February 17, 2016

February Is a Time for Celebrating Black History, Heart Health…and Clinical Trials?

By Andrea L. Lowe, MPH, SWHR Health Policy and Public Health Liaison

February is both Black History Month and American Heart Month. In support of both events, the Society for Women’s Health Research (SWHR®) would like to take the time to encourage African American women to take charge of their health and participate in clinical research opportunities designed to reduce their likelihood of heart disease over the course of their lifetime.

Black women have the highest percentage of hypertension and second highest percentage of experiencing any type of heart disease out of all races/ethnicities and both genders [1]. In 2012, the U.S. Centers for Disease Control and Prevention (CDC) reported that 11.1 percent of adult Black women have some form of heart disease; the majority of whom (35.4 percent) had hypertension or high blood pressure, 6.3 percent had coronary heart disease, and 3.3 percent have experienced a stroke [1].

Despite this, Black women (as well as other minorities and women in general) have traditionally been vastly underrepresented in clinical trials studying the safety and efficacy of cardiovascular disease drugs. A 2002 study examining the representation of the elderly, women in general, and minorities in heart failure clinical trials found that only four of the 59 trials studied included at least 25 percent minority participation and only two trials included at least 50 percent female participation [2].

In addition to limited recruitment of Black women in clinical trials, researchers have found that a history of medical abuse of minority populations in the U.S. contributes to lower participation rates. Historically, Black men and women have often been exploited for medical knowledge, such as use for dissection and medical demonstration during slavery as well as more recently with the Tuskegee Syphilis Study that continued into the 1970s, which denied participants treatment after medication was available to cure the disease [3].

But these injustices are not the only reason for low participation rates in clinical trials. Researchers from the University of Illinois at Chicago found four major barriers to participation: 1) lack of awareness, 2) economic factors, 3) communication issues, and 4) mistrust [3]. While survey participants in this study were afraid of being treated as “guinea pigs,” the researchers also found that only 5.4 percent had ever participated in a clinical trial and only 15.8 percent were ever even asked to participate. Meanwhile, 68 percent of the respondents indicated that they would consider participating if asked [3].

In response to the increased need for diverse women to participate in medical research, the U.S. Food and Drug Administration (FDA) recently launched its Women in Clinical Trials initiative. The website includes a Frequently Asked Questions (FAQs) section, “15 Things to Know,” and the opportunity to find clinical trials currently recruiting participants in your area [4]. Every woman considering joining a clinical trial should know its purpose and what is expected to happen during the study, the possible risks and benefits, additional support (such as child care or transportation) and costs, as well as how to find out more information before making the decision to participate [4].

Amid the many events and celebrations for Black History Month and American Heart Month, take time to consider your health and contribute to future advancement in treatments for minorities by participating in a clinical trial. More information on SWHR’s long history of supporting clinical trial participation by women and minorities can be found on our website.

1. National Center for Health Statistics. Summary Health Statistics for U.S. Adults: National Health Interview Survey, 2012. U.S. Centers for Disease Control and Prevention, 2014. Web. 29 Jan 2016. <http://www.cdc.gov/nchs/data/series/sr_10/sr10_260.pdf>.

Heiat, Asefah et al. “Representation of the Elderly, Women, and Minorities in Heart Failure Clinical Trials.” Arch Intern Med. 162(15) (2002). Web. 29 Jan 2016. <http://archinte.jamanetwork.com/article.aspx?articleid=1148796>.

3. Harris, Yvonne et al. “Why African Americans May Not Be Participating in Clinical Trials.” J Natl Med Assoc. 88 (1996): 630-4. Print.

4. n.p. Women in Clinical Trials. U.S. Food and Drug Administration, 2016. Web. 29 Jan 2016. <http://www.fda.gov/ForConsumers/ByAudience/ForWomen/ucm118508.htm>.