First of two parts
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 Research, 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.
The sites represent 50 investigators collaborating on trials in multiple therapeutic areas. Sites are located in Florida, Georgia, Nebraska, Tennessee and Texas; they are minority-owned, have a minority principal investigator or oversee a large database of minority subjects.
Historically, minorities have been underserved 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.
Next month: More on the CDCR’s mission.
Written by Guest Writer Melissa Poindexter. Poindexter, R.N., B.S.N., is president of Advances in Health (AIH), an independent clinical research center in Houston that specializes in women’s health. AIH has collaborated in phase I-IV trials since 1998. She is a member of the Consortium for Diversity in Clinical Research (CDCR), ACRP, DIA and SCRS.
This article was reprinted from Volume 22, Issue 10, of The CenterWatch Monthly, an industry leading publication providing hard-hitting, authoritative business and financial coverage of the clinical research space. The Action Items section features short columns focusing on actionable or how-to advice from clinical trial professionals. To submit an Action Item, please contact firstname.lastname@example.org. Subscribe >>