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Industry Leaders Discuss the Impact of FDA’s Diversity Action Plan

Tenaerts: I think it’ll help the industry get more data, actionable data on a diverse population—there’s different ways to do that. You can change your inclusion/exclusion criteria. You definitely work with the communities. It’s also becoming clear that decentralization could be part of the how you get there. You have to have your goals reflect the population and then you have to have the rationale of why you picked those percentages or those things, and then one of the things that’s emerging is that decentralization could be one of those things. We had some recent data come out from the PACT (Partnership for Advancing Clinical Trials) consortium that showed that using decentralized elements, there’s an emerging trend of more diversity, with less white people enrolled and more Asian people enrolled, so I think we want to get more data on that, but it’s important that the industry is moving in that direction, and that we’re all doing the right thing.

Gelinas: It’s going to force industry sponsors to think really carefully about the types of patients they’re trying to reach with their drugs, about what they think representative clinical trial sample looks like. I think it’s going to force us a lot more critically and deeper than we had before about what diversity means and what aspects of it are important in terms of sex, ethnicity, race, gender—those are the ones that FDA guidance is focused on. I think it’s going to be positive in the sense that it’s going to force the industry to step back and say—for each different drug that are assessing or device—what is the patient population that we’re hoping to reach with this drug or device look like in the real world? That’s really what we should be using to draft our diversity plans for clinical trials. We should be trying to capture the patient groups in terms of demographics that you’re actually going to serve with the product, the people who are going to take the drug or device, should it become available on the market. It will be good in that respect, and helping industry to think hard about those things. Again, I think it’s always good to have a plan. This is the first step in actually increasing diversity, but I think there’s more work to do beyond the plan, but again, good first step.

Diamond: I could see a short-term consequence, that early on, it might actually increase the expense that sponsors will have in conducting clinical trials. It will be more expensive to recruit a more diverse participant population, and to retain those participants, but I’m very hopeful that in the long run, sponsors will be able to save both time and money—financial resources—in the long run, because we’ve all seen trials that were not very representative, and a lot of money and time were spent on that trial, and it turned out that—say if it was a drug that was under testing—the drug wasn’t really effective in populations that weren’t part of the clinical trial. I’ve seen numbers like one and a half billion, or even in excess of one and a half billion, to bring a drug to market, so if you spend all that money and then when it goes to market, it really isn’t helping the patients that have that condition and that need that medication, it’s a lot of time and money wasted. Again, I see short run, we might have to spend a little bit more money, but in the long run, I think we’re going to see more efficiency and savings. The other thing I could see happening if we’re all really good at following the FDA guidelines is that more trial activities will be done virtually in order to enroll and retain more diverse participants. We just have so many individuals that don’t live close to academic research sites, or even physical clinical research sites, and it would be really good if we could bring more of those participants into clinical trials. Hopefully, and it’s something that our company, Curavit focuses on, is doing as much of the trial virtually as possible, so that we can engage diverse participants and keep them engaged throughout their trial.