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Manufacture Clinical Trials, Standards & Regulation, Small Molecules

Time for Pharma to Deliver?

The adequate inclusion of women in clinical trials is an issue with an increasing level of awareness – and it’s a topic The Medicine Maker has covered previously (1)(2). But there is one particular group of women who continue to be far more underserved by clinical research: pregnant women.

And there’s a good reason the problem should not be ignored: according to the FDA, half of pregnant women report taking at least one medicine (3). Worrying then that, of the 172 drugs approved by the FDA between 2000 and 2010, 97 percent had an “undetermined” risk for pregnancy. Perhaps worse, for 73 percent of new drugs the amount of data available on safety in pregnancy was rated as “none” (4). Every day, pregnant women need to make decisions and balance the risks to their own and their unborn children’s health when deciding to take – or not to take – medications for which no clear guidance is available. Often, the health care professionals advising them can’t offer much help either, for the same reason: the data they need simply doesn’t exist.

I spoke to doctors, researchers, and those within the pharma industry to understand the depth of the problem – and how it should and could be addressed.

Pregnant Patients Deserve Better
A Pharma Success Story
Including Pregnant Women from the Start
A Tall Task
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  1. S S Sutton, “What Women Want”, The Medicine Maker”, 44, 8–9 (2018). Available at:
  2. R McGuigan, “Cherchez la Femme?”, The Medicine Maker, 38, 14 (2018). Available at:
  3. US FDA, “Medicine and pregnancy”, (2018). Available at: Accessed October 2, 2018.
  4. MP Adam et al., “Evolving knowledge of the teratogenicity of medications in human pregnancy”, AM J Med Genet C Semin Med Genet, 157C, 175–182 (2011). DOI: 10.1002/ajmg.c.30313.
About the Author
Roisin McGuigan

I have an extensive academic background in the life sciences, having studied forensic biology and human medical genetics in my time at Strathclyde and Glasgow Universities. My research, data presentation and bioinformatics skills plus my ‘wet lab’ experience have been a superb grounding for my role as a Deputy Editor at Texere Publishing. The job allows me to utilize my hard-learned academic skills and experience in my current position within an exciting and contemporary publishing company.

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