The CenterWatch Monthly

Group seeks greater diversity in clinical research…

In 2006, a trial led to a “black box warning label” for an asthma medication found to have a disproportionally increased death rate. It revealed that respiratory-related deaths occurred four times more often in African-Americans who took the drug.

In 2007, additional studies showed that long-acting beta-antagonist drugs worsen asthma due to down-regulation of b-adrenergic system as a result of the stimulation of b-receptors. This genotype affects roughly one-sixth of U.S. citizens and may be more prevalent in specific minorities, including African-Americans.

These studies are a classic example of why it is important all subgroups be appropriately represented in research.
Ensuring meaningful representation of minorities in trials is a primary goal of the Consortium for Diversity in Clinical Re- search, which was organized in 2011. CDCR is a group of experienced sites, with a vested interest in increasing diversity in all aspects of clinical research trials, including Principal Investigators and subjects.
Historically, minorities have been under- served in clinical trials. Hispanics represent
16% of the population but only 1% of U.S. clinical trial participants; African-Americans represent 12% of the population but only
5% of participants.
The FDA Safety and Innovation Act passed by Congress in 2012 supports efforts to enhance diversity of subgroups (sex, age, race and ethnicity).

There is greater assurance in the safety and effectiveness of investigational products when there is subgroup data to analyze.

Diversity at CDCR sites promotes representation of behavioral, cultural and genetic differences—therefore ensuring drugs are effective and safe for minority populations.
Over the past 20 years, the combined efforts of Congress, along with the offices of women’s health at FDA and NIH, have increased the participation of women in clinical trials. Minorities, however, still account for less than 5% of clinical trial participants. In fact, minorities “are not hard to reach; they are hardly reached” (Lu Chen, HealthDay News, March 2014).
The lack of trust with doctors and health officials that developed from the Tuskegee Syphilis Study still lingers. Not surprisingly, minority patients are more likely to choose physicians of their own race or ethnicity. In addition, minorities of low socioeconomic sta- tus have transportation, babysitting and job is- sues, making compliance with frequent study visits more challenging. Taking time off puts them at risk for losing their jobs. Offering flexible hours and advocating for higher stipends (within GCP guidelines) helps participants work around socioeconomic issues.
The Consortium of Diversity in Clinical Research (CDCR) is making a difference by developing awareness and trust, mentoring minority physicians and recruiting minority subjects.

CDCR sites such as Chattanoo- ga Medical Research (CMR) in Tennessee, Advances in Health (AIH) in Houston and AGA Clinical Trials in Miami are increasing diversity through education and awareness development. CMR has partnered with local high schools and colleges to educate students not only about clinical research, but also ca- reer paths within the industry. AIH holds seminars with the Black Nurses Association and participates in community outreach ministries within minority neighborhoods. AGA is active with the American Diabetes Association and participates in local health fairs and events.

Three other CDCR sites—Atlanta Premier and Research 1, both in Atlanta, along with Quality Clinical Research in Omaha, Neb.— are recruiting and mentoring minority physi- cians as PIs in their networks. The consortium is attempting to make a difference in increasing diversity representation in clinical trials.