Informing Diversity Goals for Clinical Trials

In a recent interview with Applied Clinical Trials, Rachael Fones, director, government & public affairs, IQVIA, discussed the importance of diversity action plans in clinical trials. Fones emphasized the need for understanding the intent behind goal setting, the ability to stay updated with FDA guidelines, and the importance of a robust population assessment.

ACT: What should trial sponsors consider in working to define and inform diversity goals for trials?

Fones: In this latest version of diversity plan guidance, or the Diversity Action Plan Guidance, the FDA has put goals front and center. They've emphasized goals and then how you're going to get there, and that's really important from the standpoint of that's what they need to know and they need to hear and it's important from an operational standpoint, because if you don't know where you're going with your trial and what you're aiming towards, you certainly can't get there. That said, I think sponsors really need to understand, and we all, as advocates for diversity and inclusion need to remember that it's not just a number. The goal is to better understand your population before you start the trial. That population assessment is so key, and it's one of those things that we found in doing diversity plans is true.

As someone who's done policy on this topic for years, we understand that the intent of this is not just to meet that number, it's to truly understand what the differences are. Is there a difference in effect? To start that off, you need to make sure you do that population assessment and one of the things is in that we found, is that thorough that assessment to truly understand what your population looks like, what differences are in the care journey that a different race or ethnicity may face, a difference in how they present, differences in outcomes. Those things are so critical to informing that goal setting because your goal-setting has to be in context of the population for your trial. It has to not just be, let's say, breast cancer at large. It needs to be that specific type of breast cancer and specific place in the treatment.

Again, the population assessment, what we've found is, not only is it where you can turn your goals into meaningful, yet achievable goals so you understand what that population looks like, but it's also where you uncover some of what I often call the true gold in this. If a population tends to present differently in one condition or another, that's an important nugget from the population assessment. It may not affect your goals, but it will affect your operational plans, and then it also affects your ability to be successful. For example, we've seen populations where perhaps—let's take the Hispanic ethnicity as a group, first of all, we all know that's a simple proxy for a very diverse population—but digging into the literature and understanding, we start to learn things that you may not have seen if you weren't looking for it. For instance, some Hispanic populations, depending on their country of origin, didn't have a high prevalence of disease, but the disease particularly affected the Mexican American population. That is what I call gold that is helpful for planning, for site selection, for informing investigators, maybe even informs how you do your recruitment materials, and informs perhaps your commercial strategy. These are things that prior to doing diversity guidance, we weren't looking at. You assume all people react the same, and you proceed with that in a clinical trial, but diversity planning and doing a population assessment up front is yielding some useful insights, not just for better goal setting, but for better planning and better commercial success.