Thursday, June 17, 2010

NEJM: Enrolling Pregnant Women In Clinical Trials

 

 


# 4654

 

 

 

One of the more worrisome aspects going into pandemic of 2009 was the sheer lack of data on the safety of using antivirals on women who were pregnant.  

 

Public Health officials very early on had to weigh the benefits of their use during pregnancy against largely unknown risks.  Since that time, we’ve seen studies that have shown these drugs were used to good effect (see Study: Antivirals Saved Lives Of Pregnant Women)

 


In truth, the same situation exists for a wide range of drugs, since clinical trials often exclude pregnant women altogether.  

 

Clinicians are often put in the uncomfortable position of having to assume that these drugs will work in the same way, and at the same dosage, in pregnant patients.

 

Yet we know that pregnancy alters a woman’s metabolism, and down regulates her immune system.  Changes that conceivably could change the way some medications work in their bodies.

 

From the New England Journal of Medicine today we get a Perspective article on the need to enroll more women in clinical trials.  

 

This is a good article, and well worth reading.

 

Enrolling Pregnant Women in Research — Lessons from the H1N1 Influenza Pandemic

Sara F. Goldkind, M.D., Leyla Sahin, M.D., and Beverly Gallauresi, M.P.H.