For years clinical trials of drugs have centered around men. Women were not considered for many clinical studies mainly out of concern for the fetus should she become pregnant during the trial period. During the 1970s if a woman was in her childbearing years the FDA prohibited her from participating in an early stage drug trials. At first sight, this policy seemed reasonable for protecting unborn children from unforeseen complications; however, it also set the stage for results skewed toward men.
The Necessity of Female Participation in Clinical Studies
In recent years the tendency of focusing on men has changed as the importance of including women in observational and clinical studies has come to light. An example of the necessity of including women can be seen in studies on a heart attack. Most research concentrated on men and how they experienced heart problems.
As studies began to include women, the data revealed that they experience a heart attack differently from men. In particular, women under the age of 55 were less likely to receive needed care for their heart attack symptoms because they were not the same as a man’s. Now, women have a better chance of receiving interventions and having electrocardiograms and other diagnostic testing performed when they present with symptoms.
Pregnancy and Clinical Studies
Recently the FDA released new guidelines for including pregnant women in clinical studies. While this remains an area with murky waters because it involves pregnant women, it is also an area of growing interest. There still seems to be some debate as to whether clinical studies involving pregnant women should consist of only pregnant women or if some of these individuals can safely participate in clinical studies involving women who are not pregnant.
Support for Women Participating in Clinical Trials
Since the early 1990s, policies have been in place to include women and minorities in clinical research funded by the National Institutes of Health (NIH). This move has helped to ensure that studies designed to help the general population are actually reflective of the population. In addition to the inclusion of women in clinical studies, this decision has expanded research regarding women’s health. Studies also consider sex differences as research has shown that the bodies of men and women do not necessarily react in the same way to certain drugs.
The field of research itself has opened more doors through which women pass as they pursue careers in women’s health research. Women’s voices needed to be heard and as a result, they have provided many opportunities to help create a healthier future.
DM Clinical Research has been working for more than a decade helping bring new treatments to the medical field through our research. We welcome people to join our clinical studies and help create a healthier world. Contact us for more information about the work we do and how you can participate.