Advarra CEO Discusses Improving Diversity In Clinical Trials

ACT: Where do you think industry currently is with improving diversity in clinical trials?

Saarony: It's not where it needs to be. I say this not tongue in cheek, but with all seriousness, I think there are a couple of things to consider. Everybody talks about diversity and inclusion in clinical trials. Every website you go to, whether it's pharma, sponsor, CRO, or site, It's always front and center. It's all about diversity and inclusion in clinical trials. it's something that the FDA, the NIH, all the regulatory authorities talk about. But, it's one thing to sort of feature it and talk about, and it's another thing to take action, which isn't easy. Before we even get into that, maybe it's important for people to understand why diversity is important in clinical trials. The introduction of new medicine, new therapies for patients in need, and innovation is incredible. The big question is, does it actually include the right swath of the population?

First of all, if you think of clinical trials, they're a care option, and lack of representation really exasperates the health discrepancies in underrepresented populations. Minority populations should have the same access to clinical trials as a care option as everybody else.

The second piece is, if you think about the purpose of the clinical trials, it's really to collect data to figure out which trial is safe, if the medication is safe, if it's effective, and also to collect data that represents the totality of the population which will ultimately end up with the therapy. There could be clinically significant differences in treatment efficacy between groups. If you don't include all of the groups, one of two things will happen. Either the therapy will be restricted to the group that is included, or the therapy may be included for everyone, but may not be as effective. So, from a data collection perspective, it's really important.

From my perspective, lack of representation also compounds what is already a challenge for the industry, which is really low accrual rates in trials. We're not actually accessing as much of the population that can actually qualify for clinical trials, and we are slowly enrolling for these trials. This means that it delays the introduction of new therapies to patients in need. To me, these are all things that are important to consider, and that's why diversity is so important.

ACT: FDA released guidance on diversity in clinical trials back in 2022. How has this helped increase diversity since then and what do you think the next steps should be for regulatory bodies to continue improving diversity in trials?

Saarony: It increased awareness for sure. I wouldn't say that it increased diversity. At least if you look at the data, it doesn't show that diversity has increased meaningfully. Having said that, it does take time for these things to take hold. Remember, it's a guidance, not a mandate or a regulation. I'm not sure it's something that you can regulate. I think we are at least seeing some legislation being introduced as it relates to NIH clinical trials or diversity in clinical trials that NIH at least participates in. They're a funding mechanism, so they can influence and determine what they want to see. To a certain extent, they can also suffer any slowdown in the clinical trials. Those are business decisions that can be made. The reality is, I'm not sure what the FDA can mandate.

I think there are three things that can be done. First, I would say you have to measure what you ultimately want to see results in. I think mandating better tracking of diversity in clinical trials by therapeutic area, by face of trial by type of trial, and by type of platform is very important. When you see the numbers right in front of you, it's a very telling story. When you see it at the macro level, t's one thing, but when you see it at the company by company level, it does tell a different story. It allows you to compare how you're doing relative to somebody else. So, I think the FDA can ask for more data and better data.

The second piece where I believe the FDA can do much better is really around this concept of reducing the burden reducing the burden in these protocols. Maybe it's fewer follow up visits, maybe some of the procedures that they're insisting on that are in the protocol are not necessary. I think the FDA should step in and say, "Look, this is not really necessary to get to the result that you want." I think that the FDA should be more scrutinous of of these protocols and figure out ways by which to reduce the burden. gain, not mandating but saying, if you don't do A, B, and C, it doesn't mean you're not going to get approval or data. Why are you doing these things?

I think the third piece is that the FDA can be really helpful. I think they've done a decent job, not a great job, but a decent job to create that awareness. Go out to the community, talk about these things, and publish more about the importance of diversity in clinical trials. What does it really mean? You don't just need to reach the sponsors or the conductors of the clinical trials, you actually need to go out to the communities where the patients are, because the biggest obstacle to enrollment not withstanding the burden of the protocol is that the patients or the targets of the clinical trials don't want to participate or don't have access to these trials. How do you go to the community to create awareness? I think those are things that you can impact without regulating.