What Sponsors Can Expect From FDA's Diversity Action Plan Guidance

ACT: Does the FDA’s Diversity Action Plan guidance create any additional challenges for sponsors? How can they be addressed?

Smith: Well, I think the guidance can create some additional challenges for sponsors, not because of the fact that there's ambiguity or that what's being asked is unreasonable. I think it will create challenges because it's essentially saying to sponsors, there's no silver bullet for achieving clinical trial diversity. If you look at the specific language around community engagement, for example, I think that's the FDA recognizing that trust is a major issue contributing to this problem, and really the only way to address the issue of trust is to figure out a way to connect and be involved in the communities to overcome that trust. I think that part is what sponsors are going to probably have the greatest challenge with. That's not a core competency or core strength of theirs, but I also think there's opportunities for them to partner with organizations and companies that have that as a strength, particularly when it comes to community engagement to overcome those specific challenges.

ACT: In addition to this guidance increasing diversity awareness in clinical trials, what else do you think industry can work on to increase awareness?

Smith: I think there's two elements of this guidance that some people were hoping for or expecting, and that had to do with laying out specific goals for diversity, and the other one had to do with what are the repercussions or ramifications if diversity is not met on a particular study? Neither one of those two are in the guidance, and I actually think that's a good thing. I think it allows the industry to have an opportunity to really learn from best practices and what really works, and to develop those strategies internally and for themselves. I would like to see, in future iterations of this, getting to the point where we have enough data from what sponsors are actually achieving with diversity action plans to start to infuse some goals there that people can hold themselves accountable to do.