MimiVax, Inc. is developing immunotherapeutic vaccines and targeted therapies for treating cancers and preventing recurrence. The company’s lead agent, SurVaxM, targets survivin, a cell-survival protein expressed in cancer cells.

Read more in Nature BioPharma Dealmakers

In 2021/2022, 3.3% of the UK population identified as lesbian, gay or bisexual, 0.5% identified as transgender and 0.06% identified as non-binary. Globally, up to 1.7% of the population is intersex. Despite these numbers, there is a lack of research into how treatments affect people across the spectrum of sexuality and gender, and this has potential to put people from these communities at risk.
 
Diversity in clinical research is vital in order to ensure that the study results are relevant to as broad a population as possible, and this includes involving people from LGBTQIA+ communities. Accessing the widest possible population will also allow companies to recruit enough people for studies, and therefore move drugs through the development process more quickly, speeding up the time it takes to get to market and into the hands of patients. Improving the inclusivity of clinical research will help everyone to gain equitable access to the most effective and safest forms of treatment.
 
Barriers to taking part in clinical trials
For LGBTQIA+ people, a range of barriers can contribute to making clinical research a less viable option for them.
 
Loss of trust
Many people from the LGBTQIA+ community have had poor experience(s) when accessing and experiencing healthcare. Negative experiences can fuel mis- and dis-trust of healthcare both as a system and the healthcare professionals that work within it. These experiences are highly likely to likely to impact willingness to take part in clinical trials.
 
From a Stonewall survey:

• One in eight LGBTQIA+ people (13%) have experienced some form of unequal treatment from healthcare staff because of their gender or sexuality
  • This includes one-third of trans people, one third of lesbians, one in five LGBTQIA+ disabled people and one in five ethnically minoritised LGBTQIA+ people
• One in four LGBTQIA+ people (23%) have witnessed discriminatory or negative remarks against LGBTQIA+ people by healthcare staff
• One in four LGBTQIA+ people (25%) have experienced inappropriate curiosity from healthcare staff because of their gender or sexuality
  • This includes half of trans people and more than a third of non-binary people
• One in five LGBTQIA+ people (19%) aren’t out to any healthcare professional about their sexual orientation when seeking general medical care.
  • This includes 40% of bi men and 29% of bi women
• One in ten LGBTQIA+ people (10%) have been outed without their consent by healthcare staff in front of other staff or patients
  • This includes 27% of trans people and 15% of LGBTQIA+ disabled people
• One in twenty LGBTQIA+ people (5%) have been pressured to access services to question or change their sexual orientation when accessing healthcare services
  • This includes 20% of trans people, 9% of LGBTQ+ young adults, 9% of ethnically minoritised LGBTQIA+ people and 8% of LGBTQIA+ disabled people
• One in six trans people (16%) have been refused healthcare
• One in seven LGBTQIA+ people (14%) have avoided treatment for fear of discrimination
  • This includes 37% of trans people and 33% of non-binary people

 
Other issues include:

• Going to see a doctor can mean having to explain sexuality or gender identity from scratch each time, and when appointment times are limited, this reduces the time available to discuss medical issues.
• Medical records that include only male/female options result in misgendering for trans and non-binary people, and making them feel othered by the system.

  
The impact of gender and sexuality
The barriers already discussed show why LGBTQIA+ people overall may be less likely to accept or interact with medical interventions. It goes further, though – the impact of gender and sexuality on healthcare is complex, and it crosses biology, neurodiversity, culture, sociology and current and past medical interactions.
 
These are a few examples:

• Intersex people may have physical and hormonal characteristics that interact with medical interventions.
• A proportion of trans and non-binary people are on hormone therapy, and this can affect how their bodies react to various medications, as well as potentially changing their risk factors to hormone-linked diseases. As an example, a study in HIV-positive transwomen showed that their hormone therapy interacted with antiretroviral therapy in a way that could make it less effective.
• Neurodiversity is more common in the LGBTQIA+ community than in cisgender heterosexual people. While older studies suggested that autism make people less sensitive to pain, recent studies suggest that autistic people actually experience pain at a higher intensity than the general population, are less able to adapt to the sensation, and are more likely to have higher levels of pain-related anxiety. These findings could have an impact on current study outcomes, and also how we read older studies.

