COMMENTARY

Why We Need Racial Diversity in Clinical Trials

Andrew M. Kaunitz, MD

Disclosures

June 14, 2016

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Hello. I'm Andrew Kaunitz, professor and associate chair of the Department of Obstetrics and Gynecology at the University of Florida College of Medicine in Jacksonville. Today I'd like to discuss the benefits of racial diversity in clinical trials.

As clinicians, we rely on trials to create evidence that we can use to help our patients make prudent therapeutic decisions. However, few who are eligible volunteer to participate in research studies. One reason for this is a low level of awareness or trust regarding how new therapies are developed. This lack of awareness and trust may be particularly prevalent among racial and ethnic minority populations, groups that are often underrepresented in clinical trials.

My colleague, Allison Bryant, and I reviewed a number of industry-funded clinical trials assessing new treatments for menopausal symptoms that were conducted over the past 15 years. We noted that minorities were substantially underrepresented in most studies and that none of the trials reported primary outcomes by race or ethnicity.[1]

In a recent issue of the journal Menopause, Pinkerton and her colleagues[2] compared the effect of conjugated estrogens combined with bazedoxifene on the treatment of menopausal symptoms and prevention of osteoporosis in white vs nonwhite women. Although the studies included in this report did not employ targeted recruitment of minorities, the pooled analysis allowed the investigators to assess the efficacy of this formulation in white and "minority" women, with "minority" referring to pooled black and Hispanic women. The authors found that the combination formulation's impact on symptoms and skeletal health was similar among white and minority women. Although combining black and Hispanic women into one group may have been necessary for this analysis to overcome relatively low numbers of minority participants, this approach is suboptimal because women of varying races and ethnicities experience the menopausal transition differently.

In contrast to the industry-sponsored trials we reviewed, two large, federally funded trials of midlife and menopausal women, the Study of Women's Health Across the Nation (SWAN) and the Women's Health Initiative (WHI), included clinical sites dedicated to recruiting minority women. The result was substantial minority participation in SWAN and WHI.

As clinicians, we need data about how new treatments affect not just white patients, but all of our patients. Likewise, regardless of background, women deserve information that allows them to predict how new therapies will perform in women like themselves. Pinkerton and her colleagues took a positive step forward in exploring the possibility of differential treatment effects by race and ethnicity. Future trials evaluating new therapies should strive to achieve racial and ethnic diversity to allow the evaluation of how therapeutic effects might be modified by race and ethnicity.

Thank you. I'm Andrew Kaunitz.

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