We recently released the results of our latest big data analysis, showing that 42% of US cancer trial cohorts do not include any African American patients, and 48% have no Hispanic American patients. The analysis spanned 589,295 patients participating in 6,372 US-recruiting cancer clinical trials over the past 15 years. The results highlight an urgent need to increase enrollment of underrepresented racial and ethnic populations in clinical trials to ensure that drugs developed would benefit the whole population.
A failure of patient care
According to the 2020 US Census, Hispanic or Latino people make up 18.7% of the US population, and 12.1% are Black or African American. Collectively, this means a third of the US population are not represented in clinical trials for cancer.
The lack of diversity in clinical studies is a known issue. As an industry, we must move away from a ‘so what?’ mentality and recognize the severe impact these shortcomings have on patient care. According to the American Cancer Society, Black people have the highest death rate and shortest survival rate for cancer of any ethnic group in the US, and are at a greater risk of developing stomach, liver and cervical cancers.
Drugs that emerge from trials conducted in a cohort that is not representative of the whole population could be less effective in other ethnic groups, or even have adverse effects. Biological differences mean people might respond differently to different therapies. For instance, variations in genetic coding can make a treatment more (or less) toxic for one racial or ethnic group than another.
Bridging the diversity gap
Solving the diversity gap in clinical development will require a two-fold effort. The lack of diversity to date is caused partly by a historic lack of equitable healthcare in the US. With trial recruitment sites typically selected based on quality of facilities and equipment, which excludes already disadvantaged communities. In addition, sponsors must make better use of the data available to them. Data is available to help sponsors identify appropriate recruitment sites and select patients that represent the population.
In our conversations with Dr Otis Johnson, Vice President, Product Line Executive at Clario, he described our analysis as underlining “significant failings in clinical trial design and recruitment”. By taking a data-driven approach to selecting diverse cohorts from the early stages of clinical trial design, sponsors can tackle failings in diversity and ensure they are developing drugs that are safe and effective for all – not just a select few.