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Why Racial Diversity in Clinical Trials Matters

Clinical trials provide a critical base of evidence for evaluating whether a medical product is effective before the product is approved for marketing. One challenge that remains is ensuring that research participants are representative of the patients who will use the medical product.In 2014, the Federal Drug Administration (FDA) released a report that called for, among other things, “identifying barriers to subgroup enrollment in clinical trials and employing strategies to encourage greater participation,” that was specifically aimed at underrepresented ethnic populations and women. Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials. In response to these concerns, Congress included Section 907 in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, giving FDA direction to evaluate this issue and take action.An infographic published by Continuum Clinical shows examples of the massive health disparities among common disease states across different races and genders.
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According to the FDA, African Americans comprise 14% of the U.S. population, but only 5% of clinical trial participants. As the infographic above illustrates, African Americans account for a disproportionately high number of cases of cardiovascular disease and hypertension. Similarly, Hispanic/Latinos comprise 17% of the U.S. population, but less than 1% of clinical trial participants. Yet diseases such as obesity and Type 2 diabetes disproportionately affect Hispanic populations.Racial diversity in clinical studies matters because patients may respond differently to therapies based on their ethnicity or gender.For example, studies for a recently approved schizophrenia drug found that two important classes of blood pressure drugs were found to work less well in black/African American patients. The FDA has also reported labeling changes due to differences in dosing requirements between men and women, such as the recent labeling change with a sleep medication. As the  FDA’s Commissioner of Food and Drugs, Robert Cliff, stated in early 2016 when the FDA declared 2016 as the year of diversity in clinical trials, “These few examples show the importance of improving diversity in clinical trials, so medical products are safe and effective for everyone.”Welocalize Life Sciences specializes in linguistically and culturally accurate translation services for life sciences companies. Contact us for more information about our services for highly regulated industries.