FDA to address diversity in new drug and device studies
Posted by on September 3, 2014 - 11:58am

The Women’s Health Research Institute at Northwestern University applauds the recent release of a new Action Plan developed the Food in Drug Administration in response to a Congressional directive to look closer at the inclusion and analysis of demographic subgroups including women and minorities in applications for new drugs and devices.

The Action Plan to Enhance the Collection and Availability of Subgroup Data, released August 18,  includes 27 action steps that address the quality of data collection,  reporting and analysis; barriers to subgroup inclusion in clinical trials; and availability and transparency of sub group data in new drug/device applications.    Members of the WHRI Leadership Council, composed of researchers, educators and clinicians at Northwestern Medicine committed to women health and the study of sex differences will be reviewing and commenting on the plan.   In addition, several Council members will be participating in workgroups helping the National Institute of Health develop guidelines to increase the inclusion of female subjects in all basic science, translational and clinical research.

 

Inclusion of women in medical device studies critical!
Posted by on July 10, 2014 - 9:10am

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

FDA Advocates for Sex as a Research Variable
Posted by on January 24, 2014 - 3:14pm

Men and Women are physiologically different, and it is essential to ensure adequate participation of both sexes in research studies in order to determine sex-based differences in disease presentation, prevalence, and treatment. A press release from Mary Ann Liebert, Inc. Publishers revealed a study that tested the participation rate of women in post-approval studies mandated by the Food and Drug Administration (FDA). Out of their sample size, researchers found that only 14% of studies “included a multivariate analysis that included sex as a covariate” and a meager 4% “included a subgroup analysis for female participants.” These shocking results mean that women are not getting adequate attention in clinical trials, which may result in harmful drug or device reactions in women.

Women vary from men in genetics, hormones, body size, sex-specific physiology, diet, sociocultural issues, and more—therefore, it is incorrect to assume that women and men will react the same way when tested for medical devices and drugs. Most researchers limit sex-based research to areas that are inherently sex-biased, for instance obstetrics and gynecology more often involves women, while urology more often involves men. However, men and women differ in nearly everything from their hearts to their knees—and research needs to keep these differences in mind. If researchers neglect to include sex as a variable in their research, devices and drugs can be approved for public use without fully understanding the reaction such drugs could have on women.

In response to this growing concern, the FDA has implemented new procedures to ensure participation by sex is evaluated in post-approval study reviews. This is certainly a step in the right direction towards recognizing and evaluating sex-specific health responses to new research.

Source: Journal of Women's Health

FDA Gives Hot Flashes a Chill Pill
Posted by on August 26, 2013 - 11:00am

The United States Food and Drug Administration recently approved the first non-hormonal solution to hot flashes associated with menopause; it is the drug Brisdelle.  Nearly 75% of menopausal women experience hot flashes, which are extreme feelings of warmth accompanied with redness and sweating.  While hot flashes can spread over the entire body, they are mostly concentrated in the face and neck. Hot flashes are the most common side effect of menopause, and while the exact cause of hot flashes is unknown, a great deal of research is conducted on alleviating this discomfort for women. This new drug Brisdelle offers a non-hormonal alternative to the hormone therapy options currently available.

Brisdelle contains paroxetine mesylate, a serotonin reuptake inhibitor, which differs from other FDA-approved hot flash treatments that contain the hormones estrogen and progestin. Brisdelle underwent two randomized, double-blind, placebo-controlled studies with 1,175 postmenopausal participants and was found to produce positive results compared to the placebo control. The drug is taken once a day and some side effects include nausea, vomiting, fatigue, and headache.  The director of the Division of Bone, Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, Hylton V. Joffe, M.D., M.M.Sc., expressed that Brisdelle is a breakthrough product for women “who cannot or do not want to use hormonal treatments” for hot flashes associated with menopause. Brisdelle can now be added to the many treatment options available to women who experience symptoms related to menopause.

To read more about Brisdelle, click here.