Should Pregnant Women Be In Clinical Trials?

It's a question that, for years, seemed to have a perfectly obvious answer: "No! Of course pregnant women shouldn't be in clinical trials. They're, well... pregnant, for god's sake! They're probably not in any condition to undergo the risks and rigors of research. Not to mention that subjecting a fetus to the unknown effects of a new drug seems completely unethical!" And let's not underestimate the advice given by company attorneys to avoid the liability for damage done to these women and their unborn babies, even in the most responsibly designed and conducted studies being monitored by the Food and Drug Administration.

That hands-off approach has, for the most part, been abandoned.

Why? What led to the change of philosophy in a relatively short time? It's not due to any less concern over the safety of research subjects. In fact, it's due primarily to a greater concern for the safety of patients.

Back when pregnant women were not included in clinical trials, it was noted that recently-approved medicines were being prescribed for adults - all adults, including those who were pregnant! As a result, pregnant women (and their fetuses) were being exposed to drugs which were never tested for safety or effectiveness in pregnant women in the first place. And that seemed even more unethical than the status quo.

Federal regulations now call for testing of drugs and devices in the populations in which they are anticipated to be used. This may pose somewhat greater risk to clinical trial participants, but it is intended to reduce the risk to many more patients once the drug or device is approved and marketed. Better to be looking for side effects in a population under careful control than in the population of patients at large.

-Joe

Related Topics: Dangerous Drugs During Pregnancy, Prescription Guide for Patients

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