Pamela Tenaerts, MD, MBA, chief scientific officer, Medable; Luke Gelinas, PhD, senior chair director, Advarra; and Pam Diamond, MD, chief medical officer & co-founder, Curavit share their initial thoughts on the announcement of FDA's Diversity Action Plan guidance.
Tenaerts: It was awaited, so we're all happy it came out and I think it's going in the right direction. I think they lay out a logical plan for why this is important and how this should be done, and what you could potentially do to achieve diversity. To bring it back to why this is important, we need to have trials that reflect the intended population. I heard a story yesterday about an oncology patient who's African American—the mother of somebody in our industry, and they were looking at a particular drug, and they had no information about her—African Americans, and that is not right. This highlights the importance of this, and I think sponsors in our industry are wanting to do the right thing, and this helps us get there.
Gelinas: I think it's a step in the right direction. I think the whole clinical trial industry and ecosystem is in agreement that enhancing diversity of clinical trial samples is urgently needed. To get anywhere in life, it's good to have a plan, right? I think it's important to note that these are diversity action plans, so it's always good to have a plan. There are a couple of limitations. One is that, for me, the big question is, is FDA going to find a way to enforce these and to hold sponsors’ feet to the fire, not only in terms of submitting the plans to them, but actually meeting the plans. Are there going to be mechanisms to check in and say,” Hey, you didn't actually meet the plan that you proposed.” Is there going to be any way for us to measure that and then to put a little bit of pressure on people or sponsors who don't? But I think it's good. I think it's a step in the right direction. Again, it's only for Phase III and other pivotal trials, so it doesn't cover all studies, but it covers the big ones, so I think it's good.
Diamond: I do have some initial thoughts. One thing that I think is really good is it's really for better or for worse, forcing us all to think more about what does diversity in clinical trials mean? I think in recent years, we've paid a lot of attention to trying to diversify trials in terms of race, ethnicity, age of participants, sex of participants, but I noticed the guidance is really emphasizing what are very valid considerations to continue to pay attention to what I just mentioned, but also pay close attention to geographical location—does someone live in an urban or a rural location? That constitutes diversity in trials. We also need to pay attention to differences in socioeconomic status or income status, need to pay more attention to disabilities, sexual orientation, gender identity of our participants, so I think the FDA draft guidance has been a good reminder for all of us in the industry that we need to pay attention to things other than race, ethnicity, age, and sex of participants. There are a lot of other important factors that we need to pay attention to increase inclusivity in clinical trials. I also think that I'm hoping that these guidelines will lead to greater trust across the industry, whether it's increased trust between sponsors and regulatory organizations, but more importantly, in my mind, hoping it will increase trust between sponsors, CROs, and potential trial participants.
