CLINICAL TRIALS
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when you look at clinical trials aimed at diseases disproportionately affecting minority communities. “African-American men are twice as likely as their white counterparts to die from prostate cancer. Yet they represent just 4% of prostate cancer clinical trial participants. Suicide is one of the top three causes of death among Asian-American women under 45 years of age; this cohort constitutes just 1% of trials for potential treatments for major depressive disorder. And while the prevalence of diabetes among Mexican-Americans and Puerto Ricans is more than double that of Caucasians, those groups combined represent just 4% of diabetes trial patients.”
With regards to gender, the above-mentioned 2013 NIH report showed percent enrollment by gender in all NIH clinical studies, excluding male and female only studies, to be split evenly at 49% each in FY2012. Yet, there are some areas where a clinical trial gender gap remains. The 2011 FDA report mentioned above stated that men make up more than two-thirds of the participants in clinical tests of cardiovascular (heart and blood vessel) devices. In addition, a recent editorial in the British Journal of Sports Medicine, for example, cites a study from 2014, where researchers reviewed nearly 1,400 sports and exercise research studies involving six million people over three years. Those researchers found that only 39% of those study participants, just slightly more than a third, were women. The scientists who authored this editorial claimed that researchers have been excluding women from sports and exercise research studies due to “complexities of the menstrual cycle” and the consequent potential interference of fluctuating female hormones.
Unfortunately, this kind of approach does not promote understanding of how real world hormonal fluctuations would affect trial outcomes.8
Consequences of the Minority and Gender Gap in Clinical Trials
This clinical trial diversity problem can have serious consequences, as effectiveness of a particular medication or medical device can vary depending on ethnicity and gender. Certain blood pressure drugs (beta blockers, angiotensive converting enzyme (ACE) inhibitors, and angiotensin II antagonists), for example, don’t work well for many African-Americans. If there are no African Americans in the clinical trials to approve these drugs, then these kind of efficacy exceptions will not be caught, and doctors won’t get the data they need to customize treatments for diseases disproportionately affecting minority populations. In addition, some studies have shown that women are twice as likely to suffer from adverse reactions to drugs, and 80 percent of drugs are withdrawn from the market due to unacceptable side effects in women.9
Increasing the participation of all minorities and women in clinical trials is critical for the production of knowledge about new therapies, because having diverse research participants can improve the generalizability of medicine. Additionally, minority participation in clinical trials is an important topic in public health discussions because this representation
pharmoutsourcing.com | 33 | November/December 2016
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