“We realise that even if we solve this with all of CVS’s patients, we touch a third of the population,” Garrick said. “There are still another two-thirds of the population that we don’t currently serve on a regular basis. So, we will, one, share the roadmap, frankly, because we think it serves US public health. Secondly, we’ll also engage with regulators at FDA and other places as FDA begins to implement some of the policy from recent legislation around, say, having a diversity plan as part of your research, what that could or should look like, and we can give some examples of what has worked well and what hasn’t worked well.”
Ultimately, it will take collaboration between pharma sponsors, research sites large and small, tech solutions, and, of course, patients to reach the goal of diverse, representative trials.
“I think this is a really complex problem,” Beatty said. “It’s not going to be an easy solution that gets there.”