The science behind diversity: Why we need to act now to demand diversity and inclusion
At Demand Diversity, we’ve always been determined to improve diversity within the industry and we hold ourselves accountable to making it happen. We believe it’s important for us to constantly raise awareness around the lack of diversity in clinical trials, until a difference is truly made.
That’s why in this blog, we’re going back to the basics to explain why it’s so important for us to make a change.
There’s a lack of diversity in clinical trials
We’ve said it before, but we’ll say it again: there’s a lack of diversity in clinical trial populations. This means that certain people are often left out of clinical trials and are missing the opportunity to participate in research for potentially lifesaving treatments.
Why is it so important for clinical trials to be diverse?
Beyond it simply being the right thing to do, and that everyone should have equal opportunity to contribute to research and society, there are important scientific reasons too.
Many factors — including age, gender, and ethnicity — can play a role in the way a person reacts to a drug. Not only this, but people of a certain age, gender or ethnicity can also be at a higher risk of developing certain diseases. So, it’s important for clinical trials to be diverse to ensure that the drug or device being investigated is safe and effective for those who need the treatment the most.
Unfortunately, those who are involved in clinical trials are often not representative of all ages, genders, and ethnicities, which means the drug or device that is being investigated may not be the most safe and effective option for all groups, and therefore may not help those who really need it.
Not only that, but one of the major issues is that a lack of diversity is causing an impact on genetic testing. More and more evidence has come to light that ethnic minority groups are underrepresented in human genetic studies, meaning their data is being left out of huge genetic databases. In short, that means that only certain populations will receive a diagnosis due to the data that’s available.
How do we know this? Well, recent study results speak for themselves:
1) It’s been found that Black, Indian, Pakistani and Chinese participants are all underrepresented in the UK Biobank, a huge genetic database, by at least one third. This could mean that in the future, white people could be offered genetic tests for certain health conditions, while other people could be offered incorrect or no testing at all.
2) A 2018 analysis of studies looking for genetic variants associated with disease found that 78% of study participants were of European ancestry, compared with 10% of Asian ancestry and 2% of African ancestry.
3) Another study looked closely at publications that used data from the UK Biobank and the US Health and Retirement Study; these biobanks support genome-wide association studies, which scan data from thousands of participants to find genetic variants associated with disease. The results found that, overall, 45 of 58 studies in the sample excluded minority data. And when this is converted to the number of times the data from an individual were actually analysed, minority representation in the UK Biobank falls to 0.06%. So, shockingly, even when the data for minority groups is there — it’s not being analysed.
By excluding data from minority populations, scientists are losing the opportunity to build knowledge about health conditions in different ethnicities, and potentially denying certain populations of the chance to the most safe and effective treatments for them.
And this is just one of the many reasons that proves why it is so important for us to make a change.
What makes us different
We know how it can sound; many people have fought long and hard for equality, yet we’re trying to say everybody is different. The truth is, we’re all unique and there’s no doubt about it. Each and every one of us has a certain make-up of genes that makes us who we are. However, this doesn’t mean the level of care we receive should be different. And that’s why it’s so important for us to improve diversity in clinical trials.
It’s a known fact that there are some differences that can make people more susceptible to developing a certain disease, despite sometimes not knowing the reasons behind this. Examples include:
Women and different ethnic groups are more susceptible to certain autoimmune diseases. For example, African-American, Hispanic, Asian and Native American women are two to three times more likely to develop lupus than Caucasian women. Plus, 9 out of 10 people who have lupus are women.
Women suffer from migraines three times as often as men.
Caucasian and Asian women are more likely to develop osteoporosis than women of other ethnic backgrounds, and women over the age of 50 are the most likely people to develop osteoporosis.
Africans, African Caribbeans and South Asians are more likely to develop Type 2 diabetes than the rest of the population.
With there being many more statistics like these, it is time to make a change.
