We’re all aware that clinical trials have been discussed more widely since the COVID-19 pandemic. While that’s a great thing for raising awareness of clinical trials in general, it’s also highlighted some pretty big issues in clinical research. For example, the world can see how the BAME community has been disproportionately affected by the coronavirus, which has also underlined how unrepresentative clinical trials are of them. And over the last few weeks, we’ve been looking at other populations who are also being left behind.
With June being PRIDE month, conversations were taking place around the world with regards to COVID-19, clinical trials and the LGBTQ+ community, and we were there to listen and collect important insights.
2. INTRODUCTION
June is PRIDE month around the world, and we have seen a range of discussions
online broaching the topic of COVID-19, clinical trials and more, within the Lesbian,
Gay, Bisexual, Transgender, Queer and others (LGBTQ+) community.
As clinical trials for COVID-19 have increasingly become a topic of conversation,
so has the scrutiny of clinical trials in terms of their effectiveness, accessibility and
how representative their study populations are.
In particular, LGBTQ+ people have faced a history of marginalisation in clinical trials,
leading to challenges and barriers that still deter them from taking part.
This Demand Diversity report highlights some of the key topics, articles and
conversations taking place online and issues that need to change within the
clinical trials industry.
3. SUMMARYOFKEYFINDINGS
– In the context of clinical trials, LGBTQ+ people are often associated with negative
medical preconceptions.
– COVID-19 has brought health inequalities to light, putting a strain on LGBTQ+ people’s
mental health and wellbeing.
– The guidance for blood and plasma donation hinders men’s ability to contribute to
clinical trials.
– COVID-19 treatment investigations have overlooked the needs of the LGBTQ+ community.
– Research has suggested depression, anxiety and suicide rates are higher in the LGBTQ+
community than in the heterosexual population1.
– Clinical trial researchers may be losing out on opportunities to test treatments for
sexual, ethnic and racial minority groups.
– Improving inclusivity and diversity in clinical trials continues to be a challenge as many
LGBTQ+ minority groups face discrimination.
4. TOPLEVELANALYSIS The countries leading the online conversations
were USA, UK, India, Canada and Israel.
An online sentiment analysis showed that only
2% of online content is positive, whereas 98% of
content is classed as either neutral or negative.
The most frequently occurring keywords
associated with terms like ‘LGBTQ+’ and ‘clinical
trials’ are predominantly negative and medical
terms:
– Undiagnosed HIV infection
– Heart disease risk
– Key evidence gaps
– Risk
– Donor eligibility
– Lifestyle factors (diet, alcohol, recent sex).
Search carried out in June 2020, for mentions between 1 January 2020 – 16 June 2020.
5. COVID-19HASBROUGHT
HEALTHINEQUALITIESTOLIGHT The widespread and global impact of COVID-19 has shown to disproportionately affect minority groups
such as BAME (black, Asian and minority ethnic) as well as marginalised or disadvantaged groups.
In the LGBTQ+ community, we’ve seen individuals face poorer health outcomes as a result of COVID-19.
Although there is no evidence to suggest that these people are inherently more likely to contract COVID-19
than other groups, the factors above may result in a higher risk of infection than the general population.
According to research from the LGBT Foundation2, LGBT people are:
Less likely
to access
healthcare
when they
need it
More likely
to be living
with HIV*
More likely to
be homeless
or insecurely
housed
More likely
to smoke
Less likely to
be physically
active or have
a good diet
*whilst not a risk factor, those with a low CD4 count are advised to follow additional protective measures
6. COVID-19HASBROUGHT
HEALTHINEQUALITIESTOLIGHT LGBTQ+ young people are more likely to be homeless,
meaning they’re more likely to be in poor health and less
able to access healthcare3. The pandemic has had a
profound impact on people’s
mental health and wellbeing
“I can’t be myself, I can’t come out &
is hurting inside. Prior to the covid19
crisis I was due to move out into
supported living where I can gain
access with my mental health but now
this lockdown I’m stuck in limbo”
“I am not out to my mum so having
her staying with me is rather a strain”
The rates of LGBT people unable to access healthcare
for non-COVID-19 related issues vary by demographics3:
16%
LGBT young people
18%
LGBT people aged 50+
22%
BAME LGBT people
26%
Disabled LGBT people
27%
Trans people
27%
Non-binary people
7. BLOODANDPLASMA
DONATIONGUIDANCE…
…restricts men who have sex with
men’s (MSM) ability to contribute to
clinical trials.
Traditionally, members of the
LGBTQ+ community have been seen
as hard-to-reach populations for
clinical trial recruitment4 due to
historical stigmatisation.
However, there were complaints
when COVID-19 clinical trial guidelines
demonstrated “archaic and
homophobic rules” preventing gay
and bisexual men from participating5.
In New York, restrictions have been
relaxed for gay and bisexual+ men to
donate blood and plasma samples, but
there is still a shortage that could help
develop treatments for the virus6.
8. REPRESENTATIONREMAINSUNEQUAL A major 2010 review of inclusion criteria in clinical trials indicated that exclusion of lesbians and gay men
from clinical trials in the US is not uncommon, particularly in studies with sexual function as an end point7.
