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1. An FDA ten year review of clinical trials for approved Obstetrics and Gynecological medical devices Dipali Dave, MD1, Jill Brown, MD, MPH2, Beverly Gallauresi, RN, MPH1 1Office of Women’s Health, 2 Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, MD ABSTRACT RESULTS RESULTS Device Trial Demographics From Year to Year Objectives: Prevalence, progression of disease and health outcomes differ by sex and race/ethnicity. To accurately assess racial/ethnic differences in safety and efficacy of medical devices, sufficient representation of all racial/ethnic groups within clinical trials is recommended. The purpose of this study was to review the participation of females of varying race/ethnic groups in Obstetrics/Gynecological Premarket Application (PMA) pivotal clinical device trials. Methods: All Obstetrics/Gynecological clinical device trials submitted to the FDA in support of PMAs approved from January 2001 to December 2010 were reviewed. Descriptive analyses of demographic features of study participants were conducted using criteria from the US FDA Guidance Document entitled “Collection of Race and Ethnicity Data in Clinical Trials.” A total of 16 Obstetrics/Gynecological PMAs were reviewed, and data were analyzed in 12 month intervals Results: Of the 16 PMA submissions, 10 included race/ethnicity data. The average racial/ethnic participation over the 10-year period was: White (74.4%), Black/African American (11%), Hispanic or Latino (9.4%), Asian (1%), Native Hawaiian or Other Pacific Islander (0%), American Indian/Alaskan Native (0.1%), and Other (2.7%). White women represented the majority of participants across all years. Asian, Native Pacific Islander, and American Indian/Alaskan Native women consistently constituted less than 2% of study participants. No trends could be determined for Black/African American and Hispanic/Latino participants. Conclusions: This 10 year review indicates that representation in Obstetrics/Gynecological clinical device trials is predominantly white females. An increase in the proportions of participants from less represented racial/ethnic groups would allow for better outcome analyses in these populations. Participation Percentage Year MATERIALS AND METHODS • All Obstetrics/Gynecological clincal device trials submitted to the FDA in support of PMAs approved from January 2001 to December 2010 were reviewed. • Descriptive analyses of demographic features of study participants were conducted using criteria from the FDA Guidance Document entitled “Collection of Race and Ethnicity Data in Clinical Trials1.” • A total of 16 Obstetrics/Gynecological PMA studies were reviewed, and data were analyzed in 12 month intervals. • Year 2005 had one PMA submission, but no demographic data were included. • Year 2007, 2008, and 2010 had no PMA submissions. Race CONCLUSIONS • This 10 year review indicates that representation in Obstetrics/Gynecological clinical trail devices is predominantly white females (74.4%). • An increase in the proportions of participants from less represented racial/ethnic groups would allow for better outcome analyses. Comparison of Device Trial Demographics to Current US Population Demographics RESULTS • Of the 16 PMA submissions, 10 included race/ethnicity data. • The average racial/ethnic participation over the 10-year period was: • White (74.4%), • Black/African American (11%), • Hispanic or Latino (9.4%), • Asian (1%), • Native Hawaiian or Other Pacific Islander (0%), • American Indian/Alaskan Native (0.1%), and • Other (2.7%). • White women represented the majority of participants across all years. • Asian, Native Pacific Islander, and American Indian/Alaskan Native women consistently constituted less than 2% of study participants. • No trends could be determined for Black/African American and Hispanic/Latino participants. Participation Percentage REFERENCE Guidance for Industry (2005) Collection of Race and Ethnicity Data in Clinical Trials. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126396.pdf