 
Access to clinical trials
People in the LGBTQIA+ community are more likely to be unemployed, work part-time, or have a lower-paid job. This has an impact on whether they can afford to travel to clinical trial sites or take time off for clinic visits.
 
Neurodiversity comes with issues of sensory overload and difficulties in processing or remembering information, all of which make the unfamiliarity of a clinical trial site harder to navigate.
 
Binary inclusion/exclusion criteria can also reduce the ability of trans and non-binary people to take part in clinical trials. Some clinical trials also actively exclude gay men and lesbians.
 
Building better clinical trials
Making changes improve access for LGBTQIA+ people to clinical trials. One key change is queering the language. Talking about studies using the binary terms men and women can exclude trans, non-binary and intersex people. Changing the wording, for example from men to people with a prostate or from women to people with ovaries, isn’t about erasing men and women and the language associated with them, it’s about being specific and accurate with the language that we use. This will broaden the population of people who see that they are able to participate, and make the results more applicable to the general population.
 
As an example, contraception wording in informed consent forms is often tailored towards heterosexual cisgender couples:

​Some studies do need exclusion criteria, for example if hormone treatments cause drug-drug interactions with the study drug. In this case, the protocol should be worded to exclude the treatments and not the groups of people.
 
Other changes, some of which are simple and low or no cost, could make major differences to the inclusivity of a study:
 

• Build trust
• Train staff on equality, diversity and accessibility, and make sure that they understand that discrimination will not be tolerated
• Include LGBTQIA+ individuals and groups when designing clinical trials, including how to remove barriers and eliminate bias, and the best way to collect data on gender and sexuality
• Ensure that people are reimbursed for travel or missed work
• Ask about sex assigned at birth as well as gender identity, and allow participants to self-describe using their own terminology and language
• Ensure that records are kept and that staff read them before clinic visits, to avoid explanations, outing and misgendering at future visits
• Include appropriate gender options on forms, including free-text space where possible
• Provide changing rooms and toilets with gender-neutral options
• If overnight stays are required, provide single rooms rather than male/female dorms
• Include pronouns on staff name badges, and ask for participant pronouns as standard procedure
• Provide images or video as well as text instructions for access to the clinical trial location
• Ensure that people are followed up and thanked
• Seek and incorporate feedback from LGBTQIA+ people and trial participants
• Support LGBTQIA+ staff as well as patients

 
By involving more LGBTQIA+ people in studies and making them welcome, companies developing new drugs can improve the diversity of their clinical trials and improve access to drugs for all.

To learn more about why diversity in clinical research is so important, read my piece on Pharma Sources.
 
With thanks to Heidi Green, Director of Health Research Equity, Chloe Stephenson, Research and Insights Manager, and all of the rest of the COUCH Health team
 

Randomised controlled trials (RCTs), where study participants are randomly allocated to an experimental group or a control group, became the 'gold standard' of clinical research in the mid-20th century. [1] RCTs have historically enrolled proportionally more white men than people from other groups, with the thinking, at least in part, being that the results could be extrapolated to all populations. Subsequent research, however, has shown that this is not the case, as underrepresented groups may have different responses to the disease or drug, based on social, cultural and other contexts. [2] Diversity in clinical trials, which is about so much more than differences in biology, is therefore an essential part of ensuring that everyone has equitable access to the most effective and safest approaches to treatment. 
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Read more at Pharma Sources.

Read the article here.

Read the article here.

In 2015, at the United Nations Climate Change Conference (COP21), 196 countries adopted the Paris Agreement to limit global warming to no more than 1.5 °C. This requires countries to cut emissions by at least 45% compared with 2010 levels, and reach net zero by 2050. However, the current commitments from this coalition of countries fall far short; based on current plans, rather than falling, emissions will increase by almost 30% by 2030. It's vital that companies, as well as governments, get behind the goal of net zero as soon as possible.

​Read more at Pharma Sources.