June 2020: diversity and inclusion in clinical trials round-up
There’s been a big light shining on the lack of diversity in clinical trials recently. And shrugging our shoulders is no longer acceptable in the industry. Read on for the latest news surrounding the issue, that was published in June 2020, including the most up to date stats and who is taking the lead in trying to drive change…
A call for diversity and inclusion in clinical trials
Approved drug trials too often fail to report participant ethnicity in the US. So it’s not clear just how inclusive these trials are. With this knowledge not sitting well with those looking to improve diversity, action is being taken to make change happen.
For example, the Alliance of Multicultural Physicians has written to the FDA, urging them to make diversity in clinical trials a greater priority as they explain the shocking statistics from COVID-19 cases in the US, where the death rates are:
White Americans – 22.7 per 100,000 in the population
African Americans – 54.6 deaths per 100,000
Hispanic Americans – 24.9 deaths per 100,000
Asian Americans – 24.3 deaths per 100,000
The letter also states that most approved drug products come with an FDA disclaimer, explaining that there’s insufficient availability of data to determine effective response in ethnic minority patients due to a lack of participants.
Read more about the letter that hopes to create change, address a longstanding lack of diverse participation in clinical trials, and in turn, the disparities in COVID-19 cases and deaths in racial/ethnic minority communities.
Does where you live make you biased against diversity?
The Pew Research Centre spoke to over 28,000 people from 11 different countries to see if diversity is viewed differently around the globe. It turns out, it is:
In India, 68% of participants saw diversity making their country a better place to live.
Participants from Lebanon saw diversity unfavourably. This could be due to the influx of refugees in Lebanon, where 70% of participants view refugees unfavourably.
54% of Colombian participants and 48% of Mexican participants view migrants arriving there unfavourably.
Take a closer look at the results for how views on diversity vary between countries.
Technological advances in medicine demands diverse patients
In the era of genomics and precision medicine, Forbes report that it’s vital for a diverse range of participants to be enrolled onto clinical trials. They note that advances in technology are helping to increase awareness and inclusivity of clinical trials. And in the future, technology will be vital to drive better research and treatment development, ensuring that historically excluded communities are given equal access to healthcare and clinical trials.
Better framework for Haematologic Malignancies Cancer patients
In this article, Cancer Network addresses cancer incidence, prevalence, burden of disease, mortality, and survivorship within the Black, Asian and ethnic minority (BAME) communities, in particular haematologic malignancies, and how it’s affecting them negatively. They’ve created a framework to encourage better results for patients from a minority background which include clinical trial awareness, education, and care coordination, leading to what they hope to be an increase in patient engagement. Read more about the proposed strategies, here.
4 easy ways to improve diversity in trial populations
According to Kathryn Stephenson, MD, and Bisola Ojikutu, MD, who both serve as directors of infectious disease research, 40% of participants need to be Black or Latinx in order to represent real-world outcomes for COVID-19 treatment in the US. They’ve pointed out some simple steps that researchers can take to ensure their trials accurately reflect the populations that the treatments in question will serve, to increase diversity ratios. From acknowledgement to appreciation, find the 4 steps here.
Insights into increasing the community of minority investigators and study staff
Tufts Center for the Study of Drug Development (Tufts CSDD) and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. They held advisory boards, which discussed the importance of trust, language equity, establishing a safe environment, community engagement, technology and more. Read the detailed insights and get the key recommendations here.
Cultural understanding to improve trial participation
A barrier that’s spoken about often within underrepresented communities is trust. At the Biotechnology Innovation Organization’s recent annual conference, a panel spoke about boosting racial, ethnic and gender diversity in trials. They discussed the negative effects that non-diverse study populations could have, alongside the historical barriers that have led to feelings of mistrust among certain ethnic groups. To increase diversity, they stress the importance of ensuring investigators come from diverse backgrounds, to demonstrate cultural competency. Find out more here.
COVID-19 is taking an unequal toll on underrepresented communities
Recently, early research found dexamethasone reduced COVID-19 related deaths by one-third in ventilated patients. But, the study didn’t share information about the racial and ethnic background of participants. People are naturally concerned about this, since African Americans are known to respond differently to dexamethasone. There have since been rallying cries to ensure any further studies are inclusive and thoroughly test the drug among different ethnic groups. Take a closer look at more examples of the issues surrounding ethnic diversity in clinical trials, here.
Stress and ethnicity linked to Alzheimer’s
Although African Americans are afflicted with Alzheimer’s disease at higher rates than white people, and comprise ~13% of the US population, they represent less than 5% of drug trial participants. Vanderbilt University’s Renã A.S. Robinson notes: “This makes it hard to know if and how these potential therapies may work for Blacks and other underrepresented groups.” This article calls on the industry to commit to inclusion and equality in Alzheimer’s research and development to ensure these issues are addressed going forward. Read more here.
Is lack of reporting causing systemic bias within trials?
Within atrial fibrillation trials from 1996–2019, JACC: Clinical Electrophysiology has recently found that:
Only 2% of trial participants were African American, despite making up 13.4% of the US population in 2018
The participation rate for Hispanics was 5.6%, far lower than their 18.3% proportion of the American population
Asian individuals were overrepresented in trials compared with their proportions in US census data from 2010 and 2018
There’s a huge lack of reporting on the ethnicity of the participants.
Based on these findings, it’s suggested that clinical trial reporting should be standardised to avoid this ‘systemic bias’. Read more about the lack of reporting here.
Support for scientists
National Institute on Ageing (NIA) has spoken out on the disparities within underrepresented populations. In this article, they discuss:
Data collection strategies
Research programmes to support scientists.
The NIA has years of experience and are sharing resources and knowledge to minimise future effects of conditions like COVID-19 in American communities. You can find out more about their programmes and opportunities here.
Taking action: more diversity initiatives
Stand Up 2 Cancer (SU2C) has said all of their proposals will now incorporate a way to include and retain minorities within their trials. Sung Poblete, chief executive officer of SU2C, says it’s their ‘duty’ to ensure all communities have equal access to potentially life-saving treatments.
Ruben A. Mesa, MD, director of the Mays Cancer Center, has found Hispanics to be the largest minority group in the US (Texas) that:
Have differences in detection and treatment
Have a need for scientific advancement.
To tackle this, the centre has introduced community outreach and engagement that includes a committee to increase the number of Hispanic people who are recruited to clinical trials. Read more here.
There’s still a long way to go for patient diversity
The American Association of Kidney Patients has issued a statement discussing how African-Americans represent 32% of patients receiving dialysis treatment, yet are disproportionately included in related clinical trials.
Johnson & Johnson's Chief Communication Officer Michael Sneed echoes the sentiment of needing to do more for the black community, and explains how his organisation is aiming to deliver a vaccine on a not-for-profit basis. He also discusses the need for more women in trials, educating through the use of online communities and reducing racism through their Diversity & Inclusion Strategy.
This highlights the need for more diversity and inclusion in clinical trials, and while many are on the right path to taking action, there’s still a long way to go.