NIH Adds $10M to Encourage Gender Balance in Clinical Trials

NIH Adds $10M to Encourage Gender Balance in Clinical Trials

NIH Adds $10M to Encourage Gender Balance in Clinical Trials

These strategic investments help incorporate sex into existing funded studies, U.S. health officials say

SOURCE: U.S. National Institutes of Health, Office of Research on Women's Health, news release, Sept. 23, 2014

TUESDAY, Sept. 23, 2014 (HealthDay News) -- The U.S. National Institutes of Health is investing $10 million in additional funding in scientific trials to encourage researchers to consider gender in their preclinical and clinical studies.

The supplemental monies were provided to 82 projects spanning a range of fields, including basic immunology, cardiovascular physiology, neural circuitry, and behavioral health, according to an NIH announcement Sept. 23.

"This funding strategy demonstrates our commitment to moving the needle toward better health for all Americans, while helping grow our knowledge base for both sexes and building research infrastructure to aid future studies," Dr. Janine Austin Clayton, NIH associate director for women's health research, said in an NIH news release. "The scientists receiving these awards have approached their research questions with fresh thinking, and are looking for innovation and discovery through a new lens."

Preclinical trials are currently more focused on men, which can mask key findings related to sex and gender that could impact future studies, the NIH said.

"By making strategic investments that incorporate sex into existing funded studies, we are paving the way for researchers to better understand when sex matters in their research," Dr. James Anderson, director of the Division of Program Coordination, Planning, and Strategic Initiatives, which oversees the NIH Common Fund, said in the news release.

The trials that receive the supplemental funding will study men and women and add to the body of sex-based knowledge. To do this, scientists must add one of the following elements to their original project:

  • Animals, tissues, or cells of the opposite sex to allow sex-based comparisons,
  • More men or women to a sample that already includes men and women, to enable an analysis of a sex or gender difference,
  • An analysis of existing datasets containing information from men and women.

The NIH said the investment should serve as a catalyst to help scientists view gender as a key variable in research. The supplemental funding is also intended to created awareness of the need to study both men and women.

More information

The U.S. Food and Drug Administration has more on women in clinical trials.

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