Fact: Despite representing half the population, women are woefully underrepresented in clinical trials for medical devices.
As a result, some approved devices can still be unsafe and ineffective for women — despite hundreds of millions of dollars spent on R&D, clinical, approval and manufacturing, as well as sales and marketing.
While a 1994 FDA policy attempted to address gender disparity, the problem persists. A March 2011 study has brought the issue back into the news and the agency has promised a guidance in 2011.
Here’s what you can do in the meantime.
Gender disparity in clinical trials still exists today despite an 18-year-old policy stating that device approval requests must 1) explain if the proportion of men to women in the trial accurately reflects the proportion with the condition who are being treated, and 2) the differences in safety and effectiveness of the device in women.
In fact, the FDA has often approved implantable and other high-risk devices based on trial data that was not broken out by gender or didn’t show the ratio of men to women.
The FDA finally plans to clear things up later this year with a guidance on the topic, but device manufacturers really need answers now.
Rather than wait for the agency, mark your calendar for Wednesday, May 25, when a leading authority on women’s health will share strategies to help you recruit more women into clinical trials.
In 90 fast-paced minutes, Dr. Rita Redberg of the UCSF School of Medicine offers a sneak preview of what the FDA guidance is likely to say, as well as interim policy improvements the agency has released. She’ll clear away mysteries of subject recruitment including:
Reducing Gender Disparities in Device Clinical Trials is convenient to attend. All that’s required is that you be in front of a screen at the appointed time, whether you work at the office or telecommute from your office at home.
Of course, Dr. Redberg will be on hand to answer all of your questions. Simply submit them via email, and you’ll have answers by the time the session ends.
Key people throughout your company will benefit from taking part in this event. Best of all, everyone can do so at a cost that won’t break the budget. You pay one single low registration fee per facility, regardless of how many participate. So spread the word.
Make sure your products function properly in all patients, regardless of gender. It’s healthier for patients, your customers — and your bottom line. Register now.
Everyone involved in clinical trials is likely to want to participate in this session. Spread the word to:
Rita Redberg M.D. is Professor of Medicine, Division of Cardiology, University of California-San Francisco School of Medicine. She also is director of Women’s Cardiovascular Services, UCSF, where she co-founded the Women’s Health Center. She earned her M.D. degree from the University of Pennsylvania and a master's in health policy from the London School of Economics. She is editor of the Archives of Internal Medicine, and founded and directed the Committee on Women in Cardiology of the American Heart Association. As a source on cardiac and women’s health, appears often in The New York Times, Wall Street Journal, USA Today, and on National Public Radio and the Today Show, among other media.
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