#5-43E. Protecting Pregnant Patients Through Research: Deconstructing the Evidence Gap in Rheumatology (Lancet Rheumatol, 2024)

How often do you find yourself hesitating when prescribing medications for pregnant patients with rheumatic diseases due to a lack of clinical evidence? This pivotal review addresses the persistent exclusion of pregnant individuals from clinical trials, which stems from a historical "protectionist ethic" and results in a critical medical evidence gap. The authors highlight various structural, ethical, and regulatory barriers, such as GDPR compliance and lack of funding, which force clinicians to rely on animal data or observational studies. Crucially, the paper advocates for a profound paradigm shift from protecting pregnant patients from research to protecting them through research, introducing innovative trial designs like adaptive platform trials and Bayesian information borrowing. However, as a Series review based on expert consensus rather than newly generated empirical data, readers must critically evaluate the practical feasibility of these designs in real-world settings. Ultimately, this article is essential for clinicians to understand current pharmacological limitations, embrace shared decision-making, and advocate for more inclusive, evidence-based obstetric care.

Citation: Schreiber, K., et al. Challenges of designing and conducting cohort studies and clinical trials in populations of pregnant people. The Lancet Rheumatology. 2024. DOI: 10.1016/S2665-9913(24)00118-8

URL: https://doi.org/10.1016/S2665-9913(24)00118-8

Disclaimer: This audio summary is based on personal interpretation and does not guarantee the exact content of the original paper. Please refer to the original article for details.