October 23, 2015

GAO Report: More to Be Done to Improve Inclusion of Women in NIH Clinical Research

Washington, D.C. - Today, Senators Patty Murray (D-WA), Barbara Mikulski (D-MD), Elizabeth Warren (D-MA), Debbie Stabenow (D-MI), Kirsten Gillibrand (D-NY), and Representatives Frank Pallone (D-NJ), Nita Lowey (D-NY), Rosa DeLauro (D-CT), and Lois Capps (D-CA), released a report from the Government Accountability Office (GAO) evaluating the inclusion of women in clinical research supported by the National Institutes of Health (NIH). The report shows that while the NIH has made progress in including women in clinical research trials, there is still more work to do to improve reporting and analysis policies to further ensure women are being accurately represented.

"I am pleased that progress has been made in efforts to include women in clinical research trials, but this report makes clear that more work must be done to improve our understanding of how diseases impact women," said Senator Murray. "NIH research is vital to keeping our families and communities healthy and should benefit all people. I'm going to continue pushing for action as we work toward this important goal."

"For far too long, women were being excluded from clinical research trials and women's health issues were being ignored. As this report shows, we've changed that paradigm, but we're not done yet," said Senator Mikulski. "Twenty-five years ago, women did not have much to celebrate when it came to scientific advances - we weren't even at the table. Now researchers look at disease in a gender-specific way, and we've made great strides in breast cancer and cervical cancer research, AIDS research, and mapping the human genome. We must continue to raise awareness, raise consciousness and raise hell so that women are not left behind when it comes to their health."

"The GAO report shows that there is work to be done to do to make sure that women are being routinely and meaningfully included in all clinical research at the NIH," said Senator Warren. "Women are half the population, and it is NIH's job to make sure our research investments are advancing health care for all Americans. My Senate colleagues and I will be working closely with the NIH to ensure that the deficiencies at the agency are rectified as rapidly as possible.

"This report stresses what we already know -- it's critical that women be represented in health studies," said Senator Stabenow. "In order to make sure we get the best treatments possible for conditions like heart disease, Alzheimer's and cancer, medical research must consider the physical differences between men and women from the start."

"We know that diseases affect men and women differently at every level, from symptoms to risk factors and outcomes. Over the years, we have improved clinical research trials done through NIH to more accurately represent women so that we can better understand those critical differences," said Energy and Commerce Ranking Member Frank Pallone, Jr. (D-NJ). "But there is still more to do to ensure the findings of potentially life-saving research benefit all those who are sick, regardless of gender. As a husband and a father of two girls, I know how important it is that we continue working to make clinical research more inclusive."

"We know that diseases impact women differently and that women respond to treatments in different ways," said Congresswoman DeLauro, senior Democrat on the subcommittee responsible for funding the Department of Health and Human Services (HHS), which includes the NIH. "Unfortunately, this GAO report clearly shows that the NIH is not doing enough to collect the critical data we need to properly treat women. I am glad the NIH has recognized they need to improve their efforts in this area and I will be monitoring their progress closely."

"We have made great strides to ensue NIH clinical trials include women to better understand gender differences regarding diseases and treatments, but we haven't crossed the finish line. This GAO report makes clear that the reporting and analysis of women included in NIH clinical trials must improve," said Congresswoman Lowey. As Ranking Member of the House Appropriations Committee, I will continue working to ensure that NIH address shortcomings and improve the collection of research data so all Americans, regardless of gender, may benefit from the most complete medical research available."

"For too long, women have not being adequately represented in clinical trials. As a result, medical treatments may not be as safe and effective for women as they may expect," said Congresswoman Capps. As the GAO study has highlighted, more must be done to ensure that women are not only included in trials, but that analysis on potential sex differences is conducted and reported. Only then can providers and patients truly make the best treatment decisions for them."

Read the report here.

Key findings from the report:

  • NIH has made important progress in ensuring women are included in clinical trials, but the benefits of that inclusion could be magnified by bolstering reporting and analysis policies.
  • While women are at least equally represented in clinical research funded by the agency overall, NIH's current implementation of the rules regarding the inclusion of women in clinical research do not provide data below the institute or center (IC) level. Without this data, it's impossible to know whether women are being sufficiently included when it comes to research regarding specific diseases or conditions.
  • The Women's Health Advisory Committee, the body charged with overseeing NIH's progress on inclusion of women in clinical research, doesn't have access to information on women's inclusion in clinical research even at the level of the IC. Rather, they are only able to consider data that looks at the agency as a whole. This compounds problems in assessing NIH's progress on inclusion of women in clinical research.
  • NIH does not collect summary data on how many studies are required to analyze their data for differences between sexes, or on whether studies required to conduct these analyses actually complete them. Without summary data on funded trials, it is impossible to effectively oversee implementation and assess necessary changes to the inclusion policy.