Ashley Moultrie of Javara Shares Thoughts on FDA’s Diversity Action Plan Guidance

ACT: What are your thoughts on the FDA’s recently released Diversity Action Plan Guidance? How will this affect sponsors moving forward?

Moultrie: I am a strong proponent for what gets measured gets done, so I strongly believe having the industry guidance—once finalized and put into action—it'll require a level of accountability that I think a lot of folks may have been working towards or figuring out, but having that requirement makes it real. I think it sets a precedent for what has to happen, and I think folks will start moving more intently towards those goals. It's when somethings are nice to have versus when it's a must have—I think we move differently, we allocate resources differently, we discuss planning, and things like that a bit differently when things are required. That requirement piece, I think, is necessary, and we've seen the shift already with just the guidance coming—the ways in which things are changing. Once the guidance of finalized and it's moved out, I think that that change and that shift is going to happen much more robustly.

I think for our sponsor partners, one of the biggest things to consider is how it's going to affect implementation. We may have to adjust how we handle timelines and how we set these goals, there may likely be more time spent up front and figuring out of how to disseminate and when we're going to do trial selection, where are we going to place these trials, who are the investigators are going to look at? But again, that level of accountability, I think, is going to force a lot of us, and not just sponsors and CROs, at the site side as well, to do things a bit differently and consider things a bit differently and prepare differently so that we can meet those goals.