The steps taken: Why clinical trials have a diversity problem

European Pharmaceutical Manufacturer editor Reece Armstrong looks at the issue of diversity in clinical trials and how medicines aren't developed with every patient in mind.

At a time of global upheaval, when marginalised voices are sounding out across the world, it’s important that we listen to what’s being said.

It’s also important that we look to the industries we work in and understand how we can be better, how we can support those calling out for it, and how we can affect real change in both small ways and large.

That this issue of EPM has been produced during the months of Black Lives Matter protests, Pride month in June, not to mention International Women in Engineering Day, shouldn’t matter. It needn’t take a movement or awareness raising events for us to consider how skewed our own perspectives can be of the goings on within our industries.

That the pharma industry isn’t immune to these problems should come as no surprise. Take clinical trials for instance and the lack of diversity that continues to be detrimental to marginalised groups.

Consider that in the US, it’s thought that less than 5% of African American’s are represented in clinical trials. Now consider the health risks people in those communities are at higher risks of – cardiovascular diseases, diabetes and even cancer. Finally, consider that the medicines designed to treat these conditions, might not have been created with representatives of these patients in mind.

We expect the medicines we take to work because they’ve been developed by extremely intelligent people who understand the complexities of biology and things like dissolution rates and excipients. But medicine, with all of its complexities, affects each of us in different, sometimes substantial ways. Unfortunately, the pharma market is geared towards a system that prioritises costs and can be obsessive with driving a product to market as quickly as possible. However, this is often at the sacrifice of diverse patient groups. The reason for this is that a more limited patient group presents less risk of adverse events, increasing the likelihood of success for that particular drug.

Progress is being made – though that doesn’t mean the issue should be pushed aside. In the wake of Covid-19, the UK has set up the NHS Race and Health Observatory to identify and tackle the challenges facing people in BAME communities. In the US, the FDA has taken a number of steps to both educate and make more transparent the issue of diversity in clinical trials.

These steps are definitely welcome – and long overdue – but it’s still only one area of life sciences that is seeing improvement. We need to continue to ask questions about how our industry operates and recognise and challenge when not enough is being done.