Patient diversity in clinical trials: why we need practices to change

This is the first of three blog posts looking at the issue of patient diversity in clinical trials. The second part is about why there is a lack of diversity in clinical trial patients and the third explores what the future holds.

Patient diversity in clinical trials is important, but ensuring research represents the wider patient population that treatments and vaccines intend to help has been a long-held challenge. Age, gender, race and ethnic background need to be appropriately represented in clinical trials; the coronavirus pandemic has shown just how important it is to get this right.

COVID-19 began to spread throughout the world at the start of this year, with the World Health Organisation (WHO) officially declaring a global pandemic on the 11th March 2020.

Lockdowns and restrictions were brought in to limit this spread, affecting our lives significantly – who we could see, where we could go, what we could do. But it also brought us together. There was perhaps even a global solidarity in being in the same position; trying to stop the spread of the virus, get it under control and the race to find a vaccine.

The issue of diversity in regards to Covid-19 began raising its head in April when data started showing that people from black, Asian and minority ethnic (BAME) backgrounds were being disproportionately affected by the virus. In the UK, this was brought to light by media reports about the healthcare staff that had lost their lives . The subsequent analysis of available data for how healthcare workers were being affected, and the proportion of hospitalised patients with COVID-19, prompted the UK government to announce a review into the impact of COVID-19 on BAME communities.

According to the UK’s Office for National Statistics (ONS) black men are around twice as likely to die from the virus than white men of the same age while the risk for black women is 1.4 times greater than for their white counterparts, once factors such as socio-demographics, household characteristics and geographical location had been taken into account. Men of Bangladeshi, Pakistani and Indian ethnic backgrounds also have a significantly higher risk of death involving COVID-19 than white men.

Meanwhile in the US, data shows trends for black or African American people and Hispanic or Latino people being disproportionately affected by the virus. The Centres for Disease Control and Prevention (CDC) had studies underway to confirm the data and better understand and reduce the impact of COVID-19. In Australia, steps to protect remote and rural indigenous communities have been taken, mostly through strict restrictions on travel in and out of those communities. These communities have a high incidence of other conditions, putting them at greater risk of COVID-19.

The need for greater patient diversity in clinical trials

Whilst the race was on to develop a vaccine, in the light of this emerging information, calls were being made to ensure BAME populations were appropriately represented in the clinical trials.

Patient diversity in clinical trials has long been a topic of discussion within the life sciences industry. In 2016, the US’ Food and Drug Administration (FDA) launched its ‘Year of Clinical Trial Diversity’ initiative to highlight the need for greater diversity. According to its own data on global participation in clinical trials between 2015 and 2016, almost 4 in 5 people (78.6%) who participated in a clinical trial were white.

Why patient diversity in clinical trials is important

Disease and illness do not discriminate, but our age, race and ethnicity do play a part in determining how conditions and the medical products used to treat them affect us.

Cardiovascular diseases are the number one cause of death globally according to the WHO , and we know people of South Asian, African or African Caribbean

descent in the UK are at higher risk of developing some heart and circulatory diseases than white Europeans. The reasons for this are complex and multi-faceted; lifestyle choices and other factors that can affect lifestyle play a large part, but genetics also has an impact.

And yet research continues to allow these populations to fall ‘under the radar’ when it comes to research: writing in the US journal Circulation in 2019, researchers acknowledged that cardiovascular research in general has not represented those from ethnic minorities as well as other, broader groups such as the elderly.

If we do not include people in clinical trials who are more likely to be affected – or affected much worse – than other groups, we risk results becoming skewed. How will we know if a treatment is truly effective for those who really need it if we don’t include them in the research?

The importance of patient diversity in clinical trials has been discussed for many years, but it’s an issue that has predominantly stayed ‘behind closed doors’. Traditionally, little has been reported in mainstream media about clinical trials, which means the public’s understanding, awareness and importance of clinical trials in broad terms is limited. In the past, the general public only tended to hear about trials when something went badly leading to perceptions of patients as guinea pigs and a mistrust of pharmaceutical companies.

Pre-COVID-19, public education initiatives by the life sciences sector started shifting perceptions, but the global pandemic has shone a spotlight on the necessity for clinical trials like never before. The development and testing of potential treatments and vaccines is reported regularly in newspapers and primetime news, raising awareness of just how important clinical research is.

And there has been a real movement for change in terms of diversity and equality. Black Lives Matter protests have fuelled conversations around discrimination and diversity, with all of us recognising the need for more diversification and better representation of those from traditionally marginalised communities.

The combined effect of all this has brought the importance of clinical trials, and diversity within them, to public awareness in a way not perhaps seen before. The Guardian, Bloomberg and ABC News all ran pieces focusing on the importance of diversity within COVID-19 vaccine trials as they approach phase three. Public awareness of these issues are high and there is real opportunity to make significant progress in both the education of clinical trials in general, and the importance of ensuring diversity within them.

Patient diversity in clinical trials is an issue that Innovative Trials takes very seriously. We work hard to help our clients recruit and retain trial participants that are representative of the patient populations most in need of the treatment or vaccine in development. Find out more about how we can work with you to help ensure patient diversity in your research.