My passion for diversity in clinical trials comes from many different places. For starters, I’m from a diverse community. It’s important to me that I, my family, and my children are well-represented in clinical research so we can have the best treatments and therapies available to us, should we need them.
My sister has a rare disease. Growing up, she wasn’t well and we didn’t know what was wrong with her. We went through years of treatments, trying to find doctors, trying to find answers. It’s only now, finding myself in this industry, I realize life could have been a lot easier for my sister and my family had we decided to participate in a clinical trial.
But that decision wasn’t easy to make back then. We didn’t have the awareness and we didn’t have the access. Now I want to use my voice to make a difference in this industry and actively advocate for more diversity in clinical trials – if we can solve this challenge, we can change the trajectory of peoples’ lives for the better.
Diversity in clinical research is a scientific and ethical issue
From a scientific standpoint, diversity is important because data isn’t complete if you’re not including everyone. If we aren’t including all populations in clinical trials, we can’t be certain a treatment works for everyone. This is critical because at the moment, drugs are still being approved and reaching the market with little data for minority communities, meaning there’s a risk of encountering problems when you administer those medications to those populations.
From an ethical perspective, everything is intertwined. We have huge disparities in healthcare for minority populations. But some of the disparities we encounter every day – from picking up prescriptions to regular physical exams – can be addressed if we tackle the clinical research side at the very beginning.
Ethically, it is our duty as an industry to work to remove disparities in healthcare, making it accessible for all and ensuring every community has the same high quality of healthcare. We have to make sure nobody is left out. There is no reason certain groups shouldn’t have treatments that work for them.
Overcoming barriers to diversity in clinical research
Certain communities are extremely close-knit. They tend to stay within the same areas, go to the same physicians, and get their information from the same places – perhaps a church, or community centre. These aren’t organisations that the clinical research industry speaks to.
Clinical research is usually confined to large teaching institutions, meaning sites like local hospitals or community centres servicing these minority populations aren’t asked to participate in clinical trials. And if they aren’t asked, how can we reach their patients?
Most patients are referred into clinical trials by a physician, they don’t open up clinicaltrials.gov and think, “Let me see what I’m going to sign up for today.” We have to build awareness on a community level with community hospitals with community sites to increase participation from both patients and healthy volunteers.
Going further, more clinical research awareness campaigns targeting the general population – our families, our neighbours, our kids’ teachers – are needed. Unless you’re working in the industry, you’d probably never think about clinical trials. COVID has changed that to an extent though because it’s made everyone aware of what a clinical trial is. Extensive public education has been necessary to get people to take the vaccines, to reassure them it’s safe, to explain what a clinical trial journey looks like, to make people aware of how many volunteers are needed. But education can’t stop just because we have the vaccine. If there had been more clinical trial awareness to start with, we wouldn’t have had to go to these extremes.
All of us deserve to have effective treatments and vaccines for new and existing diseases. To get there, we need public health initiatives telling people how they can participate, how they can contribute, and how clinical trials benefit not only them but the greater good.
Local clinics or hospitals aren’t often asked to participate in clinical trials. If a patient from one of these diverse communities happens to be referred for a trial – which is a huge hurdle to start with – they’ll likely have to travel long distances to participate.
When my sister was sick, we had to travel almost two hours each way to get her treatment. Often that trip was cumbersome, especially with other kids, and my parents needed to take time off of work. Sometimes, we’d drive to the site, stay in a hotel for a week as a family, then come home. Two weeks later, we’d do it all again. It was expensive, time-consuming, and one of my parents had to quit their job – that was difficult for us as a family.
When we talk about accessibility in clinical trials, this is what we’re talking about. When people have to take time off work it has a financial impact, and participation in clinical trials often needs upfront financial investment, even if you get reimbursed later.
To make clinical trials truly accessible to the broadest range of people, we need to start thinking about protocol design from the everyday person’s perspective. We need to ask, is this going to be feasible? Can they participate in these visits on this frequency? If they read the protocol, will they understand what is required of them? Addressing these considerations within protocols is the only way to make trials more accessible to these groups.
