March 30, 2016

Outcomes from SWHR’s Multi-stakeholder Workshop on Achieving Meaningful Subgroup Data in Clinical Trials Released


March 30, 2016

Leslie Ritter

Outcomes from SWHR’s Multi-stakeholder Workshop on Achieving Meaningful Subgroup Data in Clinical Trials Released

WASHINGTON, D.C. (March 30, 2016) —The Society for Women’s Health Research (SWHR®) released the outputs of its two-day workshop “Achieving Meaningful Subgroup Data in Clinical Trial Design and Development: Scientific Approaches and Considerations.” This workshop was held in Washington D.C., on January 27-28 and included participants from academia, industry, and patient advocacy groups. SWHR convened this multi-stakeholder workshop to develop information to share with the Food and Drug Administration (FDA) and other stakeholders on:

  1. Understanding the drivers of variability in drug response among different patient populations
  2. Improving the drug development and approval process
  3. Refining communication about variability in responses to medications to patients and healthcare providers.

Meeting outputs, released in a slide deck format, include recommendations and areas of alignment among the participants and are available on SWHR’s website.

Science has shown medications work differently in diverse patient populations, meaning  medical products that may be safe and effective in some patients may be less effective or harmful in others. This has been a major concern to patient advocacy groups, industry, researchers, and the FDA.

Meeting participants were invited based on their relevant expertise and placed into teams within the three topic areas listed above. The workshop outputs were generated around questions raised in continued conversations surrounding the FDA’s 2014 Action Plan to Enhance the Collection and Availability of Subgroup Data, with the goal of providing direct feedback to the Agency.

The workshop planning committee consisted of representatives from the Biotechnology Innovation Organization, Boehringer Ingelheim Pharmaceuticals, Inc., Brigham and Women’s Hospital, Johns Hopkins School of Medicine, the Pharmaceutical Research and Manufacturers of America, Quintiles, and SWHR.

“By releasing these materials today, it is our hope that the FDA will utilize the information provided in a way that will improve and further the dialogue regarding clinical trial design and subgroup data, ” said Phyllis Greenberger, MSW, SWHR President & CEO.

“We know that biological sex, gender, racial, and ethnic differences cause variability in drug response, but we hope that having the summary information from this meeting will allow for a better discussion around improving clinical trial design and ensuring that these subgroup differences are incorporated into development and approval processes.”

The meeting materials are available on SWHR’s website.




About SWHR

The Society for Women’s Health Research (SWHR®), is a national nonprofit based in Washington D.C. that is widely recognized as the thought-leader in promoting research on biological differences in disease and is dedicated to transforming women’s health through science, advocacy, and education. Founded in 1990 by a group of physicians, medical researchers and health advocates, SWHR aims to bring attention to the variety of diseases and conditions that disproportionately or predominately affect women.

For more information, visit Follow us on Twitter at