Wednesday, April 30, 2014

Democratic House Senate leaders want "GAO Study on Inclusion of Women in NIH-Supported Clinical Trials

In a prepared statement, Democratic House and Senate leaders requested a "GAO Study on Inclusion of Women in NIH-Supported Clinical Trials"

Here is the release, unedited:

"WASHINGTON, DC- Democratic House and Senate leaders today wrote to Government Accountability Office (GAO) Comptroller General Gene Dodaro requesting a study on the inclusion of women in NIH-supported clinical trials to look at whether the level of participation is sufficient for researchers to provide meaningful results on the applicability of research findings to women and whether the results are being made public.  The letter was sent by Rep. Henry A. Waxman, Sen. Tom Harkin, Rep. Frank Pallone, Jr., Sen. Barbara Mikulski, Rep. Nita Lowey, Sen. Elizabeth Warren, Rep. Rosa L. DeLauro, Sen. Kirsten Gillibrand, Rep. Lois Capps, and Sen. Debbie Stabenow.
In the letter the members wrote, "Participation of women in clinical trials is vital to improving our understanding of how women are affected by diseases and conditions that impact their health and lifespan, whether the illnesses are predominately experienced by women, such as breast cancer or osteoporosis, or affect the overall population, such as heart disease or stroke. ... it is critically important that we understand more about the meaningful inclusion of women in NIH-sponsored trials.  These trials help to shape our understanding of diseases, treatment regimens, and care delivery."

In 1993, Congress first directed the National Institutes of Health (NIH) to research disease and conditions that primarily affect women; to require that NIH include women and minorities in clinical research trials; and to analyze data by sex.   Prior GAO work informed these NIH provisions, but GAO has not examined this important issue for more than a decade."

Text of the letter is available below and online here<>.


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