A critical component of the translation of basic science to new therapies is the extent to which females and males are equitably incorporated in research studies in all phases of biomedical research. At the basic research stage, this includes taking into account the sex of cell lines and animals used in preclinical research studies. During downstream clinical research, this means ensuring that women and men participate equally in clinical trials. The investigation of sex-specific effects is considered by the Society to be a significant component of the rigor and completeness in research.
The lack of proper investigation of such effects may create gaps in understanding of fundamental biological processes or discrepancies between basic research and downstream clinical effects. This inconsistency in the biomedical research pipeline can have serious consequences. For example, of the 10 drugs that were withdrawn from January 1, 1997 through 2001, eight posed greater health risks for women. However, despite years of awareness of this issue, women are still inadequately represented in many clinical trials. Additionally, sex differences are still not routinely considered as a critical variable in basic biological studies.
The Endocrine Society has worked to raise awareness of the issue of sex differences in biomedical research and urge that federal agencies specifically incorporate sex as a critical biological variable in research plans. Recent efforts by the Society include:
• Meeting with congressional offices to discuss the need for federal agencies to incorporate sex as a biological variable in research.
• Supporting a recent effort by a bipartisan group of women senators who called for equitable inclusion of women and minorities in clinical research while urging them to consider similar efforts for preclinical research.
• Advocating that the House Energy and Commerce Committee’s “21st Century Cures Initiative” encourage the equitable study of both sexes in all stages of the biomedical research pipeline, in an effort to optimize overall research productivity.
• Asking the National Institutes of Health (NIH) to ensure that strategic plans and scientific initiatives include a consideration of sex differences in preclinical research.
In response to concerns articulated by the Society and other stakeholders, federal agencies are developing and implementing new policies to more appropriately balance the reporting and inclusion of sex differences in all phases of the biomedical research pipeline. The NIH and Office of Research on Women’s Health (ORWH), for example, recently announced the development of new policies “to balance sex in cell and animal studies” in preclinical research funded by the NIH. The policies will be rolled out in phases beginning in October 2014 and include changes in the grant review process and ongoing engagement with stakeholders.
The FDA’s Office of Women’s Health has been working to ensure adequate participation of women in clinical trials and encourage analysis of data by sex to determine if sex differences exist in disease therapies. In response to section 907 of the FDA Safety and Innovation Act, the FDA will develop an action plan on the inclusion of demographic subgroups, such as women and underrepresented minorities, in clinical trials. The action plan will include recommendations to “improve the completeness and quality of analyses of data on demographic subgroups in summaries of product safety and effectiveness data and in labeling.”
The Endocrine Society has been a leader on the issue of sex differences in research, for instance by advocating for the appropriate consideration of sex as a critical biological variable, and also through leading by example, establishing journal policies that require reporting of the sex of animals used in research. The Society is encouraged by the development of the new NIH policies and complementary efforts by other federal agencies to achieve equity in all stages of the biomedical research pipeline.
The Society will remain engaged with the NIH, ORWH, FDA, and other critical stakeholders as new policies affecting Society members are developed and rolled out. We encourage members to provide input on the Society’s ongoing efforts. To stay on top of new developments, look to new issues of Endocrine Insider. To provide comments and suggestions for staff to bring to the attention of federal agencies, please reach out to the Society’s Government and Public Affairs Department at [email protected].
— Laakso is the associate director, science policy, for the Endocrine Society
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