September 2020: diversity and inclusion in clinical trials round-up
Our latest round-up takes a closer look at the different conditions where health disparities are present, such as more women living with multiple sclerosis (MS), and the cancer death rate being highest among Black people vs all other ethnic groups. Plus, there are a couple of articles with important insights about inequalities in LGBTQ+ communities, too.
A crisis of mistrust patients among Black, Latinx, LGBTQ+ and low socioeconomic backgrounds
A recent study by Genentech aimed to get to the heart of the patient experience by interviewing over 2000 patients about their interactions with the healthcare system. Disappointingly but unsurprisingly, mistrust was very prevalent among Black, Latinx and LGBTQ+ patients, alongside those with a low socioeconomic status. The initial findings from the interviews with these patients include:
While approximately half of the US general population feels all patients are treated fairly and equally, only 27% Black, 27% Latinx, 34% LGBTQ+, 23% low socioeconomic agree that all patients are treated fairly.
Patients in these groups believe the system is not just flawed — but that it is actively out to get them.
About half of these patients have stopped seeking care or skipped follow-up appointments due to fears that they were misunderstood
Roughly 1 in 3 don’t participate in clinical trials, get vaccinated or get tested for conditions due to lack of trust.
The Hispanic population is underrepresented in lung cancer trials despite experiencing different health outcomes to white people
In a recent commentary in JCO Global Oncology, authors outlined the lung cancer disparities in Hispanics, both in and outside the US. Some of the key findings were:
In the US, the incidence of lung cancer is 39.2 per 100,000 for Hispanic males and 24.6 per 100,000 for Hispanic females. Mortality from tobacco-related cancers among migrants is higher among Mexican Americans because of a higher smoking prevalence.
EGFR mutation frequencies vary in LATAM countries, and studies have suggested that somatic mutation frequency in EGFR in lung cancer could be associated with genetic ancestry.
The Hispanic population is generally not represented in lung cancer trials because of limited access and few research centres.
“If you see the major immunotherapy trials published, there are few Hispanics or Blacks included in the US trials, despite the fact that together they are close to 30% of the population. There is the same problem in Europe.” Luis E. Raez, MD, of Memorial Cancer Institute/Florida International University in Miami, one of the co-authors.
Addressing the issues facing LGBTQ+ patients in healthcare
Improving diversity in clinical trials and equality across healthcare isn’t just about ethnicity. The LGBTQ+ community has also long been medically underserved and misunderstood. The disparities experienced by these patients can negatively impact health outcomes, especially in cancer care.
Moffitt Cancer Center is launching a study to help change this, and the study will inform the COLORS Training Program, which has been designed to help oncologists better understand the unique challenges facing this patient population. In the future, the training will be made available to all medical oncologists for continuing medical education and adapted for additional health care professionals, such as nurses and physician assistants.
It’s great to see the centre using real insights to inform the training, and this will undoubtedly go on to positively change the care that LGBTQ+ patients receive.
Lack of awareness of clinical trials is a barrier faced by Hispanic people with Parkinson’s disease
A recent study looked into the barriers to participation in clinical trials faced by Hispanic people who have Parkinson’s disease.
"The three most common were lack of the awareness of the research, lack of awareness of [the] disease, and financial issues," Shakeel Tabish, MD, reported in his online presentation at the 2020 Movement Disorders Society virtual congress.
These findings show that there is still much more work to be done in improving awareness and knowledge of clinical trials for Parkinson’s disease, especially among the Hispanic community.
Acknowledging, exploring and overcoming the underrepresentation of Black scientists
The exclusion of Black scientists from institutions, the failure to recognise contributions of Black scientists, and the lack of culturally relevant scientific curricula all contribute to the underrepresentation of Black people in science today. This article in the Harvard Business Review outlines 4 steps that need to be taken to bring about positive change:
Acknowledge the problems that exist – the underrepresentation of Black scientists within STEM.
