Patient diversity in clinical trials: why the lack of diversity in trial participants?

This is the second of three blog posts looking at the reasons for the lack of diversity in clinical trial patients. The first part explores how COVID-19 has led to greater awareness for more patient diversity in clinical trials and the third looks at what the future holds.

As discussed in our last post, patient diversity in clinical trials is important, but ensuring research represents the wider patient population that treatments and vaccines intend to help is a long-running challenge. Age, gender, race and ethnic background need to be appropriately represented in clinical trials.

The long-running challenge of patient diversity in clinical trials

In 1985, a task force commissioned by the US Public Health Service recognised that environmental, economic, social and demographic characteristics all influence an individual’s health status. It also highlighted that the low representation of women in research had led to sub-optimal women’s healthcare. 

The impact of this report and subsequent focus on women’s health – which continues today) – forced wide-ranging change in recognising that the health of women (individually and as a community) needed better focus

The National Institutes of Health (NIH) in the US released a 1986 policy advising scientists to examine differences in sex/gender in the study outcomes. This later became law (the NIH Revitalization Act 1993). Alongside subsequent NIH guidelines, the Act requires women and ethnic/racial minorities to be enrolled into NIH-funded clinical trials. It aims to ensure that all people, regardless of sex/gender or race/ethnicity, are able to benefit from medical advances. 

How successful have past initiatives to promote patient diversity been?

Despite the introduction of the NIH Revitalization Act, a 2014 report focusing on minority participation in cancer trials found that less than 2% of the National Cancer Institute’s clinical trials focus on any racial/minority population as their primary emphasis.

Meanwhile, another report published one year later, which looked at compliance with the Act and other guidelines in NIH-funded research and compared results against previous reports compiled in 2004 and 2009, highlighted that there have not been significant increases in reporting results by sex, race or ethnicity, despite the policies in place

There is undoubtedly still a way to go to achieve adequate diversity in clinical trials. Despite the US Food and Drug Administration (FDA) reporting that 46,391 people participated in clinical trials during 2019, the breakdown of this data according to ethnicity leaves a lot to be desired. Of these participants:

  • 72% were white
  • 9% were black or African American
  • 9% were Asian
  • 18% were Hispanic

And with the race currently on to find a vaccine for COVID-19, trials to date have generally consisted of predominantly white patient populations. In the UK, a joint effort by the University of Oxford and AstraZeneca has reported good results from initial trials, but out of the 1,000+ healthy adults who took part, 95% were white, 5% were Asian and less than 1% were black.

Likewise, a similar trial in the US being conducted by the Moderna biotech company, which has also had encouraging results so far, involved 45 adult participants. Nearly nine in 10 (89%) of the participants were white. The lack of diversity in these two trials prompted experts to warn that a lack of diversity could undermine clinical research

It’s a concern we echo and have spoken about extensively, including how the medical research community, pharmaceutical companies and funders must work together if we are to be successful in tackling the issue of diversity in clinical trials. 

Why is patient diversity in clinical trials still such a challenge?

In our first blog post about patient diversity in clinical trials we highlighted how the COVID-19 pandemic has shown the importance of getting better representation of the wider population in clinical trials. 

Despite specific policies and initiatives to address this issue – such as the FDA’s ‘Year of Clinical Trials Diversity’ campaign – some of the main barriers continue to be:

  • the perception of clinical trials and the worry of being a ‘guinea pig’ for potential new medicines
  • mistrust of pharmaceutical companies
  • concern of being stigmatised due to participating in a clinical trial. This can be both a direct concern of the individual and can come from friends, family and the wider community
  • a lack of education and general understanding of clinical trials, including not understanding the process and being unsure of how it may affect existing care or treatment being received
  • Not fully understanding the fundamental purpose and value of clinical research.

Other practical impacts of trial participation that may prove to be a barrier for some people include; financial considerations such as taking time off work to attend visits and transportation costs that may be involved, and the time demands that participation may have. 

Finally, awareness and access can also be a big factor – many people are simply not aware of active clinical trials and that they may be eligible, or they do not have access to physicians conducting clinical trials. 

Overcoming barriers to patient diversity in clinical trials

In an effort to overcome the barriers to clinical trial participation many companies and institutions have implemented initiatives to try to improve the situation. This includes working with communities to improve information and access to clinical trials, but more can and should be done. 

For example, the FDA introduced guidelines in the US to help those who enrol patients into trials increase diversity. But these guidelines are not mandatory; we need to go further, and together, if we are to truly tackle this issue. 

The industry’s approach to patient diversity needs a rethink. People need to be put at the heart of clinical trials and they need to be reached in ways and means that are best for them. From our own experience, we know that community outreach is vital in building relationships and trust; in the past, our team has used churches, grocery stores, hair salons and gyms as locations to talk to people about clinical research and found them to be much more receptive to trial information than they may have been otherwise. 

But there’s so much more to do than just focus on community engagement. We need everyone involved in the drug development process — from funders and researchers to drug manufacturers — to come together and take an integrated approach to tackle this inequality

In our next blog post we will discuss in more detail what still needs to change to ensure clinical trial patient participation adequately represents those most in need of the potential treatment or vaccine being investigated.

Ensuring adequate patient diversity in clinical trials is an issue that Innovative Trials takes very seriously. We work hard to help our clients recruit and retain trial participants that are representative of the patient populations most in need of the treatment or vaccine in development. Find out more about how we can work with you to help ensure patient diversity in your research.

Request our latest Diversity Outreach Case Study