METHODS

1. A review of recently approved cardiovascular medical devices: Are women and ethnic minorities adequately represented? Beverly Gallauresi, Keshav Khanijow, Sphoorti Umarjee, Ameeta Parekh- Food and Drug Administration, Rockville, MD METHODS RESULTS (CONT’D) ABSTRACT • Background: Different demographic subgroups may have differences in the prevalence, progression, health outcomes, treatments, and diagnostics of some diseases. Although cardiovascular disease (CVD) is the number one killer of women, women have historically been underrepresented in cardiovascular clinical trials (CVTs). To accurately assess sex differences in the safety and efficacy of medical devices, it is necessary to have adequate representation of both sexes in clinical trials. The purpose of this study was to review premarket applications (PMAs) for CVTs and assess their participation of women and ethnic minorities. • Methods: All cardiovascular clinical trials (CVTs) submitted to the FDA in support of PMAs approved from 01/2005-12/2009 were reviewed. Descriptive analyses of each study’s participants’ ethnicity and sex were tabulated. Demographic data from PMAs were analyzed in 12 month intervals to detect any notable trends in the rate of women’s participation. • Results: 44 cardiovascular PMAs were approved between 01/2005 and 12/2009. 1 PMA was excluded from review as the clinical trial addressed a pediatric population. 8 PMAs included ethnicity data with the following average participation rates: Caucasian (85.5%), Black (9.6%), Hispanic (1.8%), Asian (2.3%), Other (1.4%). Women’s participation in PMA CVTs was 36.5% in 2005, 26.9% in 2006, 39.5% in 2007, 34.4% in 2008, and 32.0% in 2009. The average women’s percentage of participation in PMAs for this 5-year period was 33.9% (± 4.8%). • Conclusions:This five year review indicates that there is no recognizable trend of women’s participation in CVTs, and that there is a need to increase reporting of data by ethnicity. More advocacy is needed to increase the proportion of ethnic minorities participating in clinical trials. • A list of PMAs with cardiovascular device indications was tabulated from the CDRH Applications online resource. Studies that addressed pediatric indications were excluded. The demographic data were analyzed in five 12-month segments to observe trends in the participation rate of women. In addition, the overall participation of racial minorities was calculated. • For PMA’s that contained multiple studies, the percentage of women or ethnicities enrolled within each of those PMA studies were averaged. Only studies within the PMA’s that had relevant sex or ethnicity information were used to obtain the percent participation rates. • There is no continuous increase or decrease in the average participation of women in PMA CVTs from 2005 to 2009 RESULTS • 44 PMAs with cardiovascular device indications were approved from 2005-2009 • 1 PMA was excluded from analysis as it addressed a pediatric population. • All PMAs reported their subjects demographics by sex • 8 PMAs reported ethnicity data for their subjects INTRODUCTION Demographic subgroups have different disease outcomes and they also respond to treatments differently . Cardiovascular disease is currently the number one killer of women in the United States2, and African-Americans are more likely to die from heart disease that their non-Hispanic White counterparts3. To better assess these potentially differing outcomes, it is important that women and racial minorities are adequately represented in clinical trials In part due to the fear of a repeat of the Thalidomide birth defect epidemic of the 1960’s, women have historically been underrepresented or excluded from clinical trials. As a result, there has been a knowledge gap in the understanding of sex differences in disease presentation, prevalence, diagnoses, and treatment outcomes. Nevertheless, since 1988, the US FDA has made a conscious effort towards adequate representation of demographic subgroups in all clinical trials through guidances and regulations that promote women’s and ethnic minorities’ participation in all phases of clinical studies and the analysis of data related to sex. The Office of Women's Health (OWH) at the FDA was established in 1994. The OWH’s mission is to (1) advocate for inclusion of women in clinical trials and analysis of sex/gender effects, and (2) protect and advance the health of women through policy, science, and outreach. Since its inception, the OWH has invested a considerable effort towards the understanding of cardiovascular disease in women through the support of several research studies. The purpose of this study was to review the participation of women and ethnic minorities in clinical trials for new cardiovascular devices approved from 01/2005 to 12/2009. In the medical device review process, device manufacturers submit a Premarket Application (PMA) to the Center of Devices and Radiologic Health (CDRH) within the FDA. Each PMA includes data from clinical trials that are used to support and prove the efficacy and safety of the medical device. If the PMA contains adequate valid scientific evidence to provide a reasonable assurance that thee device is safe and effective, when used in accordance with the labeling on the patient population identified in that labeling, then the PMA can be approved. 1 • Caucasians were enrolled in a higher percentage than other ethnicities CONCLUSION • There was no significant increase or decrease in the average participation of women by year from 2005 to 2009. • Demographic data reporting by sex was present in all PMAs reviewed. However, only 19% of PMAs reported demographic data by ethnicity. Additional efforts are needed to encourage the reporting of data by ethnicity. • Caucasians made up a majority of subjects for whom race was reported. Additional efforts are also needed for the recruitment of ethnic minorities in cardiovascular device clinical trials. REFERENCES • Merkatz, Ruth B. "Inclusion of Women in Clinical Trials: A Historical Overview of Scientific, Ethical, and Legal Issues." Journal of Obstetric, Gynecologic and Neonatal Nursing 27.1 (1998): 78-84. • "Women and Cardiovascular Disease." American Heart Association. Web. 28 July 2010. <http://www.americanheart.org/presenter.jhtml?identifier=1200011>. • "Heart Disease and African Americans - The Office of Minority Health." The Office of Minority Health. Web. 20 July 2010. <http://minorityhealth.hhs.gov/templates/content.aspx?ID=3018> • The percentage of women participating in each PMA varied