FDAnews Announces — Gender Distribution in Device Clinical Trials: The FDA’s Increasing Emphasis on Sex-Specific Data Webinar, April 29

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In August 2014, the FDA issued its long-awaited draft guidance, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies,” 28 pages of recommendations that will steer device sponsors down a new path. Mark the calendar for Thursday, Dec. 4, when two leading device researchers help device sponsors understand and cope with this still-evolving area of government oversight.

Gender Distribution in Device Clinical Trials:
The FDA’s Increasing Emphasis on Sex-Specific Data
**FDAnews Webinar**
April 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/genderdistributiondeviceclinicaltrials

Despite FDA prodding, recent device clinical trials include only 22% women.

If clinical trials are not balanced device sponsors could be risking delayed or denied approvals, lawsuits from plaintiff’s attorneys, and some of the worst publicity they could imagine.

In August, the FDA issued its long-awaited draft guidance, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies,” 28 pages of recommendations that will steer device sponsors down a new path.

Plus, Congress is pushing this issue hard. On Nov. 17, a bipartisan group of US senators sent a letter to HHS asking for the inclusion of women in all phases of heart health research conducted by HHS, FDA, CDC and CMS, including analysis and publication of gender-specific data.

Mark the calendar for Wednesday, April 29, when two leading device researchers help device sponsors understand and cope with this still-evolving area of government oversight. Attendees will discover:

  • The FDA’s two key moves to reduce gender disparities in device clinical trials
  • Three case studies where medical devices were approved from data in men — and women did much worse
  • Strategies to increase representation of women in device clinical trials
  • Strategies to incorporate gender-specific data in clinical decision-making
  • And much more!

The presenters will spotlight how the new guidance may affect trials — things to watch out for, stumbling-blocks to avoid.

Even today, three years after the FDA entered this area with its draft guidance on gender differences in clinical trials, devicemakers and clinical-trial design specialists still struggle with getting gender balance right.

Don’t jeopardize a device clinical trial.

Meet the Presenters:
Rita F. Redberg MD MSc, is Professor of Medicine, Director of Women’s Cardiovascular Services at UC-San Francisco and Chief Editor of JAMA Internal Medicine. Dr. Redberg has spearheaded the journal’s new focus on health care reform and a “less is more” approach that highlights areas of healthcare with no known benefit and definite risks. Her research focuses on high-value care employing high-risk medical devices, as well as the need to include women in clinical trials of such devices. She is often quoted in The New York Times, Wall Street Journal, USA Today and National Public Radio, and as a Today Show guest. A cardiologists, she also holds a MS in Health Policy and Administration from the London School of Economics.

Sanket Dhruva MD is a fellow in cardiology at UC-Davis Medical Center. He and Dr. Redberg have been researching gender disparities in medical-device clinical trials and FDA regulation, and Medicare coverage of medical devices, for the past seven years.

Who Will Benefit:

  • Clinical trial design specialists
  • Medical affairs professionals
  • Compliance officers
  • Consultants/service providers
  • Clinical data management and statistics personnel

Webinar Details:
Gender Distribution in Device Clinical Trials:
The FDA’s Increasing Emphasis on Sex-Specific Data
**FDAnews Webinar**
April 29, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/genderdistributiondeviceclinicaltrials

Tuition:
$487 per site -- includes webinar registration and audio cds and transcripts

Easy Ways to Register:
Online:     http://www.fdanews.com/genderdistributiondeviceclinicaltrials
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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