FDA Report: Have You Considered Patient Diversity in Clinical Trials?

In August of 2013, the FDA released a report that analyzed clinical trial subject demographic subgroups for FDA approved medical products, which included factors such as race, age and gender.  After reviewing the report in detail, I started thinking about the importance of incorporating diversity into clinical trials.

What Did the Report Find?

This report analyzed data from several biopharmaceutical and medical device clinical trials, and the report emphasized several observations. The FDA mentioned that gender was represented appropriately in clinical trials, however, every trial contained different distributions based on disease indication.  To demonstrate, systemic lupus erythematosus trials consisted of over 90% females, whereas HIV trials consisted of approximately 75% males.

Alternatively, the report indicated that racial underrepresentation was prominent, as many clinical trial participants were predominantly White and excluded minorities, such as African Americans and Asians.  For instance, Hep C trial racial composition were as follows: 83% White, 14% African-American, 2% Asian, and 2% Other.

Why is Diversity in Clinical Trials Important?

According to the FDA report, “one of FDA's goals is to make regulatory decisions based on scientific information and to publicly communicate actionable information.  That is, when clinically meaningful differences are observed for certain subgroups (e.g., an adverse effect seen more commonly with a certain genetic mutation), this information is included in the product labeling or otherwise publicly released.”

Incorporating diversity in clinical trials is important because a medical product may have a different effect on various patient populations. Essentially, socioeconomics and genetics may play significant roles in how an obese patient of a specific race would react to a medical product compared to a skinny patient of another race.  Ultimately, it is the FDA’s objective to appropriately communicate medical outcomes through precise product labeling in order to guide physician decision-making.

What Can My Team Do to Enhance Racial Diversity in Clinical Trials?

• Incorporate Diversity in the Subject Enrollment Plan

The first step is to develop a subject enrollment plan that describes and depicts strategies and methods on how clinical teams are to tackle enrollment challenges.  This plan should also include identifying and targeting diverse patient populations.

• Understand the Patient

If the study team is going to access a specific patient population, they need to understand not only behavioral characteristics of the specific population, but also overcome cultural and language barriers.

• Access expertise on campaign execution

In our experience, we have been able to target specific patient populations by executing highly targeted campaigns that speak directly to the patient. For example, in a Hep B trial, we identified that Asian and Haitian populations were at risk of carrying Hep B, and also felt hesitant against talking about medical conditions.  We implemented campaigns at Karate Lesson houses to target Asian populations and partnered with a Haitian radio star to raise awareness about Hep B amongst the Haitian community to drive patients to study sites.  To our expectation, the Sponsor observed a significant uptick in Asian and Haitian population screening efforts and subsequent enrollment.

By Moe Alsumidaie, VP Analytics & Clinical Affairs, DNA Clinical Communications.  Moe Alsumidaie can be reached here. If you are interested in joining the discussion, apply to the Breakthrough Solutions in Clinical Trials & Healthcare Group