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PM Live: July 2020: diversity and inclusion in clinical trials round-up

PM Live: July 2020: diversity and inclusion in clinical trials round-up

COVID-19 has continued to bring diversity and health inequality to the forefront of people’s attention. Our latest round-up covers the July news around these issues, and brings you the latest initiatives that are trying to create positive change.

Genentech make effort to boost diversity and inclusion in COVID-19 treatment studies

The COVID-19 pandemic has exposed even more evidence for health disparities among different ethnic groups. One of the main factors that influences health outcomes in these groups is a lack of access to and participation in clinical trials. In light of this, Genentech have highlighted how for a study on one of their treatments for patients with severe COVID-19 pneumonia, study sites were included that are at the intersection of COVID-19 hot spots and underrepresented populations. Genentech are also running the EMPACTA study, which will recruit patients from underserved communities.

Quita Highsmith, Genentech’s Chief Diversity Officer, gives three key recommendations to create more inclusive clinical trials:

  • Ask clinical trial site investigators to be intentional about recruiting diverse patients
  • Expand site networks to include potentially smaller, newer sites with more diverse catchment areas
  • Prepare guidance documents with clear expectations for internal teams and external partners.

The shocking stats surrounding black women and health outcomes

Alarmingly, although black women are overall less likely to develop breast cancer, they’re 40% more likely to die from it compared with white women. So why is this the case? This article reveals some of the wide-ranging reasons behind this disparity, including:

  • Black women are victims of sexism, prejudice and racism, which can affect all stages of the patient journey
  • Black women are underserved at every step of the diagnosis and treatment pathway
  • Black women are at higher risk for a type of triple-negative breast cancer, but are underrepresented in clinical trials.

Who can contribute to increasing diversity in clinical trials?

If you’ve read the content on our Demand Diversity website, you’ll know all about the issues surrounding diversity in clinical trials. But who can really help drive change in this area? Dr Loree (a medical oncologist and assistant professor at the University of British Columbia in Vancouver), told Medical News Today, “We need to listen to our patients and understand how they feel about research and the barriers each patient faces” and emphasised the importance of including the patient voice during study planning stages.

Rear Admiral (RADM) Richardae Araojo, (FDA Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity) stated that, “Site locations where there are more racial and ethnic minorities and diverse study team staff are also efforts that support recruiting minority populations.” She also noted that the FDA are continuing to recommend and work with study sponsors to increase diversity in their trial populations.

The conclusion was that a multisector approach, partnerships, patient engagement, HCP engagement and sharing best practices will all be vital if diversity is really going to increase in clinical trials.

Attitudes towards clinical trials vary based on race and gender

The results of SubjectWell’s recent survey revealed some key differences across different ethnic groups and gender about taking part in clinical trials, in the context of the COVID-19 pandemic.

On the whole, compared with Caucasian respondents, African American respondents had greater hesitations when considering participation in non-COVID-19 clinical trials and a greater desire for safety precautions if they did take part. Interestingly, 26% of African American respondents were not at all likely to consider taking part in a non-COVID-19 study, whereas this figure was much lower, at 13%, among Caucasians.

The survey also found that men were less reluctant about taking part in non-COVID-19 clinical trials than women, and women have a greater need for safety precautions if they took part.

Key steps to increase the participation of black women in clinical trials

This article discusses some of the barriers to black women participating in clinical trials, including unethical historical events, a lack of diversity among researchers, and the failure to ask black women to take part. But what can be done to recruit more black women to studies? Dr. Charlotte Owens, an OB-GYN and medical director of AbbVie, has completed successful clinical trials on uterine fibroids with a high representation of Black women, and outlines the key steps required:

  • Reach potential participants in places they trust
  • Ensure language and imagery used in marketing resonate with black women
  • Conduct trials at investigator sites close to their communities

Educate not only the patients about the trial, but their friends and families too.

How engaging target communities early can increase diversity and inclusion in clinical trials

Jocelyn Ashford, the director of patient advocacy at Eidos Therapeutics, a BridgeBio company, discusses here how community engagement can be a successful first step in reaching different ethnic groups. The benefits of this include:

  • Gain real insights instead of making assumptions about the recruitment plan
  • Hear concerns and attempt to address them
  • Educate those involved about the importance of trials and what they involve
  • Increase trust among different generations.