When it comes to clinical research, there are a lot of trust issues from the past, including histories of abuse within some communities. We have been naive to think these trust issues stop in the past. There are plenty of reasons right now why minority groups feel distrustful – not just of the clinical research industry, but the wider medical community. And they have nothing to do with events that happened 60-70 years ago.
We have to make sure everyone, no matter their gender or race, receives the same treatment and standard of care everywhere. If we don’t address these issues, there won’t be enough trust for people to participate in clinical trials where they don’t know what the outcome is going to be.
The only way we’re going to tackle trust is to make sure we’re having genuine conversations with community leaders and their organisations. We’re going to have to get out of our comfort zones and go into the community. We need to talk to pastors at churches, people who run food banks, schools and centres supporting these communities. We need to educate them on the clinical trial process and talk about ways we’re trying to end the disparities, so they can communicate this to the people who look to them for information. Until that happens, we’re not going to tackle the trust issue.
What do we need to do as an industry to improve diversity?
Someone recently told me the most important thing we can do is to come together. This isn’t a problem that’s going to be solved individually. We need to work together to figure out the best way forward.
Firstly, big pharma needs to engage the small, grassroots organizations that are organically tackling this. Most of these organizations are small and localized, but they’re powerful. They have the ear of the community, and they have innovative ways to reach them. When you’re in this industry, it can be difficult to look for grassroots solutions to problems. We want to find solutions that are tried, tested and true – but we have to try new things because this is a problem we haven’t solved yet. To do so, we need to expand our perspective.
Secondly, we need to make sure all clinical trials are collecting data on ethnicity. If we don’t collect that data, we won’t be able to see progress.
Thirdly, we have to make clinical trials accessible to all sites, of all sizes. That’s going to take a campaign in and of itself. When recruiting sites, large academic institutions are of course still important, but we also need to find smaller, under-the-radar sites to include. That might take more work, it might take an education effort, and it might take training – most of these sites have probably never participated in a clinical trial – but it will be worth it.
If we consider everything that needs to be done on a legislative and regulatory level, it can feel overwhelming. But if we take little steps, those little steps will add together, they will result in small outcomes and those small outcomes will result in bigger change happening. We can’t allow ourselves to be overwhelmed by everything that needs to be done. We need to start wherever we can.
How mdgroup is addressing diversity in clinical trials
For clients truly interested in tackling diversity and actively putting together initiatives to drive inclusion, we create programmes to support them each step of the way.
We already offer many solutions that increase accessibility for clinical trials, making sure patients are well cared for, that they aren’t out of pocket for any expenses, and providing travel stipends and reimbursements. We’ve also developed mobile health solutions so patients don’t have to travel as frequently for site visits, they can have a nurse come to their home instead.
We take it a step further for D&I initiatives, working with partners who are actively engaging communities of colour.
They can go into these communities and raise awareness for specific clinical trials to increase enrolment. We also can help map out key locations for increasing diversity, advising you which cities and regions you need to target. We’ll talk to you about your protocol and how we can support you to make changes to the protocol design to increase accessibility for diverse populations.
This is work we are excited about doing – working closely with organisations to put solutions into action and see the rewards of increasing diversity in patient populations.
We’re also launching our brand new mdTalk series with a focus on diversity in clinical research and healthcare access. I am so excited to have the opportunity to talk to thought leaders in this industry who are just as passionate about patient centricity, diversity, and about making clinical trials more accessible as I am.
Right now, diversity is something everyone in the industry is discussing, but no one knows where to start. With mdTalk, we’ll be talking to incredible individuals and organisations who have spent significant time researching diversity and coming up with solutions. They all have valuable insights that our industry can take to heart, and use.
Our goal is to bring those insights to a wider audience and encourage people to go back to their organisations, start D&I initiatives or implement new ideas that they’ve never thought of before.