CLINICAL TRIALS


Barriers to Increased Participation of Minorities in Clinical Trials


Sujay Jadhav CEO


goBalto


Clinical trials are at the heart of the process for bringing new medicines to patients. One of the most critical aspects to the conduct of any clinical trial is identifying the right group of people to include in the study. Unfortunately, many of the clinical trials conducted in the United States suffer from a lack of diversity, with minority populations being consistently underrepresented. In addition, there is often a lack of consideration of cultural and genetic factors which are particular to Asian, African-American, Hispanic, and other minorities that may influence results. This ethnic diversity gap can lead to less than ideal development of new medicines and can further exacerbate minority health issues.


In 2015, a study published in the journal of PLoS Medicine1 concluded


that biomedical research often does not reflect the American population. Sam Oh, an epidemiologist at the University of California, San Francisco Center for Genes, Environment and Health and researcher on the study recounts an example uncovered in the research. In a recent interview,2


The Minority and Gender Gap in Clinical Trials


The National Institute of Health (NIH) Revitalization Act of 1993, passed by Congress and signed into law by President Bill Clinton, required that all NIH-funded medical research include women and minorities. Even though this act was passed 23 years ago, both gender and minority disparities remain in clinical trial participant populations.


Minority groups include American Indian or Alaskan Native, Asian, Native Hawaiian or Pacific Islander, African American, and Hispanic. US 2015 census data shows that minorities currently make up around 40% of the US population.4


A 2013 NIH report, however, indicates that Oh states that "African-Americans and Puerto Ricans


don't respond as well to some of the most common asthma controller medications, and that's really a tragedy since these two groups are the most affected by asthma in the United States." Coming across disparities like the asthma example, Oh says, "you begin to wonder, 'Well, why is this the case?' And part of that reason might be because our biomedical studies in the past have not recruited as heavily in those populations." Such findings are common across many therapeutic areas. For example, the study reports that, "Only 2% of cancer studies and less than 5% of pulmonary studies have studied enough minorities to provide use- ful information."


In response to this issue, the Food & Drug Administration recently launched the first phase of a campaign to encourage minorities to participate in clinical trials. In a recent blog post, Jonca Bull, FDA’s Assistant Commissioner for Minority Health, Office of Minority Health, called for minorities to be “clinical trial champions,” and explained why it is critical to for the agency to encourage minority participation: “Clinical trials participants need to more closely mirror the patients who will ultimately use the medicine,” Bull writes. “This is especially important when considering health disparities - diseases that occur more frequently or appear differently in non-white populations. But most clinical trials participants are white and male... If we do not develop a more diverse pool of research participants, health disparities may persist because we will not know if a medical product is safe and effective in the actual population that will ultimately use it.”3


minorities only represent around 30% of those enrolled in domestic NIH clinical research. Broken down into individual minority groups, it is clear that there is still work to do in order to have clinical trials more closely match the population at large, particularly with regard to the Hispanic population.5


While the NIH appears to have made some progress in the inclusion of minorities in clinical trials, the picture outside the NIH is more bleak. One report found that Hispanic representation in industry-sponsored clinical trials may be as low as 3%.6


the conference "Dialogues on Diversifying Clinical Trials," sponsored by FDA’s Office of Women’ s Health and the Society for Women’s Health Research and supported by the Office of Minority Health (OMH):


• African Americans represent 12% of the U.S. population but only 5% of clinical trial participants


• Hispanics make up 16% of the population but only 1% of clinical trial participants7


According to John Lechleiter, Chairman, President and Chief Executive Officer of Eli Lilly and Company, the ethnic diversity gap is even worse


Table 1.


Minority Group


Hispanics


US Census Data (%)


17.6


African Americans 13.3 Asians


5.6


American Indians 1.2 Pacific Islander


0.2 Pharmaceutical Outsourcing | 32 | November/December 2016


% enrollment in domestic NIH clinical research (FY2012)


8.4


11.1 6.9 0.8 0.4


In addition, according to a 2011 report from


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