How to Collect Robust Data on Pregnancy Drug Safety

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Pregnant women are usually not included in randomized clinical trials, but it is vitally important to understand the safety risks they face with medications. Research currently relies mostly on pregnancy exposure registries to gather data for safety studies once drugs are on the market.

RTI Health Solutions researchers Andrea Margulis and Elizabeth Andrews believe that, for many of those studies, there is a better way to collect that data - by using existing health databases. It has been their experience that studies using these databases can be done more efficiently and may even be more scientifically rigorous/inclusive. 

In the United States, the FDA usually requests that data from pregnancy exposure registries be used in postapproval safety research. An exposure registry can take years to complete though and is likely to include fewer subjects than a health database. Margulis and Andrews believe that the time has come for a shift in the way postapproval pregnancy safety research is conducted. They believe that the benefits of using database studies far outweigh the benefits of using pregnancy registries alone. In addition, they recommend multinational collaboration, which could exponentially increase the available data.

In an article published in Pediatrics, the authors shared, “As researchers involved in multiple types of studies of medications in pregnancy … we believe it is time to turn our attention and resources to multidatabase studies to evaluate many medications for conditions often encountered by women of childbearing potential. These programs can efficiently generate robust results to inform treatment decisions in pregnancy with far greater impact on the population at large than reliance on only pregnancy exposure registries.”


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