Find out why these problems exist – this includes identifying unconscious bias that inhibits leaders from selecting Black scientists to join their labs, or the misconception that Black researchers aren’t interested in scientific work, only diversity.
Test and design solutions to these problems – encourage conversations about race, ensure people in science undertake cultural safety training, provide guidance to be self-critical and overcome unconscious bias, partner with Black scientists on research work, and more.
Evaluate the success of these solutions and use them to shape organisations.
A new focus on recruiting ethnic minority patients for a major COVID-19 trial
To increase the recruitment of Black and Asian people, and those from other minority ethnic groups, a pharmacist, Mahendra Patel, has joined the PRINCIPLE trial in a new role. The trial is taking place in the UK, led by the University of Oxford. It aims to find treatments for COVID-19 that are suitable for patients aged over 50, and that can be taken at home and therefore reduce the need for patients to go to hospital.
To date, almost 1000 people have volunteered to take part, but the university said that “recruiting people from Black, Asian and minority ethnic communities has been a particular challenge.” This is particularly problematic, as people from these communities are known to be at a higher risk of becoming seriously ill as a result of COVID-19.
Patel will work to widen access to the trial among people from different ethnic minority backgrounds.
Black people still experience the highest death rates of any ethnic group, despite rates falling overall
According to data from the National Cancer Institute, cancer death rates have been falling overall since 2000, and the gap between racial and ethnic groups has been narrowing. But, Black Americans still have the highest death rate from cancer vs all other ethnic groups. And although it’s thought these disparities can be explained by socioeconomic factors, no one can be certain why Black people are still underrepresented in clinical trials.
The American Association for Cancer Research (AACR) recently issued its first annual cancer disparities progress report, intended to be a "baseline" for watching trends.
According to Antoni Ribas, president of AACR, "AACR is also extremely concerned that racial and ethnic minorities continue to be underrepresented in cancer research and clinical trials, especially because the different ages, races and ethnicities may respond differently to cancer treatments.”
Ribas says AACR has formed a task force to call on policymakers and stakeholders to work on concrete actions to alleviate cancer disparities.
Ways to improve diversity and patient centricity in clinical trials
Improving diversity and patient engagement within clinical trials is gaining more attention than ever before. But what can be done to drive these changes? This article suggests some key factors:
Continue to ensure strong doctor-patient relationships, even amid the pandemic
Improve the informed consent process
Give patients the choice about in-person or remote visits
Let patients decide if they can self-administer the study drug, where appropriate
Understand that people have different abilities with using technology – some people might need more training and support with technology used in a clinical trial
Consider housing instability and the impact on trial participation
Recognise that patients have lives outside of their condition – from family/care responsibilities, to careers, to finance.
The common theme is that the patient voice needs to be considered when making any changes to how clinical trials are carried out. Shifting to virtual healthcare requires focus, transparency, and an integrated approach across all stakeholders, including patients and caregivers.
Why we still don’t know the reasons behind more women living with MS than men
While it’s been observed for a long time that more women are affected by MS than men, no one knows why. According to Riley Bove, MD, assistant professor of neurology at the UCSF Weill Institute for Neurosciences, one of the reasons for this lack of understanding is lack of statistical power in clinical trials.
Different studies have to enrol different numbers of men and women to either be representative of the population living with MS (3:1 female to male), or to look at an effect on MS progression (1:1 female to male). For example, if you have a lower percentage of men in a trial, the study may not be adequately powered statistically to find a statistical difference or statistical impact. So, attention also has to be placed on whether the studies are powered statistically to find the differences that you expect.
Dr Bove also states that the data from interventional clinical trials doesn’t tell us enough about how women and men may respond differently to treatments. So, it’ll be really important to ensure trials are statistically powered to investigate this in the future.
There has been an explosion of content written highlighting the inequities in clinical trial participation, we can't unfortunately feature all of the articles, so highly recommend you read the below articles.
If you would like any of your articles featured in the next round-up, email us at firstname.lastname@example.org