Chelsea Weidman Burke for Biospace writes (excerpted)

The lack of diversity (regarding clinical trials)  isn’t limited to African Americans – most clinical trials lacked participation from other minorities too. Although Asians are well represented in some foreign trials, they only accounted for less than 2 percent of the U.S.-based trials. Native American participants weren’t reported in nearly two-thirds of the trials. In contrast, African Americans, Asians and Native Americans make up about 13, 6 and 1 percent, respectively, of the U.S. population.

 

Although race is thought of as a social concept, ‘there’s growing evidence that, whether for environmental or genetic reasons, drugs may have different effects on different populations.’ One example is of the common asthma medication albuterol, which is less effective in African American and Puerto Rican children compared with European American and Mexican children. In an analysis of the demographics of multiple myeloma clinical trials, scientists at the Food and Drug Administration (FDA) wrote that “meaningful differences may exist in multiple myeloma disease biology, presentation, and response to treatment in blacks compared to whites.”

 

Increasing Trial Diversity

One way to increase minority enrollment could be through government regulations. Some people believe that biopharma companies aren’t likely to focus on minority recruitment unless the government pressures them to do so.

 

In 2015, the FDA started publishing “Drug Trials Snapshots” detailing the demographics of clinical trials for newly approved drugs. The FDA has called out the lack of diversity but hasn’t set quotas or guidelines for participation based on race.

 

“The FDA believes that enrollment should reflect the patients most likely to use a medical product,” spokeswoman Gloria Sanchez-Contreras told ProPublica. The FDA “does not have the regulatory authority to require specific levels of minority representation in clinical trials,” but encourages diversity.

 

Another option may involve biopharma companies dedicating resources to educate clinical trial leaders on how to diversify recruitment. Of the 31 cancer drug trials that ProPublica examined, the two with the highest black participation – the multiple myeloma drug Darzalex and the soft tissue cancer drug Yondelis – were both made by Johnson & Johnson, who has an internal group on trial diversification. The group also encouraged minority physicians to run the trials because some patients prefer being treated by doctors of their own race or gender.

 

An impactful way of improving diversity may be through patient education and rebuilding minority’s trust in medical research. Increasing communications between doctors and patients and informing patients of the option to participate in trials early in their diagnosis will be key.

 

Biopharma companies also continue to track drugs for racial differences post-approval, even running new studies with higher proportions of minorities. Johnson & Johnson even found that the prostate cancer drug Zytiga worked better in black men than white men in a post-market study. The FDA also uses a surveillance system to study approved drugs and examine a drug’s efficacy in specific populations.

 

While minority participation based on race has room for improvement, trial diversity is moving in the right direction by including women and children more frequently than 20 years ago.

 

(this is an excerpt, to read the complete article by Chelsea Weidman Burke visit Biospace by clicking here.)