Data Suggests Yes, and that’s an Issue
Cancer drug clinical trials are severely lacking diversity in their groups of participants – specifically, African Americans, Asians, and Native Americans. Shockingly, this is even the case when the type of cancer affects these groups disproportionately.
In clinical trials for 24 of the 31 cancer drugs that have been approved since 2015, black participants made up less than 5% of the trial participant population. Even though African Americans make up just under a quarter of patients in the United States with multiple myeloma and are twice as likely as white people in the country to be diagnosed with it, they have made up just 4.5% of participants in studies for this type of cancer since 2003.
But African Americans aren’t the only group underrepresented.
In fact, most trials lack participation from other minorities; Asians, for example, have accounted for less than 2% of U.S.-based trials since 2015. In addition, Native Americans weren’t represented at all in more than two-thirds of trials. However, these groups (African Americans, Asians, and Native Americans) make up about 13%, 6%, and 1% of the U.S. population.
Drugs and Race: The Efficacy
Even though race is often considered more of a social concept, evidence suggesting that drugs may have different effects on people of different ethnicities is growing, whether for genetic or environmental reasons. For example, albuterol, a common asthma medication, is not as effective for Puerto Rican and African American children as it is for Mexican and European American kids. As for the multiple myeloma mentioned in the beginning of this article, the FDA has stated that “meaningful differences may exist in multiple myeloma disease biology, presentation, and response to treatment in blacks compared to whites.”
Causes of the Participation Gap
There are several reasons for minorities not participating in trials; they often don’t do so because of financial burdens, logistical challenges, and lingering distrust due to past victimization in medical experiments. In addition, they are more likely to have other health issues and die from certain diseases more often, such as heart disease, high blood pressure, and diabetes. Most trials have stringent trial inclusion criteria, so having multiple ailments excludes those patients from participation.
One of the most famous cases of the lingering distrust from prior victimization was seen in the Tuskegee Syphilis study, which began back in 1932. In this study, researchers intentionally withheld treatment from black men with syphilis in order to study the natural progression of the disease – without the consent of the participants. Another example was seen when thousands of Native American women were sterilized without their consent between 1973 and 1976.
The Benefits of Increased Minority Participation
While clinical trials are inherently risky, there are many benefits of having more minority participants take part in them:
- The U.S. population would be more accurately represented
- Disease biology would be better understood across various races
- Drug efficacy would be ensured across various populations
- Underserved communities would have better access to new, promising therapies
Are there any drawbacks to a higher minority participation rate?
Seeking more diverse patient populations while meeting strict enrollment criteria based on health conditions can be tricky. Increasing diversity may delay trials because it might take longer to find qualified participants to enroll. Increasing time often also means increasing money; obtaining more racially diverse populations may prove to be expensive. Companies would need to offset those costs by increasing prices or decreasing the number of drugs in research and development.
How Else Can We Increase Minority Participation in Clinical Trials?
While the FDA has recognized the lack of diversity in trials, it has yet to set any quotas or participation guidelines based on race. Gloria Sanchez-Contreras, spokeswoman for the FDA explains that “The FDA believes that enrollment should reflect the patients most likely to use a medical product, but the FDA does not have the regulatory authority to require specific levels of minority representation in clinical trials.”
Minority participation could be increased through government regulations; another option is to have pharma companies dedicate resources to educating trial leaders on how to diversify recruitment. Of the 31 clinical trials since 2015 that were previously mentioned, the two with the highest percentage of black participants were done by Johnson & Johnson – a company with an internal group on trial diversification.
Having appropriate pharma staff attend a clinical operations conference is one of the best ways to learn more about strategic planning, collaboration, and innovative technology to maximize the efficiency of clinical trials.
While drawbacks must be balanced with benefit of higher minority participation, it can take much effort, time, and money to establish regular racially balanced clinical trials, with money being the biggest challenge. However, when all is said and done, the increased short-term expenses may very well be vastly outweighed by the costs saved thanks to improved treatment and disease prevention altogether.