The under-representation of racial and ethnic minorities is a well-documented issue that affects clinical trials around the world. Studies show that people from specific demographics respond to treatments differently, with some minority populations even facing worse health outcomes from certain diagnoses.
Here, we look into the issues faced when people of white, European descent are over-represented in clinical trials, the benefits of a diverse patient population on trial outcomes, and how researchers can engage with minority populations to increase diversity among participants to improve overall drug development.
Why is there such a lack of diversity in clinical trials?
Age, genetics, gender, weight, racial heritage and even geographic location can play a role in how effective treatment could be or how safe it may be to an individual. However, clinical trials rarely target all of the possible subgroups to address these factors.
Effects of diversity among trial participants on clinical development
Having a less diverse participation base to work with can impact the advancement of health research, as drugs may be developed without being tested on as many people from different genders or ethnic backgrounds, this means we don’t know whether treatments are equally effective for all racial populations.
Doctors may also diagnose conditions or prescribe medication that will work well for individuals with European genes, but that can be less effective for those from other racial backgrounds. They may need a higher dosage or a different treatment altogether. Likewise, common medical advice may also be invalidated when applied to different demographics.
In the largest study to date of different ethnic populations across the US, there was no correlation between UV exposure and melanoma incidence in black or Hispanic populations. Studies assessing these associations have historically excluded patients with darker skin types and, worryingly, this lack of diversity is not only a problem in dermatological research but across all healthcare.
The benefits of patient diversity in clinical trials
Subgroups of different ethnicities and genders may respond differently to the same medical therapy – a problem which is alleviated with a non-homogenous sample of participants at trial stage. If sponsors and researchers want to develop treatments that are equally effective for the whole population, they should aim to represent each subgroup equally.
Not only will increased diversity among clinical trial participants result in better treatments globally, but there are many other benefits too, such as:
- Faster and less expensive trials
Including individuals who share certain biomarkers means it is possible for researchers to include surrogate markers as an alternative way of measuring outcomes.
- Better trial participation rates
Researchers seeking more diverse participants will have to extend awareness outside the typical clinical trial demographic. By reaching out to new audiences, trial participation rates will rise among these demographics.
- More reliable results across the census
Medical research will begin to reflect society, as a whole, rather than attempt to assume data from affluent participants of white, European heritage across an entire population.
What needs to happen to make clinical trials diverse
Researchers should be making sure that not always the same people from the same area and the same social-economic and educational backgrounds end up in research; that there is more diversity across the range.
Engaging with minority communities
Real demographics can be found in your own local community, it is where people go and where the natural populations are. But unfortunately, there’s a couple of big barriers to allowing these populations to participate in clinical trials, and mostly, it is about opportunity.
Investigators play an important role in bringing trial awareness to the patient to increase diversity in patient populations. According to Lynch, there’s a larger need for diversity among researchers themselves, as patients are more likely to trust and participate in clinical research when they believe in their doctor.
Make diversity an internal focus
For the industry to make headway in terms of diversity, research and clinical teams should make diversity a priority – from investigators to participants.
Increased diversity is crucial for the future of clinical research
Despite medical research slowly waking up to the intense need for diversity within clinical trials, the industry still has a long way to go.
Differences between people, such as age, gender, racial background and geography, can lead to wildly different effects from the same treatment, and some groups may experience completely different results from the majority.
When the people who would really benefit from drug development are misrepresented, can we really mark a clinical trial as successful?
For diversity and equality goals to be achieved among clinical trials, teams need to be more dedicated in orchestrating change. All stakeholders play a role, and should make diversity in clinical trials a priority to begin to see real differences in the industry.
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