In the Lancet, Jane E. Salmon, MD, rheumatologist and senior scientist at HSS and colleagues discuss the challenges of conducting studies on postmarketing approved medications, specifically assessing pregnancy outcomes in women with rheumatic and musculoskeletal diseases.

Despite the growing need to understand the use of drugs to treat these diseases during pregnancy, clinical trials involving pregnant patients are rare, and pregnant individuals are routinely excluded from premarketing trials. As a result, safety data on treatments like disease-modifying antirheumatic drugs rely heavily on post-marketing observational studies.

The article highlights the scarcity of observational and interventional studies on the relationship between rheumatic diseases and pregnancy and stresses the need for greater trust and engagement with patients in research, alongside measures to protect both the pregnant person and the fetus.

Read the full article at thelancet.com.