NIH Commits $10 Million To Investigate Role Of Gender In Clinical Studies

The National Institutes of Health (NIH) has pledged $10 million to 82 grantees to investigate gender in clinical studies. The federal health agency announced the funding in a press release, saying it represents a “transformative shift” in life science R&D. The effects of gender on preclinical and clinical studies have been a growing issue in U.S. research and in other countries as well. Janine Austin Clayton, M.D., NIH associate director for women’s health research, said, “The scientists receiving these awards have approached their research questions with fresh thinking, and are looking for innovation and discovery through a new lens.”

The NIH funding will be awarded to current grant holders to give their research a boost in exploring the effects of gender in the drug development process. Investigators will study males and females as a “fundamental variable.” Currently, researchers are relying on male subjects, especially in preclinical studies, which doesn’t necessarily give a clear picture of how the drug would fare in female patients. Obscured data leads to miscalculations in future studies, the agency says. Funding gender-related research brings greater awareness to the issue and reinforces the value of gender studies in research.

The funding follows the NIH’s commentary published in Nature, informing stakeholders of its intent to develop policies for gender research. NIH directors said that the purpose of the commentary was to raise awareness of the importance of gender as it is currently not an important issue for most scientists. Additionally, the letter to Nature outlines the NIH’s plans for change including changing policy, increasing oversight, adjusting review processes, and reaching out to investigators for collaboration. Those programs are rolling out now, with a Request for Information from researchers and stakeholders and other activities to begin this fall.

The new awards are drawn from the NIH Common Fund and will be dispersed in 18 supplements to existing grantees. The projects include behavioral health, cardiovascular physiology, immunology, and neural circuitry. The NIH expects the process and the results to have implications for many life science disciplines.

Specifically, the NIH wants researchers to use cells, tissues, or animals of both genders in preclinical studies. The agency would like investigators to add more samples or subjects of both genders to existing studies, and it wants grantees to examine existing datasets for information regarding the differences in males and females.