Diversity in clinical trials: The powerful need to improve it!
“One size fits all” is rapidly becoming an outdated concept in modern-day life, and medical research is no exception. Without diversity in clinical trials, any major discoveries are only valid for the sample of the population used.
So far, we aren’t doing too well in this area. It’s not difficult to find cases of poor diversity in clinical trials. Just take a look at the September 2018 article in ProPublica that reported on U.S. cancer drug trials. African Americans comprised less than 5% of trials for drugs approved in the past four years. Since 20% of all U.S. multiple myeloma patients are from this 12% of the population, the current ratio is, quite frankly, ridiculous.
Why diversity in clinical trials is vital
Clinical trials provide valuable insights for the medical community on how people are likely to respond to treatments and to determine the best ways to use them. Differences between people can lead to widely different effects, depending on factors like age, gender, weight, ethnicity and even geographic location. Different groups may need alternative dosages, experience completely different results, and even have distinctive side effects.
Thankfully, we’ve made progress since the days when most clinical trial participants were white males, which left lots of unanswered questions about the usefulness and safety of the treatments when it came to women, children and other racial groups.
Reasons for the lack of diversity in clinical trials
So, why is this even happening still, in these days of improved racial awareness and equality? Part of the problem lies in the recruitment challenge facing pharmaceutical companies. Some of the barriers to recruitment are basic ones, such as economic, linguistic, cultural, religious or perhaps even physical, as in difficulty accessing particular locations. In many cases, participants are referred by doctors or medical centres, which have a higher percentage of some demographics than others.
Even when recruitment is successful, retention is as much—if not more—of a challenge, with some people struggling to be available at certain times due to work commitments, or for those without private vehicles to attend locations that require traveling more than a nominal distance.
Some ways to address the problem
Like most complex problems, there’s no easy, one-stop answer to the lack of diversity in clinical trials. What there is, however, is a sound acceptance of the need for change, and a willingness among pharma companies to do whatever it takes. This is resulting in a number of initiatives, ranging from rethinking the way trial participation is marketed, to taking account of a variety of religious and cultural concerns.
In the U.S., the National Institutes of Health (NIH) recently launched its “All of Us” research program, which is an historic effort to gather data from one million or more residents. The Federal Drug Administration (FDA), meanwhile, is considering the development of incentives for sponsorship of trials specifically targeting underrepresented populations.
And, in the U.K., there’s recognition of the fact that emerging technologies can improve performance in clinical trials by removing barriers to participation and improving enrolment levels.
Benefits of improving diversity in clinical trials
It’s not only pharmaceutical companies that will benefit from having a broader target audience to market their products to. By enrolling minority patients in trials, we will be able to improve the likelihood that they will benefit from the research. The results of the trials will be relevant to more segments of the population, and studies suggest that by improving access to trials, we may well succeed in improving access to healthcare services generally. The outcome of this will be better health equity for everybody.
Medical products are safer and more effective for everyone when clinical research includes diverse populations. Whether the target population for the treatment on trial is as specific as ‘Men during their reproductive years’ or as broad as ‘Adults who have been vaccinated against measles,’ having a cross-section of racial and ethnic groups is beneficial.
In some instances, people who do different types of work, eat certain types of food, or have a particular exercise profile may respond differently than others to a specific treatment.