FDA’s Gottlieb Challenges Investigators to Help Boost Trial Participation by Women

FDA Commissioner Scott Gottlieb, MD

FDA Commissioner Scott Gottlieb, MD

To mark National Women’s Health Week, Food and Drug Commissioner Scott Gottlieb reaffirmed the “importance of making sure women are appropriately represented in clinical trials.” He applauded the U.S. Food and Drug Administration’s (FDA’s) Office of Women’s Health (OWH) and its work in providing more than $40 million for 371 projects to “inform the FDA’s work about issues specific to women’s health and sex differences” at an agency event Wednesday (May 16) on “The Great Debate: What is Enough…Women in Clinical Trials?

There have been some encouraging results over the past several years, Gottlieb said. For example, an analysis by the OWH of enrollees in late-phase clinical trials supporting new molecular entity submissions found 52% were women in 2015, up from 39% in 2000.

Gottlieb also reported some of the findings of the FDA-led Decadal Review, a study that analyzed clinical trial safety and efficacy by sex across 34 drugs and five cardiovascular disease indications from 2005 to 2015. It also performed an exploratory analysis of the inclusion and criteria for five of the trials. The goal was to assess whether the criteria influenced patient enrollment.

“The study found minimal gender differences in drug efficacy and safety profiles,” Gottlieb said. It also found that women were well represented in trials of drugs for hypertension and atrial fibrillation, and overrepresented for pulmonary arterial hypertension. On the other end of the spectrum, women were underrepresented in trials studying therapies for heart failure, coronary artery disease, and acute coronary syndrome.

“In short, we still have more work to do,” Gottlieb said.

Gottlieb also issued a call to clinical investigators: “More work is needed to identify factors leading to under-participation of women in cardiovascular clinical trials in certain areas, notably heart failure, coronary artery disease, and acute coronary syndrome.”

FDA is trying to do its part. The agency launched a “Diverse Women in Clinical Trials Initiative,” which includes a consumer research campaign, as well as resources and workshops for health professionals and researchers. The agency is also organizing training webinars.

Author: Michael Causey