Smith shares his initial thoughts on the guidance and what its impact will be on the industry moving forward.
ACT: What are your initial thoughts on FDA releasing the Diversity Action Plan guidance?
Smith: My initial thoughts on the FDA releasing their guidance on clinical trial diversity is all positive. I know we've been waiting for this for quite some time. It was delayed. There was a lot of discussion about what would be in it, how would it change from the previous draft guidance, and I think that the FDA has done a really great job with providing greater specificity on some of the details that's being requested from sponsors. I also think at the same time, they're leaving a lot of opportunities for sponsors to determine how they best see trying to achieve greater diversity in their trials. So overall, I'm excited to see the guidance and excited to see the continued discussion and focus on clinical trial diversity.
ACT: What will its impact be on the industry?
Smith: I think what you're going to see from sponsors after this most recent guidance is the majority of them will take very progressive and positive steps to try to achieve what the FDA is outlining in the guidance. I think you'll also see some separation. You'll see some sponsors that are saying, “Listen, we're going to invest even more, and we're going to dig deep and go even beyond what is being asked of us in the Diversity Action Plan.” You're going to see some sponsors that are going to, frankly, try to just meet the bare minimum when it comes to what's being requested. Ultimately, what we're going to find is that those sponsors that are making the investment to make sure they have adequate representation in their trials, in their data—so that we know that the drugs have the same level of efficacy and don't have negative side effects, simply based upon a certain subgroup—are going to win overall. You'll see more sponsors putting focus on this, but you'll also, I think, see some sponsors that are becoming market leaders in this particular space.
