FDA Launches New Efforts to Encourage Trial Participation Among Diverse Women

Dr. Marjorie Jenkins, MD, MEd, FACP, Director of Medical Initiatives and Scientific Engagement with the Office of Women’s Health at the FDA

Dr. Marjorie Jenkins, MD, MEd, FACP, Director of Medical Initiatives and Scientific Engagement with the Office of Women’s Health at the FDA

The U.S. Food and Drug Administration (FDA) will hold a series of webinars—bolstered by new resources that include white papers and a toolkit from the National Institutes of Health (NIH)—designed to encourage women across ethnic, economic, and age spectrums to participate in clinical trials.

“You have to plan for diversity,” says Dr. Marjorie Jenkins, MD, MEd, FACP, Director of Medical Initiatives and Scientific Engagement with the Office of Women’s Health (OWH) at the FDA. “It won’t just happen.”

The FDA’s ongoing effort includes two webinars conducted via the Association of Clinical Research Professionals (ACRP) as part of both groups’ efforts to spread this important message, says Ruth Geller, MHS, ORISE Research Participant, OWH.

ACRP members are the foundation of many effective programs for increasing diversity in trials. In this regard, clinical research coordinators (CRCs) are a key to success, says Kimberly A. Thomas, Director of Outreach and Communications at OWH. “It can’t happen without clinical researchers,” she explained.

Research hasn’t been able to pin down exactly why women aren’t asked to participate as often in clinical trials as men, but there are a number of other factors at work, including such commonly cited barriers as:

  • Lack of time due to responsibilities such as work and caregiving
  • Misperception that women of reproductive potential should not participate in clinical trials

Additionally, there are some barriers specific to the participation of some subpopulations within the overall female population, including:

  • Women with low English proficiency (due to language barriers)
  • Racial/ethnic minority women (due to historical instances of unethical research conduct)
  • Rural women and low-income women (due to lack of access to transportation)

The webinars will offer a number of concrete tips to help CRCs and others broaden their participant base. For example, it is important to be cognizant of the seemingly simple matter of logos and photos used to market a trial. In some cultures, the use of a photo or logo of a relatively thin woman connotes poor health. However, an HIV study in Atlanta seeking to bring in more female African American participants had great success with a logo of an African American woman wearing a nice pair of Georgia Peach earrings, Dr. Jenkins noted.

Diversity is a top FDA priority, Dr. Jenkins added. “We want to help improve the quality of clinical trials and data to help inform better decision-making” at the FDA, she said.

Webinar Details

Planning for Diversity – November 1, 2016

Boost recruitment and retention by learning new approaches for creating research environments that foster effective communication and outreach to diverse patient populations. Hear from FDA Commissioner Robert M. Califf, MD, and learn about the FDA’s Diverse Women in Clinical Trials Initiative. Dr. Jenkins will provide a brief background on the inclusion of women in clinical trials, including the role of the FDA Office of Women’s Health. 

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 Recruitment and Retention – November 9, 2016

 Learn practical strategies for overcoming the barriers that can derail provider-based and community-based recruitment of diverse women. Better understand the role of family members in patient decision-making and learn methods for maintaining participant connections that can improve retention.

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Author: Michael Causey