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The Increasing Need for Diversity in Clinical Trials

Industry Challenges
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August 18, 2024
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Life Sciences

Participants for clinical trials have historically been majority white, with only a small percentage of people of color being represented in patient numbers. This topic received even more attention during the COVID-19 pandemic of 2020. According to data from the FDA in 2020, 75% of participants of clinical trials were white -- a stark contrast to the participation rates of other racial and ethnic populations. In the US, 40% of the population belongs to a minority group, so the rate at which minorities participate in studies does not reflect a true sample of the population. Let's take a look at the why behind the underrepresentation, the harmful effects if we don't work towards including more diverse panels of participants, and what can be done to combat these misalignments.

Why have clinical trials been majority white?

Lack of diversity in clinical trials has been a longstanding problem for a number of factors. Universities are sometimes typically located in areas where nearby neighborhoods and residents only represent a small racial pool. Access to specialists and consistent healthcare has also been a dominant factor for people of color. Due to lower paying or inconsistent jobs, many do not have consistent health insurance coverage to regularly see doctors and remain in the circle of influence and exposure to be privy to clinical trials and eligibility.

On top of this, boards and decision makers who are affiliated with research studies are typically white males. This brings an added layer of bias whether it be conscious or unconscious to grants, study design, and site locations. Minority groups can also have fears of not being taken seriously, or heard when it comes to their health and can feel dismissed by the professionals that should be entrusted to help them manage their health. Distrust amongst medical professionals and fear of immoral research practices targeted towards minorities is a long-running issue amongst many racial groups.

What is the harm in not seeing diversity in clinical trial participants?

Underrepresented groups are disproportionately burdened by illnesses and poor health, however they are historically not represented well in clinical trials. Diversity in clinical trials helps to ensure that findings are safe and effective for all populations. In addition, many illnesses impact certain racial groups far more heavily than others. If the patients in the studies aren't coming from those groups that are more highly effected than others, there may be disparities in how well a patient will respond to the treatments and therapies being studied when they are used in the real world.

Outside of diverse patient participation, it's also important that those who are employees of research companies come from a diverse pool as it helps to bring various points of view to help combat unconscious bias. Diversity amongst employees is also proven to produce more innovation by bringing together different perspectives and experiences.

What can be done to make trial patient panels more diverse?

Many pharma companies are taking steps to make sure that diversity is a standard in their clinical trials. These organizations are actively making sure their workforce is diverse as well. One of the most important things research organizations are doing to help make panels more diverse is by facilitating trust and transparency between their organizations and minority populations. Unfortunately, in the past some research organizations have performed studies or procedures on patients without their consent or knowledge and exposed them to dangerous illnesses or chemicals. These clandestine and immoral activities lead to generations of certain racial and ethnic groups being extremely untrustworthy of researchers and medicine in general.

Another way to increase diversity amongst trial participants is to offer hybrid participation options for site visits. Due to socioeconomic status, it may be very difficult for certain groups to miss work, secure childcare, or even find timely transportation to physically report to a site. Hybrid participation options help to make the sometimes time consuming commitment of being a trial participant a bit easier to manage. In addition, selecting sites that are located closer to areas where diverse populations live can prove to be extremely helpful in diversifying the participant pool.

When it comes to patient recruitment, research organizations should form strong partnerships with various organizations that will help them to reach a broader audience than they could on their own. Becoming approved to become a participant normally requires adherence to strict eligibility guidelines. By relaxing these guidelines, researchers open themselves up to a greater population of participants.

What does the future have in store for us?

With the acknowledgement that there are enormous disparities in the participation rates of racial and ethnic groups, has come the dedication from researchers to actively pursue solutions for this dilemma. More than ever, we have numerous organizations working in concert to bring representation to research and medicine. Although it may take time to truly see equality in numbers amongst participants, we are moving in the right direction as long as we continue to see the world outside of ourselves.

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