Delivering on Diversity: How do we move the needle?

In our Delivering on Diversity series, we’ve spoken with Clinical Ambassador CEO and Founder Allison Kalloo about a variety of topics related to minority engagement in medical research.

This episode is the second installment of our analysis and response to the Caroline Chen and Riley Wong’s ProPublica article that provides a deep view into the reasons how a lack of minority participation in clinical trials plays out in drug approvals and, ultimately, health outcomes.

In this installment, we explore the reasons government entities and pharmaceutical companies give for not pursuing minority engagement more aggressively, and discuss what’s truly needed to move the needle. If you haven’t already, listen to the first installment for important background information for the discussion.

You can listen to the full episode here, or read the highlights below. 

(Music by Bensound)

Lindsey Wahlstrom-Edwards (LW): I want to take some time now to dig into some of the arguments that the article puts forward.

In one of them, the FDA acknowledges that the lack of diversity in trials betrays key ethical principles of medical research, but they don’t institute quotas or guidelines for minority engagement. One doctor from the FDA, Dr. Rachel Sherman, the FDA’s principal deputy commissioner notes that diversity of women and children has improved and that people need to balance need for diversity against need to get drugs to market.

She has a direct quote in there saying: “When it comes to clinical research in this country, there’s a credit card, and there’s a limit on the credit card. If we spend on one thing, it won’t get spent on another. We have to be judicious in what we require and what we demand and what we encourage.”

The article goes on to list a few potential trade offs to diversity, and some of these have some real implications. So there’s the cost in time and expense; it costs millions of dollars every day that a drug is delayed. There are delays in enrollment that lead to delays in getting drugs to market, where they can, in theory, help everyone.

I guess there’s big but in the article that they put forth, which is a study by the University of California San Francisco, which shows that eliminating disparities in clinical trials would save costs through disease prevention and improved treatment. Pharma can come back, though, and say that could use data from international studies to offset diversity in the United States, which would eliminate, for example, the need to enroll African Americans.

I don’t know. This, especially the quote, feels a little like shirking responsibility. Because if we can make progress with (white) women and children we can make progress with minorities, too. We just haven’t found the right way to promote engagement and I would guess that is likely due to deep seeded issues like structural racism and lack of understanding of diverse populations among the people responsible for recruitment. What’s your take on that argument, Allison?

Allison Kalloo (AK): It absolutely is shirking responsibility. The excuses are exhausting and abundant. While you and I both work to improve patient recruitment, we still hear fear-based projections from industry about the supposed costs of conducting recruitment tailored to minorities. But my response to that is two-fold. First of all, although they are starting to, they don’t really know what’ it’s going to cost because they’ve never really done any systematic minority recruitment. And secondly, we do already know what the human cost is of persistent health disparities as perpetuated by unequal access to health care.

LW: Right. The article also touches upon was post-marketing (or phase 4) studies, which are studies run after a drug is approved and goes to market to better understand how the drug impacts diverse populations.

The article cites one example of Johnson & Johnson’s prostate cancer Zytiga, which ended up performing better in minority populations in the post-marketing study. In addition, the FDA can conduct surveillance post-approval with their Sentinel system, which eviews medical claims and outcomes. And that would help us understand real-world health outcomes by different populations.

AK: Right. What I would say at this juncture is that Johnson & Johnson got lucky. Because they found out that it worked better than they were anticipating. What if it had been the other way around?

Instead, let’s think in terms of efficiency. Why use a protracted, multi-phase approach to clinical studies and then complain about how long it takes to get something approved?

Let’s prioritize the way industry and institutions do, in terms of economics. The World Health Organization acknowledges that the economic consequences of poor health can be substantial on both a micro and a macro level. The economic calculus is actually a trifecta, if you will, of unnecessary burdens: (1) The excess costs to national health care budgets in their coverage of a sicker population; (2) the excess costs to the labor force covering chronically ill workers and managing sick days and disability; and (3) not to mention the costs of correcting mistakes made by the vacuum of solid medical data— each of those factors has both wide and deep consequences. And if segments of the population cannot afford access to your drug, not only are you doubling down on what amounts to discriminatory practices, you’ve done your bottom line a disservice as well because you can’t expand your market. Ignoring patient diversity and taking a scatter-shot approach does not a cost-savings make. It’s short-sighted at best.

Working smarter rather than harder applies in this instance, too. Investing in advanced planning, culturally-congruent community collaboration, and solid budgeting -- and doing so early rather than doing what is usually done which is waiting for rescue, or waiting until the FDA demands more pharmacovigilance and post-market studies, or waiting until the FDA issues a black box warning, or worse. It seems wiser to get ahead of this.

The FDA’s Sentinel program is good in that it documents outcomes, but waiting to see what happens or waiting until people get hurt and recalling the drug hardly seems ethical or even prudent.

LW: I think we both agree that it’s better to get the right people into the study before you start instead of waiting for these post-market solutions when things don’t go well. But one thing we’ve touched on before and that they also mention in the article is that study protocols are not always designed with minority populations in mind. And that may be a very strong understatement. So let’s talk about that a little bit. Let’s talk about study protocols and how the design of the study can impact minority participation.

AK: It’s clear to me that all protocols should be designed with minorities in mind. The Browning of America— the U.S. Census projections estimating that minorities will be the majority by the year 2050— seems to justify it. The fact that health disparities cut across so many therapeutic areas justifies it. There also seem to be very few medical issues that don’t impact minorities. Research is that scientific and intellectual exercise designed to find these things out. That’s what discovery is all about and including minorities is pivotal in that process.

Having said that, designing study protocols with minorities in mind means not allowing the inclusion criteria to be so restrictive that minorities are barred from participating due to the tendency of some minorities to experience more co-morbidities and present with more complicated or severe medical histories or diagnoses.

Until our healthcare system reflects this truth and industry has consequences for inadequate representation, I’m afraid that so-called “best practices” in clinical research will remain an enigma and conjecture at best. Speculation. We don’t really know how good diversity in clinical trials can be because the system is not really set up to support or demand this level of accountability. And we cannot get there from here without changing it from the very top.