October 2020: diversity and inclusion in clinical trials round-up
In our latest round-up of news surrounding diversity and inclusion in clinical trials, we take a closer look into the benefits that diversity can bring to society, learnings that we can take from the COVID-19 pandemic to shift our thinking around diversity and clinical trials, how we can address long-standing barriers to build trust in healthcare, and much more.
The good that diversity brings
Did you know that being around people who are different from us makes us more creative, more diligent, and more hardworking?
This comes from decades of research that shows socially diverse groups (those with a diversity of race, ethnicity, gender and sexual orientation) are more innovative than homogenous groups.
While research shows that social diversity in a group can cause discomfort, rougher interactions, a lack of trust, greater perceived interpersonal conflict, lower communication, less cohesion, more concern about disrespect, and other problems… overall, diversity is definitely beneficial.
For example, diversity:
Encourages the search for novel information and perspectives, leading to better decision making and problem solving
Improves the bottom line of companies, leading to new discoveries and breakthrough innovations
To further understand the benefits of social diversity — including examples and research studies that truly prove this acknowledgement — read the full article below.
A common diabetes medication is less effective in Black patients
Researchers at Boston Medical Center have brought to light a recent discovery: a common medication that is used to treat diabetic macular oedema, which is the most common cause of blindness in people with diabetes, is less effective when used to treat Black patients vs white patients.
According to their study, Black patients were significantly less likely than white patients to show short-term visual improvement after being given bevacizumab (Avastin), a common treatment used in the U.S. for diabetic macular oedema.
After one injection: 26.71% percent of Black patients, 39.39% percent of Hispanic patients, and 50% of White patients experienced improved visual acuity.
For those who received three injections: 33.82% of Black patients, 54.76% of Hispanic patients and 58.54% of white patients experienced improvements in their visual acuity.
This is the first study looking at race as a factor in the treatment of diabetic macular oedema. The results show that there is a clear need to increase diversity in clinical trial participation for the treatment of diabetic macular oedema, to develop treatments that are effective for all patients.
A shifting, yet familiar story of health disparities
In this blog, we get an inside perspective from Joseph R. Betancourt, MD, MPH, who led the combined Mass General Brigham and Equity COVID Response efforts at Massachusetts General Hospital (MGH) when the pandemic hit.
He explains how he, and many hospitals around the world, quickly learned that:
People with chronic conditions such as diabetes, lung disease, and heart disease, and those of advanced age, had a poorer prognosis once infected with COVID-19
In the U.S., these chronic conditions disproportionately affect minority populations, meaning minorities entered the pandemic with health disparities that put them at a disadvantage
With structural racism, discrimination, and the negative impact of the social determinants of health, the health and wellbeing of these communities are continuously undermined
Effective public health messaging, especially in minority communities where there is lack of trust, was not available.
Joseph believes that the narrative around health disparities needs to be shifted, and ends the blog with a key takeaway regarding what we have learned so far about who is at highest risk for COVID-19:
“It’s those who live in densely populated areas; those who have multiple and multigenerational households in small living spaces; those deemed essential workers — health care support services, food services, and more — who don’t have the luxury to work from home, have groceries delivered, or socially isolate themselves; and those who depend on public transportation to get to work, and thus can’t travel safely in their car, or afford parking when they get to work.
Minorities aren’t more genetically susceptible to COVID-19. Instead, all of the factors described here are the social conditions in which minorities and vulnerable communities are more likely to live and move around in this world every day. Only by building from this understanding can we hope to shift the narrative, and change the headlines before cases surge this winter.”
What are the barriers to greater participation of Black people in COVID-19 trials?
Concerns are increasing about the low rates of trial participation in important subgroups, including Black communities. But what are the reasons behind this lack of participation and what can we do to address them?
This article outlines that while there are many barriers, a critical factor is the deep and justified lack of trust that many Black Americans have in the general healthcare system and clinical research; this is often traced to the legacy of the infamous syphilis study at Tuskegee.
Addressing such a factor can be difficult. And of course, it would be wrong and ineffective to ask Black communities to simply be more trusting. Clinicians, investigators, and pharmaceutical companies must provide evidence (that is sufficient to overcome the extensive historical evidence to the contrary) that they are trustworthy.
