Promoting Diversity in Clinical Trials Series

One Size Doesn’t Fit All: The Current Demographics of Clinical Trial Participants

The COVID-19 pandemic has given us many lessons about the U.S. Healthcare System. One lesson we’ve learned is that illnesses can have vastly different effects on segments of the U.S. population. Unfortunately, those segments of the population that are often most affected can also be the ones that are least represented in clinical trials for treatments combatting those same illnesses. The health impact is that treatment outcomes observed in clinical trials cannot be generalized to the whole patient population. Potentially life-threatening outcomes or side effects unobserved in trials may be found in a broader patient population once a treatment has been approved. Oftentimes underrepresentation happens because of limitations in the study’s design and difficulty with recruiting and retaining participants and is not due to neglect by the study team. In this series, we’ll look into the current state of participant demographics in clinical trials and the importance of having representation from the potential patient population, what pharmaceutical companies can do to promote recruitment across diverse backgrounds, and how companies can work to understand the patient journey so that they can drive recruitment and retention from underrepresented populations.

According to the CDC (Center for Disease Control), there is increasing evidence that some racial and ethnic groups are being disproportionately affected by COVID-19. In a review of COVID-19-associated deaths reported to the National Vital Statistics System (NVSS) from May 1- August 31, 2020, the CDC reports that deaths among the Black population accounted for 18.7% of overall COVID-19 deaths despite representing just 12.5% of the U.S. population. Similarly, deaths among the Hispanic population accounted for 24.2% of all deaths, even though Hispanics represent 18.5% of the U.S. population. Inequities in social determinants of health can lead to increased risk for COVID-19 exposure among some racial and ethnic groups. For example, people from underrepresented racial and ethnic groups might be more likely to live in multifamily households, reside in congregate living environments, hold jobs requiring in-person work, have limited access to healthcare, or experience discrimination. Finally, the differences in prevalence of underlying conditions among racial and ethnic groups might also be associated with increased vulnerability to COVID-19 associated complications and death.¹

The different health outcomes of COVID-19 highlight the need for pharmaceutical companies and research sponsors to assure that clinical trial participants represent the potential patient population. Similar to the different effects illnesses can have on patient populations, vaccines and treatments may also have various outcomes and side effects depending on the patient population. It is important to understand the variety of these outcomes because a treatment may have a favorable result in one population but may not have that same result in another population. Unfortunately, minority populations are still underrepresented in clinical trials which could have a negative impact on the overall safety and efficacy of pharmaceutical products.

Photo by CDC on Unsplash

Analyzing clinical trial participant demographic data from treatments that received FDA (Food and Drug Administration) approval between 2015–2019 illustrates diagnoses in which the study population did not reflect the diagnosis’ overall potential patient population. For instance, African Americans are 1.5 times more likely to develop heart failure than Caucasians. However, on average only 3% of clinical trial participants for heart failure treatments were African American men while an average of 78% were Caucasian men. Likewise, in clinical trials for non-small cell lung cancer, African American participants only made up 3% average of all study participants even though African American men are 15% more likely to get lung cancer than Caucasian men.

And it’s not just racial or ethnic groups that are affected by underrepresentation in clinical trials. A study completed by the Yale School of Medicine compared health outcomes of clinical trial participants who received care for hypertension in low vs. high income sites. The study found that participants who received care in the lowest income sites were 25% more likely to be hospitalized or die due to heart failure and 25% more likely to die from any cause. Additionally, these participants were 30% less likely to receive common treatments for heart attack or chest pain and were 86% more likely to develop end stage renal disease. These results came even as these patients had fewer risk factors for hypertension, were less likely to have a family history of heart disease, Type 2 diabetes, or a history of smoking. While it’s been well-studied that social determinants of health can lead to health inequities, this study also suggests that more consideration for social determinants of health should be made when designing clinical trials to truly test drug efficacy. Even in randomized controlled clinical trials where every aspect of treatment is controlled and participants have equal access to care resources, participants from lower income areas face challenges with receiving care that are typically not faced by participants from higher income sites. For instance, participants from lower income areas may lack transportation and social support to get to a clinic and/or study site.² Research sponsors should pay close attention to where their participants live and the potential challenges that they may face with getting and staying on therapy as they are designing their trials. Participant demographics should not be the limiting factor that determines whether participants receive positive health outcomes from a treatment.

In an educational webinar hosted by Advarra on racial diversity in clinical trials, Jonathan Jackson PhD, Director of Community Access, Recruitment, and Engagement Research Center at MGH (Mass General Hospital) states that if you look beyond the FDA demographic snapshot, “clinical trials are really only good at representing one kind of person.” He goes on to say that the one kind of person represented in clinical trials is white, male, living along the east or west coast of the U.S., disproportionately wealthy, and likely to hold a Masters or Doctorate degree. If you do not have all 5 of these characteristics, then you are not represented in clinical trials. He goes on to state that people who are engaged in discussions about how to improve clinical trials are “super weird.” The same people who are trying to engage others on what it means to participate in a research study cannot connect with or relate to the average American because the average American doesn’t know what clinical research is or entails. Building in time to educate the average American on what research is must happen before you can expect to fully engage participants.³ There is still a lot of work to do to effectively promote clinical trial recruitment across diverse demographics and ensure that clinical trial participants are representative of the potential patient population, not just one specific population.

So, what can pharmaceutical companies and research sponsors do to promote diversity and increase enrollment of underrepresented populations in their clinical trials? Our next article “Promoting Diversity in Clinical Trials” will explore this question in detail.

References:

1. CDC. (2020, October 23). Race, Ethnicity, and Age Trends in Persons Who Died from COVID-19 — United States, May — August 2020. CDC. https://www.cdc.gov/mmwr/volumes/69/wr/mm6942e1.htm
2. Heath, Sara. (2019, August 1). Should Clinical Trials Account for Social Determinants of Health? Patient Engagement HIT. https://patientengagementhit.com/news/should-clinical-trials-account-for-social-determinants-of-health
3. Advarra. (2021, January). Racial Diversity in Clinical Trials: Building Trust in Participant Engagement. https://info.advarra.com/racial-diversity-in-clinical-trials-od.html?utm_medium=email&utm_source=marketo&utm_campaign=racial-diversity-in-clinical-trials-wbnr&utm_content=racial-diversity-in-clinical-trials-od-reg

Meet the Authors:

Meghan Sommerkamp is a Principal in Slalom’s Delivery Leadership Practice focused on improving patient engagement within Life Sciences and Healthcare.

April Ferguson is Director in Slalom Boston focused on Healthcare and Life Sciences. April is focused on leading global teams to define strategy, execute change and run operations for leading biopharmaceutical companies.

Audra Bieg is a Senior Delivery Principal in Slalom’s Delivery Leadership Practice focused on using human centered design to help Life Sciences organizations connect patients and caregivers with the solutions that make an impact.

Slalom is a modern consulting firm focused on strategy, technology and business transformation. Our healthcare and life sciences industry teams partner with healthcare, biotech and pharmaceutical leaders to strengthen their organizations, improve their systems, and help with some of their most strategic business challenges. Find out more about our people, our company and what we do.