Supporting Clinical Trial Sponsors in Achieving Greater Diversity

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 are some of the key ways that you are seeing small-to-mid-size pharmas, biotechs, and medical device companies may need support to meet expectations and make tangible progress in improving diversity in their trial programs?

Fones: So much of the work that we do in advising sponsors on diversity action plans and how to meet the expectations of the FDA in context of their overall trial goals or overall program goals, is really helping them, the individuals within the team, who are all coming at it from different perspectives, really understand not just the why from a social justice standpoint and health equity standpoint, I think everybody understands that, but what the intent of the goal-setting and the process and that truly, this is not just about the numbers, it's not just about improvement. It's about learning and it's about showing the work, putting in the effort, exploring the populations and what the impact might be, so that you can then set those meaningful goals. I don't know that you could say that this is a difference between small, medium, and large because we're all talking to individuals within a sponsored company. It just might be the difference of where that sponsor is in their journey and where the individuals are and understanding this, but it's really important to help the operational people feel comfortable that what's being set is achievable. It's helping the regulatory team that may or may not have experience on this, fit this in with other regulatory documents. This is not something that's set in stone, it is evolving. It's really marrying that. Where did the policy intent for setting goals and doing the diversity action plan come from, and then how does that work within the context of your trial? Being able to answer those questions and help the sponsors proceed with that confidence, that what they're setting is meaningful to the efforts that's acceptable to regulators and achievable for their operational teams is really a key value add that we can provide.

What we're going to see is, with it becoming required, is the volume of diversity plans will, of course, match the volume of your trial. Some sponsors may have several trials launching at once and not be able and by several trials launching once, maybe one promising product that they're trying on different populations, which will necessitate different population assessments to get to those goals or they only do one every year. Being able to utilize and tap into others who do these on a regular basis, we're able to stay on top of what the FDA is saying and what they're doing, and again, marry it with what we already know and what we're seeing, and leverage those efficiencies. That said, doing the diversity plan efficiently is great if you don't have that cross-functional team and SOPs built up to do that, but really doing it right to get your trial on the right track and bring that value-add is where I think it's really, I found, it's really helpful for us, even working with large sponsors, everybody's approaching these differently. I think we're all learning from each other, but I can say, our approach to that population assessment is really robust.

Lastly, like I said, it's a moving target. It's going to continue to change. Different reviewers are going to have different feedback. It's really important to understand those nuances, and we at IQVIA have been in a position that if we work across different sponsors, we're able to leverage those insights and deliver plans, again, that are built specifically for the sponsor in that program, yet are acceptable to regulators and implementable on the outside. Hopefully, as this gains traction, what we will see is all sponsors and folks involved in drug development start to see that value, gain that comfort with diversity planning, and it just becomes business as usual.