Jun 22, 2026 · 25 min · 9 segments
In this episode of ACRO's GCP, Tinaya Gray (Executive Director, Site Engagement & PACE at ICON plc), Jan Hewett (SVP, FDA Regulatory Advisor at Advarra), and Jackie Kent (Independent Advisor) unpack…
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Tinaya GrayGuest
Jan HewettGuest
Jackie KentGuest
Sophia McLeodHost
Well, I think one of the first reasons that we thought this was important to do is the gathering actually has a different audience than a lot of the other events that we participate in.
So we had an opportunity to get some new people, new ideas, right? So we had new people we could bring to the table.
We also worked together in other forums where we wanted to continue the conversations, right? We wanted to be able to come together and really create a path forward that was very implementable, and, and we had those opportunities by using this forum, this group of people, and really focusing on this area of our broader issues that we face every day in clinical trials.
Ha- having been there, I, I think, I think your vision, uh, was certainly felt, uh, within the room, where, you know, we're all clear that on ... at a high level, disease does not affect all populations equally.
We understand that where someone lives, their environment, uh, their genetics, you know, all of this influences not only whether or not a disease shows up, but how early it's identified, how effectively it's managed, right? At the same time, we know that outcomes vary significantly across populations, and that the data that we all rely on to inform clinical decision-making doesn't always reflect the reality.
And I think a really easy, simple example of that is the fact that 4% of the global population, uh, is, is American, or the US population is 4% of, of, of the globe, yet Americans account for 35% of participants in clinical trials, right? And so that disconnect matters.
For sponsors, in addition, like, not only the, does this create an opportunity for us to write that clinical question, but it also represents, I think, a, a market consideration.
And so this dive team was together really thinking about how can we be pragmatic and forward-looking? How do we widen access to research? How do we reduce these inequities in participation? And how do we actually get to the point where we're generating more generalizable data and getting that data in the hands of, um, clinicians and patients for better decision-making? Yeah.
Um, I wasn't part of the original planning for the goals around, you know, what the dive team wanted to accomplish around good generalizable data, but I was very happy to be a part of the dive team, though.
It's, as it's extremely important to me, you know, given my past and current, uh, roles professionally, that we have the right representation for a given clinical trial, and that you have the right data to inform us of the medical products that are investigated and marketed.
So as you, Tanaya, and Jackie laid out very nicely, the, you know, representation matters, um, in terms of the data that's collected and, and the generalizability of it for ethical and humanistic reasons because it really does ensure ...
And having come from the FDA, I'm obviously someone who really hopes that products, uh, you know, uh, marketed, that serve the people fairly, safely, and with respect.
Just the group of people came from all different places and industry and all different locations, and I was just really amazed at how well everybody came together for the topic at hand.
Well, I think one of the first reasons that we thought this was important to do is the gathering actually has a different audience than a lot of the other events that we participate in.
So we had an opportunity to get some new people, new ideas, right? So we had new people we could bring to the table.
We also worked together in other forums where we wanted to continue the conversations, right? We wanted to be able to come together and really create a path forward that was very implementable, and, and we had those opportunities by using this forum, this group of people, and really focusing on this area of our broader issues that we face every day in clinical trials.
Ha- having been there, I, I think, I think your vision, uh, was certainly felt, uh, within the room, where, you know, we're all clear that on ... at a high level, disease does not affect all populations equally.
We understand that where someone lives, their environment, uh, their genetics, you know, all of this influences not only whether or not a disease shows up, but how early it's identified, how effectively it's managed, right? At the same time, we know that outcomes vary significantly across populations, and that the data that we all rely on to inform clinical decision-making doesn't always reflect the reality.
And I think a really easy, simple example of that is the fact that 4% of the global population, uh, is, is American, or the US population is 4% of, of, of the globe, yet Americans account for 35% of participants in clinical trials, right? And so that disconnect matters.
For sponsors, in addition, like, not only the, does this create an opportunity for us to write that clinical question, but it also represents, I think, a, a market consideration.
And so this dive team was together really thinking about how can we be pragmatic and forward-looking? How do we widen access to research? How do we reduce these inequities in participation? And how do we actually get to the point where we're generating more generalizable data and getting that data in the hands of, um, clinicians and patients for better decision-making? Yeah.
Um, I wasn't part of the original planning for the goals around, you know, what the dive team wanted to accomplish around good generalizable data, but I was very happy to be a part of the dive team, though.
It's, as it's extremely important to me, you know, given my past and current, uh, roles professionally, that we have the right representation for a given clinical trial, and that you have the right data to inform us of the medical products that are investigated and marketed.
So as you, Tanaya, and Jackie laid out very nicely, the, you know, representation matters, um, in terms of the data that's collected and, and the generalizability of it for ethical and humanistic reasons because it really does ensure ...
And having come from the FDA, I'm obviously someone who really hopes that products, uh, you know, uh, marketed, that serve the people fairly, safely, and with respect.
Just the group of people came from all different places and industry and all different locations, and I was just really amazed at how well everybody came together for the topic at hand.
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