NIH Issues Additional Funding To Study Gender Differences In Clinical Trials

By Nick Otto

The National Institutes of Health (NIH) is investing $10 million in additional funding for scientific trials to encourage researchers to consider gender in their preclinical and clinical studies.

The supplemental money will be provided to 82 projects in preclinical study spanning a range of fields, including basic immunology, cardiovascular physiology, neural circuitry, and behavioral health, the NIH said recently.

The funding is meant to inspire researchers to study both male and female genders as a “fundamental variable in research,” according to the NIH.

To fully understand gender effects on health, the NIH asks that researchers include one of the following elements to their projects:

• The inclusion of animals, tissues, or cells of both genders for gender-based comparisons
• The inclusion of additional subjects of either gender to an existing sample that already has males and females for further analysis of gender differences
• An analysis of existing datasets containing information from males and females

“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,” said James M. Anderson, director of the Division of Program Coordination, Planning, and Strategic Initiatives, which oversees the NIH Common Fund, in the NIH press release.

The FDA earlier this summer issued final guidance advising device makers to consider gender distribution of study participants at different points of a clinical study.

“We think it's an important change and a meaningful change,” Janine Austin Clayton, director of the NIH Office of Research on Women's Health, said about the new policy in a Reuters article. The investment should serve as a catalyst to help scientists view gender as a key variable in research, she added.

The supplemental funding is part of a larger effort by the NIH’s Office of Research on Women's Health to rectify gender inequality in medical research, and this year’s investment brings total support for the program to $14.7 million, the NIH said.

In May, the NIH began requiring researchers affiliated with or funded by any of the agency’s departments to begin reporting on their plans to balance male and female cells and animals in their experiments, according to Nature.