Sex and Ethnicity Data Missing From Many FDA Medical Device Approval Reports Interview with:

Sanket Dhruva, MD, MHS, FACC Cardiology, VA Connecticut Healthcare System Robert Wood Johnson Foundation Clinical Scholar Yale University

Dr. Dhruva

Sanket Dhruva, MD, MHS, FACC
Cardiology, VA Connecticut Healthcare System
Robert Wood Johnson Foundation Clinical Scholar
Yale University What is the background for this study? What are the main findings?

Response: In 2012, Congress passed the Food & Drug Administration (FDA) Safety and Innovation Act, with the goal of increasing enrollment and availability of data in important patient groups such as the elderly, women, and racial and ethnic minorities. In 2014, as mandated by the legislation, the FDA released an Action Plan to address these issues. This Action Plan included the goal of increasing the transparency by posting demographic information of pivotal (or key) clinical trials used to support approval decisions.

We examined how often these data were available in 2015 for all studies used to support approval of all original high-risk medical devices approved in the calendar year following the FDA Action Plan. Examples of these medical devices include stents, bone grafts, heart valves, and spinal cord stimulators. We wanted to understand if age, sex, and race and ethnicity data were available and if the results of clinical studies supporting these medical devices were analyzed to assess if there were differences in safety and effectiveness by these important demographic factors.

Our main findings are that FDA Summaries publicly reported age for 65% of study populations, sex for 66%, and race and/or ethnicity for 51%. Analyses to assess if demographic factors may have impacted device safety and effectiveness were only conducted by age for 9%, by sex for 17%, and by race for 4% of clinical studies. What should clinicians and patients take away from your report?

Response: There are important — and necessary — opportunities to improve the transparency and reporting of demographic-specific information and analyses for the highest-risk medical devices at the time of FDA approval. What recommendations do you have for future research as a result of this study?

Response: Because analyses to assess if demographic factors impacted device safety and effectiveness were rarely conducted prior to FDA approval, there is an important need to study how these medical devices perform in diverse patient populations in the post-market setting.  

I have no disclosures relevant to this work. Thank you for your contribution to the community.


Dhruva SS, Mazure CM, Ross JS, Redberg RF. Inclusion of Demographic-Specific Information in Studies Supporting US Food & Drug Administration Approval of High-Risk Medical Devices. JAMA Intern Med. Published online July 24, 2017. doi:10.1001/jamainternmed.2017.3148

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Last Updated on July 25, 2017 by Marie Benz MD FAAD