Results

1. An FDA ten year review of clinical trials for approved medical devices for women 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 INTRODUCTION Results RESULTS Prevalence, progression of disease and health outcomes differ by sex and race/ethnicity. Efficacy and safety differences have been well documented for drugs but not for devices. The US FDA Guidance document “Collection of Race and Ethnicity Data in Clinical Trials1” encourages clinical device trials to include demographic data to determine any racial/ethnic differences in safety and efficacy. Safety and efficacy analyses of any new medical treatment or surgical intervention should always include subpopulation analyses by race and ethnicity2. The future of medicine is rapidly moving to “personalized medicine” therefore its is imperative that clinical trial data include racial/ethnic data to target medical devices and medication to those who will be needing them most. In cases in which there are important racial/ethnic differences in causes of disease or other outcomes or in which there are interactions between race/ethnic background and other factors contributing to these outcomes, such patterns would never be discovered, their causes could not be identified, and the appropriate interventions would never be applied to in the groups which they were needed3. 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. Device Trial Demographics From Year to Year Participation Percentage Year Race MATERIALS AND 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. • Year 2005 had one PMA submission, but no demographic data include. • Year 2007, 2008, and 2010 had no PMA submissions. Comparison of Device Trial Demographics to Current US Population Demographics CONCLUSIONS • The representation of different racial/ethnic groups in Obstetrics/Gynecological clinical device trials only reflects the current demographics of the United States population for Whites and Black/African American, but not for other racial/ethnic groups such as Asians and Hispanics. • To do clinically meaningful analysis by race, efforts should be made to diversify the recruitment and retention of patients for device trials. RESULTS Participation Percentage • 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. REFERENCES Guidance for Industry (2005) Collection of Race and Ethnicity Data in Clinical Trials. http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126396.pdf 2. The Endocrine Society, Increasing Minority Participation in Clinical Research, December 2007 http://www.hormone.org/Public/clinical_trials_content/loader.cfm?csModule=security/getfile&pageid=1131 3. Burchard, E; Ziv, E; Coyle, N; Gomez, S; Tang, H; Karter, A; Mountain, J; Perez-Stable, E; Sheppard, D; Risch, N. The Importance of Race and Ethnic Background in Biomedical Research and Clinical Practice New England Journal of Medicine 348(12), 1170-1175 (2003).