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May 29, 2014

NIH Engages Women in Medical Research

The National Institutes of Health has unveiled new policies that will engage women in all phases of medical research.

The National Institutes of Health plans to engage women in all phases of medical research, according to commentary recently published in the science journal Nature.

Released by NIH Director, Francis S. Collins and NIH Office of Research on Women’s Health Director, Janine Clayton, this paper unveiled new policies designed to eliminate gender disparities in research. Passed in 1993, the NIH Revitalization Act requires women to be included in all clinical research funded by the NIH, specifically trials conducted just before FDA approval. Thanks to this requirement, more than half of NIH-funded research participants are now women. But the problem remains that females are underrepresented in the early phases of medical research, like studies involving cells and animals.

Cell and animal studies provide important information which guides clinical trials in humans. The problem is that most research relies heavily on male animals and cells, which creates a problem further down the road. Once studies are conducted in humans, women tend to experience much higher rates of adverse drug reactions than men. In fact, it’s estimated that between 1997 and 2000, 80% of the drugs taken off the market caused more adverse events in women vs. men. Experts believe that including female and male cells in early phases of research could help catch these differences before studies are conducted in humans.

The NIH is now actively working to address these issues by introducing new policies that require inclusion of females in the early phases of research. These policies will be rolled out beginning this October with hopes of transforming how science is done. The Society for Women’s Health Research, a nonprofit dedicated to transforming women’s health through science, advocacy and education, commends the NIH for their efforts but points out that change will take time. Including women equally in all phases of medical research will not be immediate and we still have a long way to go to eliminate gender differences in research. Still, new policies requiring females to be included in early phases of research is a great step to ensuring that women are represented at every stage of medical research.

Questions for You to Consider

  • What is a clinical trial?
  • Clinical trials are research studies on human subjects that help answer specific questions about the safety and efficacy of treatments. Clinical trials are strictly regulated to protect the health and safety of study participants.
  • What are the different phases in clinical trials?
  • Clinical trials have three distinct phases, each of which has different goals. Phase I and II clinical trials are used to demonstrate that a new treatment is safe for a small group of people and determine how well it works. Phase III clinical trials compare the new treatment with standard treatments in a large group of people. After passing a phase III trial, researchers can then submit an application for FDA approval.

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