to do a better job of informing people of the merits of participating in a clinical trial by making it a public health issue.

CTA: In that sense, do you feel there’s some headway being made?

LV: No, I don’t. In the past 20 years, when the National Institutes of Health (NIH) first started reporting on this circa 1995, 5 percent of participants in clinical trials were ethnic minorities. To this day that number has not changed. There may be some individual trials where they solely focus on African-Americans or Hispanics, but that is not a concerted effort across the board. We are looking at diseases like heart disease and diabetes that are over indexed in these populations. It is not OK that they are not represented in numbers that could show differences or similarities among the general population. For that reason, I don’t think any headway has really been made at all, and the same applies with women. We’re forgetting that women aren’t equally represented in clinical trials. You can argue there are some, but those studies might be gender-specific, like ovarian cancer. So not much headway has been made and more needs to be done.

CTA: And to that end, why aren’t there more women involved in clinical trials?

LV: It’s a complicated question. If we can enrol women for clinical trials in breast cancer or ovarian cancer, then why aren’t they being included for heart disease and so forth? Part of the reason is trial design. If you look at studies that are gender-specific they tend to make more accommodations for women to join because they work, have kids and have various other commitments and responsibilities. If the clinical trial design included that for whatever the trial, then more women would be willing to join.

CTA: Do you feel as though if the HCP (health care professional) workforce was more diverse (i.e. more black/Hispanic physicians, female nurses, etc.) that would encourage greater diversity among patients?

LV: I think that is part of the solution – we certainly need more diverse investigators. In fact, I would be thrilled to see more physicians of diverse backgrounds. We should be training them to be investigators and the same can be said of nurses as well. But we also need to train HCPs on how to talk to their patients. If a white woman from Alabama is working on a site in the Bronx; she needs to know how to communicate,connect and gain trust with her patients who might be from all different backgrounds.

CTA: Lastly, are you hopeful we will reach a point when things have changed for the better?

LV: The awareness is high in the industry from all stakeholders. I think everybody recognises that things need to change. The good news is that there’s enough technology to make these changes easier – for instance, we can keep in touch with patients once they’re enrolled in a clinical trial through mobile devices, which is something that couldn’t have been done before. We’re poised at this very sweet spot that if there is enough willingness we can start getting more people involved in clinical trials, and that’s the good news.