Bass, Berry & Sims attorney Clint Hermes was quoted in a Law360 article examining the potential and perceived legal barriers to including pregnant women and lactating women in clinical trials. The topic is being addressed as federal regulators are expected to release new guidance shortly on how to diversify clinical trial populations.
As Clint referenced, historically study sponsors restricted clinical trial participation to white men to reduce risk, assuming the results could be generalized to other populations. The result has been that excluded populations are more likely to be diagnosed or treated inappropriately.
Speaking about the anticipated new federal guidelines, Clint said that he is eager to see what the FDA [Food and Drug Administration] has to say about the inclusion of pregnant and lactating people in clinical trials. Its latest guidance on that issue is close to a decade old, and the agency’s thinking may have changed since then, he added. Requirements imposed by the Food and Drug Omnibus Reform Act (FDORA) will have an impact on how the FDA addresses this issue as well.
“From a policy perspective, if we want to get to a place to get sponsors to feel the push to go out of their way to design studies to include these populations, there has to be some combination of incentives and requirements,” Clint said.
The full article, “Misplaced Fears Leave Pregnant Subjects Out of Drug Trials,” was published by Law360 on April 23 and is available online (subscription required).