It’s not just patients and communities we need to engage with though, it’s study investigators, and site staff too. Unconscious bias and lack of cultural safety can hinder patient recruitment, so training programs should definitely be considered.

Older adults aren’t being represented in COVID-19 clinical trials

A study that aims to understand the implications of elderly underrepresentation in clinical trials has found that roughly 15% of clinical trials for COVID-19 systematically exclude adults between the ages of 65 and 80. While at first glance it might seem it’s safer not to include older people, this underrepresentation is actually making the situation worse.

Marina Martin, an assistant professor and section chief of Geriatric Medicine at Stanford Medicine, said “With vaccine research, if we only test a vaccine in a younger population, we run the risk of having a vaccine that doesn’t work on older adults. And then, the most vulnerable population will still be at an increased risk and will remain a group in which the virus can thrive and proliferate.”

This remains an issue for many indications, and the article states that steps can be taken to ensure study designs and recruitment strategies are more older-adult friendly. 

The patient experience and health outcomes of IBD vary with ethnicity

Although there’s been an increase of inflammatory bowel disease (IBD) in underrepresented populations, there are still lots of misconceptions surrounding Crohn’s and ulcerative colitis among certain ethnic groups. 

  1. Different ethnic groups are at risk of IBD. For example, ulcerative colitis is more common among Hispanics compared with non-Hispanic whites, and Crohn’s disease–related hospitalizations are increasing in Asians
  2. Health outcomes for IBD are poorer among African Americans vs white Americans
  3. In some cultures, an IBD diagnosis is associated with stigma, which can impact the patient journey
  4. Stress and depression can disproportionately affect minority groups, and these can impact IBD symptoms and management
  5. Traditional medicines may be favoured among some cultures.

Diversity and inclusion need to improve in cancer trials

We know that people of different ethnicities might respond differently to the same cancer treatment dose, based on their environment and genetics. In fact, there are examples among East Asians who experience high levels of toxicity vs Caucasians when being treated for head and neck cancers. The evidence shows that diversity in clinical trials, and a full understanding of the effects of treatments in all ethnicities really does matter.

Policies and practices of inclusion are one way that can help increase diversity in trial populations. One program managed to increase enrolment of black patients by over 60% through community engagement and cultural competence.

Making progress in the diversity of Alzheimer’s disease trials

According to the Alzheimer’s Association, black people are twice as likely to get Alzheimer’s disease, and Latinos are 1.5 times as likely. Plus, research shows that the pathophysiology of Alzheimer’s disease varies between African American and white individuals. So surely it is not right, that the majority of patients in Alzheimer’s disease trials over the past few decades, have all been white. In a positive step forward, the Global Alzheimer’s Platform Foundation expects that at least 20% of estimated recruits for a biomarker trial will be Black and Latino, and that the study will not close until a minimum of 200 black and Latinx people are enrolled.

Stand Up To Cancer announces new efforts to combat health inequity

Black people are among those who typically suffer poorer health outcomes from lung cancer. With this in mind, Stand Up To Cancer announced a new $5 million grant from Bristol Myers Squibb to fund research and education efforts to help improve health equality among underserved lung cancer patients. Early next year, a Stand Up To Cancer Innovation Summit will launch the project, which will bring together lung cancer experts with researchers specializing in health equity and access.

Sung Poblete, PhD, RN, CEO of Stand Up To Cancer, said “This is the type of commitment and collaboration needed to ensure all cancer patients benefit equally from advances in research and treatment.”

We’re glad to see that Stand Up To Cancer is collaborating with advocacy and community-based organisations, such as the Black Women’s Health Imperative and Friends of Cancer Research. This will massively help improve trust while educating people on the importance of cancer clinical trials.

Recommendations to ensure all women are included in COVID-19 research

As we all know, a large number of clinical trials are already underway to develop treatments and vaccines for COVID-19. And with these developments, there is now an opportunity to address the prior exclusion of women from clinical trials, particularly non-white women.

This new report explains the historical and ongoing exclusion of women in research and the negative impacts this is continuing to have. It also provides recommendations to try and overcome these issues, such as encouraging researchers to engage in targeted outreach.…