Another longitudinal study found women were underrepresented in research in 7 out of the 11 disease
categories, even when women were more likely to have the disease8.
In April, US Senators urged CEOs of major pharmaceutical companies that any COVID-19 vaccine or drug
trial should include women, minorities, and LGBTQ+ persons9.
Treatments investigated for COVID-19 has raised further issues for LGBTQ+ people7:
As oestrogen and progesterone are often
used by transgender women, clinical trials
during a time when many trans people are
having trouble accessing health care, raise
even more concerns about access to
medically necessary treatments.
HIV medication was also authorised for
emergency use to treat suspected cases of
COVID-19 earlier this month.
9. INCLUSIVITYHASBEEN
PURSUEDSINCEAIDSEPIDEMIC
Two articles that raise historical issues stemming from HIV and AIDS clinical trials have had
significant reach with hundreds of views and shares online.
Varsity.co.uk
article11
– During the AIDS epidemic, advocates protested
against the drug development process and its strict
entry criteria for clinical trials as an unreasonable
barrier to participation.
– Tensions rose in 1990 when activists were not
involved in discussions regarding AIDS clinical trials.
– Eventually, HIV drug clinical trial requirements
were loosened so that more patients could try
new compounds.
– Excluding MSM from blood donation appears to be
driven by outdated ideas about gay men,
promiscuity and perversion.
– Italy and Spain have adopted donor policies based
on an individual assessment of sexual behaviours
during donor screening.
– On the other hand, the UK maintains a deferral
period of 3 months without sexual activity, perhaps
due to financial concerns or difficulties updating
donor screening policies.
Socialistaction.org
article10
10. CONCLUSION
Future implications
The COVID-19 pandemic has shown that
pharmaceutical companies must listen to the
key unmet needs of patients to help foster
connections beyond lockdown – for better
accessibility, relevance and engagement.
Consulting diverse groups (including
minorities from BAME and LGBTQ+ groups)
for development of exclusion criteria and
study designs will reduce alienation of
minority groups. In order to create safe and
effective treatments and vaccines, minority
groups must be included in trials.
What we have found
LGBTQ+ people still face discrimination and
stark health inequalities rooted in historical
preconceptions.
Improving inclusivity and diversity in
clinical trials continues to be a challenge,
as many LGBTQ+ minority groups are left
out or overlooked.
It is essential to recognise and address
the specific needs of LGBTQ+ communities
during, and beyond the pandemic.
11. REFERENCES
1. ABC News. Are Gay People Excluded from Clinical Trials?
https://abcnews.go.com/Health/WellnessNews/gay-people-
excluded-clinical-trials/story?id=10129927 [Accessed
June 2020].
2. LGBT Foundation. Why LGBT are Disproportionately Impacted
by COVID-19. https://lgbt.foundation/coronavirus/impact
[Accessed June 2020].
3. LGBT Foundation. 2020. Hidden Figures: LGBT Health
Inequalities in the UK. Available at: https://lgbt.
foundation/hiddenfigures [Accessed June 2020].
4. Browne JL, Rees CO, van Delden JJM, et al. The willingness to
participate in biomedical research involving human beings in
low- and middle-income countries: a systematic review. Trop
Med Int Health. 2019;24(3):264-279.
5. London News Online. South London leading the charge to
find coronavirus cures. https://londonnewsonline.co.uk/
south-london-leading-the-charge-to-find-coronavirus-cures/
[Accessed June 2020].
6. Refinery29. How Activists Are Creating A “Queer Response”
To The Coronavirus Pandemic. https://www.refinery29.com/
en-us/2020/05/9824007/LGBTQ+-coronavirus-activism-queer-
response-act-up [Accessed June 2020].
7. Egleston BL, Dunbrack RL Jr, Hall MJ. Clinical trials that
explicitly exclude gay and lesbian patients. N Engl J Med.
2010;362(11):1054-1055.
8. Centre for American Progress. What Women Need: An
Agenda to Move Women and Families Forward.
https://www.americanprogress.org/issues/women/news/2019/
12/04/478068/women-need-agenda-move-women-families-
forward/ [Accessed June 2020].
9. Bloomberg Law. Senators Say Minorities, Women Must Be Part
of Covid-19 Tests https://news.bloomberglaw.com/
coronavirus/senators-say-minorities-women-must-be-part-of-
covid-19-tests [Accessed June 2020].
10. Socialist Action. Dr. Anthony Fauci and the Gay Community:
Then and Now. https://socialistaction.org/2020/06/01/
dr-anthony-fauci-and-the-gay-community-then-and-now/
[Accessed June 2020].
11. Varsity. Gay blood is not dirty: Examining the science and
politics around MSM blood donation https://www.varsity.co.uk/
science/19221 [Accessed June 2020].
12. This report (including any attachments) has been prepared for the exclusive use and benefit of the addressee(s) and solely for the purpose
for which it is provided. All report information is correct as of June 2020. Unless COUCH Health provide prior written consent, no part of this
report should be reproduced, distributed or communicated to any third party. COUCH Health do not accept any liability if this report is used
for an alternative purpose from which it is intended, nor to any third party in respect of this report.
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