The Lack of Diversity in Clinical Research - Its Racism

 We have a problem. We allow our research and clinical trials not to mirror our diverse population, compromising our medical research and our interventions' safety and efficacy. 

Not having diversity in our research populations means that we do not understand and reflect our population's actual biological heterogeneity. Not acknowledging the heterogeneity compromises our clinical research and, thus, our treatment efficacy and safety.  

Our clinical research lacks diversity, which speaks to a fundamental under-lying injustice that our society needs to face and reverse. Not making sure that we have a wide range of diverse populations participating in our clinical research is unsafe and unfair.

Excluding diverse populations, whether intentionally or by our lack of effort, from our clinical studies means that we miss learning about and understanding our world's rich biological heterogeneity. We compromise our ability to understand real-life treatment efficacy and side effects. It prevents us from understanding how diverse populations will be affected by our treatments. 

Despite this, we continue to fail in the task of accruing diverse populations in our clinical studies. If we continue to fail to attract and accrue diverse populations into our clinical studies, we fail the science and fail our essential ethical duty.  

We need to decide to do better. We need to be deliberate in our efforts to ensure that all of our clinical studies include diverse populations. Diverse populations who take an active role in our clinical studies should consist of people of different genders, sexual preferences, ethnic backgrounds, and racial groups. 

The true extent of our problem came into focus when the FDA published the Drug Trial Snapshot. The snapshot showed that during 2015 and 2016, there were 67 new FDA approvals, but only 3 percent of the study participants in the clinical studies leading to these approvals were African-American. (1)    

There have been many other scientific literature reports and the public press pointing out that we suffer from a lack of diversity in our clinical study populations. The lack of diversity includes the lack of diversity in race, ethnicity, sexual preference, gender, the elderly, the young, urban vs. rural, and non-demographic variables such as comorbidities. 

The most current FDA SnapShot (2019) showed little improvement, especially in the oncology sector. According to the report, "A total of 3,593 patients participated in the trials that led to the approvals of 11 new drugs. Overall, 38% of all participants were women, 73% were White, 18% were Asian, 4% were Black or African American, 5% were Hispanic, 59% were 65 years and older, and 24% were from sites in the United States".  (2)  

Despite the hard work that has been put into resolving our diversity problem, we are still far from fixing this problem. We need to conquer this problem; it is only by ensuring all of our diverse populations participate in our clinical research to meet our obligation to protect public health.  

The COVID-19 pandemic has removed the scab and pointed out our failure to include diverse populations in our clinical research. 

 COVID has emphasized the significant inequities in health outcomes for our diverse populations. Black, Latin, Pacific Islander populations and the more vulnerable people like the homeless, incarcerated, aged, and institutionalized populations have suffered more with COVID-19.  

COVID has disproportionately affected these populations. These populations have suffered greater severity of illness and mortality from the virus. Often blamed are issues like these populations suffer from many more comorbidities. They lack access to testing and healthcare delivery, live in denser quarters, are more dependent on public transportation, and potentially have genetic differences that make them more susceptible. Without the research to back these statements, how do we know if any of these statements are true? Without the research, how do we know what are the relative contributions, if at all, of these underlying factors?  

The global pandemic can be thought of as another example of systemic racism in the United States. The deaths of George Floyd, Ahmaud Arbery, Breonna Taylor, and countless others before them decry our racism. Our failure to have equal access to clinical research participation and healthcare access speaks negatively about us as a people. 

 Can we turn this one lesson of the pandemic into a call to action? Eliminating racism and racial inequalities can begin with insisting on having equity in healthcare. This process starts with a deliberate decision to make sure that we always make sure that we include all of our diverse populations in our health research. Perhaps, making sure that we are more inclusive in our clinical studies will be the first but essential step to guaranteeing equitable healthcare access and outcomes for all people. 

 (1) (U.S. Food and Drug Administration. 2015-2016 Drug Trials Snapshots Summary Report. Available at https://www.fda.gov/media/103160/download  and U.S. Food and Drug Administration. 2015-2016 Global Participation in Clinical Trials Report. Available at https://www.fda.gov/media/106725/download

(2)(U.S. Food and Drug Administration. 2019 Drug Trials Snapshot Summary 

Available at https://www.fda.gov/media/135337/download