By: Paula Johnson, MD

Have researchers been leaving women’s health to chance? Disease must be diagnosed and treated differently in men and women, but research often fails to account for the impact of sex differences.

More than twenty years ago, the U.S. government mandated that clinical trials funded by the National Institutes of Health (NIH) include female participants. This requirement boosted the number of women studied, but not at a high enough rate to account for the impact of disease on women.

A new policy released by the NIH this month has taken another step towards decreasing gender inequity in medical research by requiring that scientists include female lab animals, tissues and cells in pre-clinical research. And a few weeks earlier, Senators Elizabeth Warren and Kirsten Gillibrand asked the Government Accountability Office to investigate whether clinical trials are including adequate participation from women.

These are promising reactions to a report I recently co-authored with my colleagues at The Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital and The Jacobs Institute at George Washington University. Our report, “Sex Specific Medical Research: Why Women’s Health Can’t Wait,” found that doctors are still providing many women with prevention, diagnosis and treatment information based on research that hasn’t sufficiently accounted for sex differences.

Encouragingly, the NIH’s announcement takes many of our report’s recommendations to heart, including the following:

  • Applicants must indicate how they will include male and female cells and animals in preclinical studies when they apply for funding, unless they provide strong evidence why doing so would be unnecessary.
  • Funding agencies must confirm that the design of clinical studies considers the sex of the subject, includes adequate participation from women and reports on sex differences among the findings.
  • NIH will team up with publishers to promote the publication of research that meets and reports on the above criteria.

We’re delighted to see so many of our recommendations addressed so quickly by the government, and we’re encouraged that these changes will help lead to health equity for women and better health outcomes for generations to come.

Watch the video below for the highlights from the launch event on Dr. Johnson’s report.

Topics: Clinical Trials, Innovation, Legislation

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