The inclusion of pregnant women in clinical trials has been one of the most contentious issues of modern science. While we have come a long way since the exclusion of all women of childbearing age, there is still hesitation among scientists to include pregnant women, a vulnerable population, in clinical trials [1]. After all, a fetus comprises a whole added layer of complexity when considering the health and safety of study subjects.
One solution to this problem was to exclude pregnant women from research entirely. However, there are major flaws with this approach. By not including pregnant women in clinical trials, it is impossible to adequately treat them. This predicament has been exacerbated by the COVID 19 pandemic. Universal vaccination may be the key to reopening society, but pregnant women have not been included in SARS-CoV-2 vaccine clinical trials. This lack of representation means we do not know for sure what the benefits and risks of the vaccines might be for pregnant women [2].
To address this issue, Blehar et al. came up with a list of recommendations to increase the recruitment of pregnant women for clinical trials. First, the study recommends changing their classification. Rather than classifying pregnant women as “vulnerable,” the researchers suggest classifying them as “scientifically complex.” This new classification could dispel the fear of including pregnant women in clinical trials while still recognizing that their inclusion requires extra consideration.
Next, the researchers suggest standardizing the existing regulations so that they are not left open to interpretation. Currently, IRBs across the United States express differing opinions on what constitutes “minimal risk” to a fetus, which has led to excess caution on their part and exclusion of pregnant women. While caution is by no means a bad thing, standardizing “minimal risk” may allow more studies with pregnant women to be approved.
Finally, Blehar et al. suggest developing a “pregnancy research agenda” to directly promote research involving pregnant women, as opposed to waiting on current research to do so. By identifying the scientific unknowns that pregnant women still face and leveraging resources to address them, we can design a roadmap for other studies to follow [3].
Sources:
[1] Liu, K. A., & DiPietro Mager, N. A. (2016). Women’s involvement in clinical trials: historical perspective and future implications. Pharmacy Practice, 14(1), 708. https://doi.org/10.18549/pharmpract.2016.01.708[2] Malhamé, I., D’Souza, R., & Cheng, M. P. (2020). The Moral Imperative to Include Pregnant Women in Clinical Trials of Interventions for COVID-19. Annals of Internal Medicine, 173(10), 836–837. https://doi.org/10.7326/M20-3106
[3] Blehar, M. C., Spong, C., Grady, C., Goldkind, S. F., Sahin, L., & Clayton, J. A. (2013). Enrolling Pregnant Women: Issues in Clinical Research. Women’s Health Issues, 23(1), e39–e45. https://doi.org/10.1016/j.whi.2012.10.003