The article outlines what we can do to earn and deserve increased trust:
Trial sponsors and regulatory agencies can ensure that the informed consent process is exemplary
Ensure that black communities will have fair access to vaccines once they become available — the recent guidelines from the National Academy of Sciences are notable in this regard, recommending that priority be given to “people who are considered to be the most disadvantaged or the worst off”
Honour the pledge to not submit a vaccine for approval until it has been thoroughly vetted for safety and efficacy
Ensure that prospective trial participants will receive appropriate medical care if they are injured as a result of receiving an experimental vaccine.
To find out more, read the full article here.
A chance to improve diversity in clinical trials, not just for vaccines
This article raises a very important point: that the COVID-19 pandemic can be used as a moment to improve diversity in clinical trials as a whole, and not just for vaccines.
Belen Garijo, member of the management of the Merck KGaA and CEO of Healthcare, explains that the problem of homogeneity among clinical trial participants is not exclusive to COVID-19. In fact, it is an industry-wide issue, and as such, it demands an industry-wide call to action.
She explains three key ways we can continue to evolve clinical trials:
Ensure that all treatments are being specifically tested for effectiveness among the populations that are most seriously affected by the disease
Ensure that treatments for diseases which afflict a diverse population are being tested among clinical trial participants whose diversity closely matches that of the populations being affected
Continue to invest in community education and outreach, especially within populations which have historically been underrepresented in clinical trials.
Get more insights and read the full article now.
Disparities in sickle cell disease
Globally, sickle cell disease is among the most common genetic disorders and predominantly affects individuals from African, Mediterranean, Arabian, and Indian origins. It’s been found that the implementation of newborn screening, infection prevention, and better coordination of care have led to improved survival. Yet, disparities between countries exist: over 95% of those born in high-income countries survive into adulthood, whereas fewer than 50% of children in low-income settings reach their tenth birthday.
Why do these disparities exist?
In low-income countries, particularly those in sub-Saharan Africa, there are no national coordinated strategies for management, including newborn screening and comprehensive clinics. In such settings, specialised sickle cell disease services and treatment is often inaccessible or unaffordable
In many African countries, cultural concepts of illness and health such as supernatural beliefs, stigma, as well as the inaccessibility of health-care facilities for people in remote settings, might encourage some parents to accept traditional remedies for their children instead of hospital treatment
In the U.S., fewer healthcare providers have training, knowledge, and expertise in management of pain and complications associated with sickle cell disease compared with other chronic diseases. As a result, adolescents and young adults with sickle cell disease in the U.S. have worse health outcomes than those with conditions predominantly affecting white people
When Africans migrate to high-income countries, they typically encounter stigma because of differences in culture, beliefs, and healing practices, which influence their openness to available treatments.
Overall, this article highlights that collaborative patient engagement and partnership in decision making about treatments need to be consistent among providers. Read the full article to find out more.
Superbloom: A new social media platform for women’s health
Did you know it’s estimated that more than 80% of women will experience at least one chronic illness in their lifetime?
Living with a chronic illness can be challenging. And that’s why Erin Berman, a former content strategist and brand designer for Silicon Valley startups and multinational corporation, has recently launched Superbloom.
The new social media platform aims to provide a space for women with chronic illnesses to connect with one another, features resources that are searchable by symptom, diagnosis, or treatment, and offers support channels designed especially for the millions of women currently living with the kinds of illnesses that evade proper diagnosis and treatment.
“We made Superbloom for women because we are so underserved by the medical community and the system of white supremacy, oppression and patriarchy that has traditionally dominated healthcare,” she explains.
Underrepresentation in cancer clinical trials
In an effort to explore the age and race distribution of patients within oncology clinical trials, a study looked into phase 3 clinical trials that had been conducted within the past 10 years. The age and race distribution of the patient population in these trials were extracted and analysed.
The main findings were:
Geriatric patients and minorities are underrepresented in all phase III cancer clinical trials
The range of the proportion of geriatric patients varied from 10% to 40%
African American and Asian patients are underrepresented in all phase III cancer clinical trials.
The results show that these phase III clinical trials may not be meaningfully applicable to geriatric and minority patients.
So, how can we be sure that the treatment will work for everyone? This study highlights the need for more diversity in clinical trials.