How genes affect a person's response to treatments
Not only can our genes (and other factors) influence our susceptibility to disease, but our genes can also affect how we respond to treatment. People of different ages, different ethnicities, and different genders can all respond differently to the same drug or device. One example of this is how long it takes for a drug to be absorbed can differ between genders: a study found that absorption of enteric-coated aspirin was delayed in women compared to men, following a meal. Therefore, women should wait longer after eating before taking medications that must be taken on an empty stomach. And to add to this, it’s worrying that we struggled to find recent data surrounding this, as it further confirms the lack of research around gender differences when it comes to clinical research. Plus, ethnicity can also play a role in the way that a drug works within the body, with factors such as genetics, body size and fat distribution contributing to differences in absorption, distribution, metabolism and elimination of drugs.
It isn’t just our genes that can have an impact on our response to certain drugs, as hormones can also play a part. And changes in hormones throughout our lives, including increases at puberty, changes with pregnancy, and decreases with age, could affect drug absorption, distribution, metabolism, and elimination.
So, if there’s a drug being investigated for lupus, yet most of the people taking part in the clinical trial are Caucasian men, how can we be sure that the drug will have the same effect on women from different ethnicities (those who are more likely to be living with lupus)?
The same scenario applies across other situations too. If most of the trial population are white, how can we be sure that the drug or device will have the same effect on Black people? Or if most of the trial population are young adults, how can we be sure that the drug or device will have the same effect on the elderly population?
It’s clearly time to make a change.
Why does the lack of diversity exist?
Unfortunately, lack of diversity is common across many types of clinical trials, and the reason behind this can be due to a number of reasons, including but not limited to:
Lack of awareness and knowledge around clinical trials
Mistrust within the industry
Language and cultural barriers
But ultimately, at Demand Diversity, we believe the patient recruitment model for clinical trials is broken. Here’s why:
Traditionally, the clinical trial site has been left in control of patient recruitment
Did you know clinical trial study sites struggle to keep up with the referrals they get from patient recruitment campaigns, with one-third never being processed? Clinical trial study sites have limited resources to manage large volumes of referrals, and finding patients who actually qualify out of the large number of referrals is an additional challenge. And while sites are processing referrals from patient recruitment campaigns, they could be missing out on potential participants from their own database too.
Recruitment materials are not carefully considered
Before joining a clinical trial, patients should have access to all the need-to-know information in a format that is easy to understand. Unfortunately, patient recruitment materials are often developed by study teams that focus heavily on the wording of the study protocol, without considering patient-friendly terms. And what’s more, materials are often developed on a global level, without taking into account differences across populations. That’s where health and cultural literacy is important.
Digital recruitment cannot be used as a sole approach
Digital outreach can enable a large amount of people to be reached in a short amount of time, so it’s understandable that many will turn to this as a solution for patient recruitment. However, it cannot be solely relied upon.
With 2 million daily users, Facebook is a powerful way to reach patients, but it’s targeting options for advertisements are limited. One major change is that Facebook has withdrawn the specific 'multicultural affinity’ targeting option, which leads to the question of how this might affect patient recruitment that aims to improve diversity in clinical trial.
Digital alone can never be enough, and the industry needs a model that focuses on community outreach too, in order to gain valuable patient insights and build trusting relationships.
Deep scepticism, concerns and uncertainty around the intentions of clinical trials exists in many communities. That being said, action needs to be taken to improve trust and change people’s views that could be influencing their willingness to take part.
One way this can be achieved is by gaining validation from respected community institutions and figures. Long-term, trusting relationships can be built by educating the communities we seek to serve, sharing information about the personal benefits and risks associated with participating in clinical research, and taking steps to address any concerns that minority communities have regarding exploitation. Plus, buy-in from community advocates, representatives or medical staff from ethnic communities (who are already trusted within their communities) to help educate and raise awareness has the potential to break down barriers.
It’s clear that a digital approach alone would not be enough, and community outreach allows for more meaningful connections and trusting relationships to be made.
The main message
The key takeaway here is that there are scientific differences based on gender, ethnicity, and age, and the current recruitment model is not representative of these diverse populations. Therefore, changes need to be made to ensure everyone has an equal chance to potentially life-saving treatments, no matter their age, gender, race or ethnicity.
At Demand Diversity, it’s our responsibility to address any barriers that could deny someone the chance to join a clinical trial, and that’s why we’re holding ourselves accountable to ensure the recruitment model is improved. Ready to make a change? Join us in demanding diversity.