Inclusion of women in medical device studies critical!

Most people know that human clinical trials are critical to prove safety and efficacy in new medications.   This is also true for medical devices yet a recent study indicated that only 14% of device studies included sex as a key outcome measure, and only 4% included a subgroup analysis for female participants.    The differences in anatomy and physiology, as well as other factors in men and women,  can lead to devices working less effectively and safely.

The FDA’s Office of Women’s Health  recently supported a study of clinical trials conducted on cardiac resynchronization therapy (CRT), a pacemaker therapy for patients with heart failure.  Only 22% of the clinical trial participants were women.   By combining multiple studies and mining the multi-study data, the FDA Center for Devices and Radiological Health (CDRH) found that women benefited more than men from CRT.

This particular study demonstrates that we need adequate samples of men and women in studies early in the research process.   The good news is the FDA is taking two steps to insure more sex inclusion is built int0 future studies:

  • The FDA will finalized a guidance document that provides a clear framework for the inclusion of women in device studies
  • Mandated by Congress, the FDA will release an Action Plan, that will further address the analysis of data on women and product and safety data in labeling for drugs and devices.

How can you help??  Ask you doctor if there are clinical studies looking for subjects or contact your local medical school.    If you live in Illinois, you can join the Illinois Women’s Health Registry  a gateway to clinical trials in Illinois.

Source:  FDA VOICE, June 23, 2014

Having babies later may extend life

Women who had their last child at age 33 years or older were more likely to reach extremes of longevity, according to an analysis published online June 23 in Menopause.
Women who had their last child when they were aged 33 to 37 years were twice as likely to reach the extreme fifth percentile of longevity compared with women who had their last child before that age.

“Prolonged fertility may be a marker of slower aging,” write the authors, led by Fangui Sun, PhD, from the Department of Biostatistics at Boston University in Massachusetts. Previous studies, including some on historical data in the 17th, 18th, and 19th centuries, had found that women who had their last children late in life tended to live longer and to have siblings who lived longer.

Dr. Sun and colleagues analyzed data from the Long Life Family Study, whose participants have multiple family members who have reached extremes of longevity. The population includes sets of siblings selected because of their collective longevity scores, along with their spouses and children. The families were recruited between 2006 and 2009 in Boston; Pittsburgh, Pennsylvania; New York City; and Denmark.

One hypothesis to account for the association between maternal age and longevity, write Dr. Sun and colleagues, is that women whose bodies use energy more efficiently are able to both avoid age-related diseases and have increased fertility. The authors suspect these women would also be more likely to have more children, but in this study, they found a nonsignificant association in the opposite direction: having 3 or more children decreased the likelihood of extreme longevity.

The authors note that twin studies have suggested that genetics only explain about 20% of variation in longevity but that the influence of genetics increases at older ages. In other words, environmental and behavioral factors may influence a person’s likelihood of living to their mid-80s, but in the extremes of old age, genetics play more of a role. They suggest that studying the genetics of fertility may reveal genes that influence longevity.

The Long Life Family Study was funded by the National Institute on Aging/National Institutes of Health.
Menopause. Published online June 23, 2014.

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