A global survey of clinical trials in pregnancy

What is it about?

We searched all of the major clinical trial registries around the world for studies that enrolled pregnant women into a drug trial in order to see how many there were, where they were being undertaken, who funded them and what drugs were being tested. We found there were remarkably few trials compared to other areas of medicine (about 50 times less) . Of the trials listed, very few were pharma-funded, and most were evaluations of existing drugs - only three trials were actually of a newly-developed drug being evaluated for treatment of a pregnancy condition. There were also marked differences in the relative amounts of pregnancy drug trials around the world. The current clinical trial scenario is not serving the needs to pregnant women and as a result the majority of drugs prescribed in pregnancy are administered without proper studies of efficacy and safety, with very little ongoing development of new drugs for treating the major pregnancy complications that affect up to 20% of all pregnancies.

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Why is it important?

This study provides for the first time hard evidence to support what has been suspected for many years - that the pregnant women is a drug orphan, and will continue to be so until the barriers that inhibit drug trials in pregnancy are removed. Active steps are needed to improve the situation.