19 Jan Inclusive drugs: designing clinical trials for the pregnant population

Experts share why protection by the exclusion of pregnant people leads to a lack of evidence-based medicine and ways to improve clinical trial conduct.

By Urtė Fultinavičiūtė, Clinical Trials Arena

he inclusion of female participants in clinical trials has been a never-ending battle for almost three decades. The historical tragedy of thalidomide has resulted in a lack of evidence-based clinical research and medicine for women who are pregnant or may become pregnant. Even though female participation in clinical trials is slowly improving, the pregnant population is still left behind.

Certain justifications that are routinely used for not including pregnant people in clinical trials should be rethought moving forward, says Miranda Waggoner, PhD, associate professor of sociology at Florida State University. She explains that thalidomide was a tragedy in large part because it was not responsibly studied during pregnancy before it was given to pregnant people. This event had the potential to become a catalyst for expanding and improving responsible studies of drugs in pregnancy, but instead, it led to scientific abandonment.

One of the more recent examples of pregnancy exclusion is in Covid-19 vaccine trials. Like many other viral, bacterial, and parasitic infections, Covid-19 can cause worse outcomes in pregnant individuals, says Dr Richard Beigi, president of UPMC Magee-Womens Hospital. He adds that Covid-19 is an illustrious example of when fear of enrolment translates into the investigational drug being perceived as unsafe.

“Pregnant people experience illness, and they deserve to be prescribed drugs that have been well studied and that are dosed correctly,” Waggoner says. Experts tell Clinical Trials Arena how the lack of clinical trial data burdens the patients and potentially puts them in danger. Also, they explain how to design clinical trials to safely include this patient population. Read more …