The National Academies of Sciences, Engineering and Medicine (NASEM) has published a paper on issues surrounding the involvement in clinical trials of pregnant and lactating women.

The paper includes discussions from a June workshop held by NASEM’s Forum on Drug Discovery, Development and Translation in which a range of stakeholders, including subject matter experts, sponsor and FDA representatives, academics and patient advocates, addressed the lack of trial evidence this population faces for many medicines.

Overall, many workshop participants expressed concern that there has not been enough headway made on this issue despite attention and effort over the years. But with many initiatives still underway, there is hope that serious change will soon be realized.

Ruth Faden, founding director of the Johns Hopkins Berman Institute of Bioethics, characterized the issue as “both a glass-half-full and glass-half-empty story.”

“Although there have been intensive efforts in recent years to increase the inclusion of pregnant and lactating persons in clinical trials, pregnant and lactating persons were still excluded from the initial COVID-19 vaccine clinical trials,” the workshop report reads.

“Nevertheless, many groups have come together in recent years around the crucial need to improve representation of pregnant and lactating persons in clinical trials, including NIH, FDA, industry, clinicians, academic researchers, the National Academies, and pregnant and lactating persons themselves.”

It is now time for that collaborative group “to make that next big push,” Faden said.

Topics discussed at the workshop included:

• The impact of evidence gaps on the clinical treatment of pregnant and lactating women as well as challenges faced by these patients and their willingness to participate in trials;
• Legal considerations, including how liability is often named as the main reason for their exclusion from clinical research and potential strategies to reduce legal risks and enable their inclusion by default;
• Lessons learned from COVID-19 and mood disorder trials and perspectives from researchers, sponsors and advocacy groups;
• Practical suggestions for the inclusion of this patient population, as well as factors that impact inclusion;
• Promising innovative approaches to evidence generation and how to facilitate their implementation, the use of real-world evidence and ways to improve safety in postmarket trials; and
• Future opportunities for improving the inclusion of this patient population.

The workshop discussion will be the focus of an upcoming NASEM consensus study that will deliver practical recommendations for tackling the hurdles faced by pregnant and lactating women in clinical research.

Access the workshop proceedings here: https://bit.ly/3FVXO7M.