Why is minority inclusion in clinical trials necessary?

At MplusM Consulting we pride ourselves in being a network of clinical research centers focused largely on the hispanic and minority markets. We aim to increase the participation of minorities in clinical trials by working with minority physicians who can connect culturally and linguistlically to those hard to reach populations. However, we are concerned that not enough effort is put into making sure that these populations are always included in clinical trials. So, we want to offer a compelling argument of why it is so important to always include minorities in clinical trials.

People of different races and ethnicities may react differently to medical products. This, in and of itself, should suffice to make the inclusion of racially and ethnically diverse populations a must in all clinical trials, we need to make sure that the medical treatments we try today will work well for the global population of the future. We are increasingly becoming a more diverse society and we need to guarantee that the treatments we develop can address our ailments as a whole, not only for a portion of us.

“As more research reveals that genetics affect disease susceptibility and drug efficacy, researchers are looking for ways to get more minori­ties involved in drug and medical research.”

Without appropriate inclusion in clinical trials, health disparities among racial/ethnic minorities are very likely to widen even more. It is difficult to envision a clearer example of the disparity that exists between racially diverse populations in the United States than the current COVID-19 pandemic. The New York Times reported that out of 100,000 deaths, 10.2 were white individuals 19.8 were black individuals, and a staggering 22.8 were Latino. Not including minority populations in clinical trials simply serves to widen the health gap that already exists. Furthermore, there are almost 57 million Hispanics living in the United States, but they are disproportionately underrepresented in Clinical Trials. “For example, while Latinos make up 17% of the U.S. population, they make up less than 1% of participants in NIH-funded re­search. Overall, Latinos make up between 6-7% of participants in clinical trials. This poses a challenge, as there are real differences in how people of diverse backgrounds respond to dif­ferent diseases.” (https://blog.unidosus.org/2018/03/06/all-of-us-research-program-unidosus-2/)

It is good for science. Appropriate participation of minorities in clinical trials offers the prospects of generating new hypotheses that affect treatments and products alike, exploring differences in responses to risk factors and treatment. Therefore, by including minorities we will be able to come up with better for all.

These are only a few of the reasons why we must include minorities in clinical trials. The problem lies not so much in understanding why it is important to involve these populations in clinical research but rather how to accomplish it. Since 1993 with the NIH Revitalization Act, there have been various attempts at policy changes that help address the gap of minority inclusion and yet almost thirty years later we still find that these groups are vastly underrepresented. We believe that the solution lies in involving all stakeholders in the process and rather than attempting to foster participation via policy changes. For example, getting pharma involved and committed to inclusion. This way minority enrollment can be something that is included as a success metric in clinical trials, making the data more reliable and ultimately leading to better science. 

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