Recent Legislation Seeks to Include More Women in Clinical Trials

By: | Jun-25-14

<p>Representatives Jim Cooper (D-TN) and Cynthia Lummis (R-WY) introduced <a href="http://cooper.house.gov/researchforallpress">legislation</a> last week that will have a powerful impact on women&rsquo;s health research&mdash;the &ldquo;Research for All Act of 2014.&rdquo; The legislation will be instrumental in getting more women involved in clinical trials and underscores the importance of equally incorporating women in clinical research. </p>
<p>Biological sex differences have long been noted in scientific literature, however according to the Society for Women&rsquo;s Health Research (SWHR), &ldquo;many researchers have been slow to incorporate females equally in clinical research.&rdquo; &nbsp;</p>
<p>NACDS Senior Vice President of Government Affairs &amp; Public Policy Carol Kelly accepted an invitation to serve on the SWHR board of directors in February 2014. In welcoming Kelly, Phyllis Greenberger, SWHR president and CEO, said, &ldquo;Ms. Kelly offers a wealth of knowledge and expertise in making the case for women&rsquo;s health with Congress, federal agencies, healthcare stakeholders and the public.&rdquo;</p>
<p>The Research for All Act of 2014 would address several pressing issues, including:</p>
<ul>
<li><span style="text-indent: -0.25in;">Direct the Food and Drug Administration (FDA) to guarantee that clinical drug trials for expedited drug products are sufficient to determine safety and effectiveness for both men and women</span></li>
<li><span style="text-indent: -0.25in;">Increase the study of female animals, tissues and cells in basic research conducted or supported by the National Institutes of Health (NIH) and require the NIH to track how they are used</span></li>
<li><span style="text-indent: -0.25in;">Direct the Government Accountability Office (GAO) to review and report on women and minority inclusion in medical research at both the NIH and the FDA</span></li>
</ul>
<p style="margin-left: 0in;">In a June 23 letter to stakeholders, SWHR&rsquo;s Greenberger said, &ldquo;Women must be included in all phases of clinical research, and research must be analyzed for sex differences. When we don&rsquo;t know how drugs, medical devices or treatments affect people differently, we are endangering the health and well-being of all Americans.&rdquo;</p>
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2016-12-06T13:24:28+00:00Jun-25-14|Categories: Article|Tags: , |