Meaningful inclusion of LGBT+ patients: what can Pharma do?

In respect of Pride Month 2025, Olivia Kersey, Patient Affairs Consultant and ISPEP Managing Editor, outlines how Pharma can better support the LGBT+ community through trial design and more.

Why are we talking about this?

People who identify as LGBT+ (lesbian, gay, bisexual, trans, and more) experience numerous health inequalities, e.g., regarding rates of certain health conditions, provision of relevant health information, and exclusion from research participation. It is therefore important from a human and social justice perspective that these issues are addressed.

This also matters from an industry perspective – for Pharma, failure to meet the needs of LGBT+ communities compromises trial data representativeness and accuracy of interpretation, as well as perpetuating mistrust in the industry and the likelihood of physicians not feeling confident enough to prescribe a given treatment to a patient identifying as LGBT+.

As LGBT+ visibility and advocacy continues, the number of publications demonstrating

1) physicians’ knowledge gaps regarding treatment of LGBT+ people and 2) damning statistics on industry inclusion (damaging trust in / reputations of pharmaceutical companies) will continue to increase. 

It is also true that compared to decades gone by, huge progress has been made with regards to many (but not all) aspects of LGBT+ inclusion in society and across the pharmaceutical industry. Every year during Pride Month, we see pharma companies’ social media channels fill with Pride flags and celebration of LGBT+ employees. Some companies will promote their awards won for fostering an inclusive working environment or company culture, and others will provide grants to patient/healthcare organisations to support external LGBT+ health initiatives. This progress represents a much more positive foundation than we had many years ago.

However, while it is indeed a mark of progress to see these demonstrations of support, we are not yet aligning actions with current needs; ultimately, it's the fundamental advancement of pharmaceutical practice itself that will have a meaningful impact. As a medical scientist, patient-focused drug development specialist, and proud bi woman, I am confident that there are opportunities to cut through the rhetoric and evolve our industry towards a more inclusive future – and not just during Pride Month!

Before we begin, a quick note on the sensitivity in the US regarding diversity, equity, and inclusion (DEI). Navigating those challenges is beyond the scope of this article, but I strongly encourage any ISPEPers with experience and expertise advocating for and executing DEI practices in the present US political climate to share their insights and tips in the comments section below.

Access to trials is a health equity issue

Access to clinical trials means access to novel potential therapies. Therefore, access to trials is a health equity matter; for many, trial participation could be their only chance of obtaining effective treatment. However, for LGBT+ people, there are numerous barriers to trial participation, including obstacles rooted in how the trials are designed.

Firstly, eligibility criteria; historically, people in same-sex relationships have been excluded from trials, as revealed in a Letter to the Editor published in the New England Journal of Medicine (no prizes for anticipating the reputational challenge a publication like this brings for Pharma!). It's important that inclusion of transgender people is also clearly accommodated for within trial protocols, analysis plans, data collection forms and more, including for those relating to treatments associated with a particular sex.

Without such measures, pharmaceutical companies risk generating trial data which:

1. Fails to be representative of the LGBT+ community, who are not only a huge worldwide population but also experience numerous relevant health intersections. When data are skewed away from a given population, informed clinical decision-making and chances of positive patient outcomes are compromised.

   
   

2. Is at risk of flawed interpretation due to insufficient contextualisation. For example, this can be due to the influence of sex and gender-affirming hormonal therapies on pharmacokinetics (drug processing) and biological reference ranges.

   
   

Thankfully, progress is being made with regards to scientific/clinical navigation of the biological complexities brought by physical gender transition (e.g., interpreting blood test data). From a technical perspective, this makes LGBT+ inclusion in trial protocols easier than ever before.

Focusing again on transgender people, pharma companies should also ensure trial documents are structured in an accommodating fashion. Current templates often fail to capture nuances such as gender vs sex and preferred name vs legal name, which are crucial distinctions for the trans community.

Even answering the seemingly basic question of whether one is male or female can be complicated for trans patients. For example, for someone who was assigned male at birth but takes feminising hormones, has had gender-affirming surgery, and is legally registered as female, declaring themselves as “male” or “female” with no further context is not straightforward. This is not simply a matter of inclusive language; as mentioned previously, accurate capture of both sex and gender, as well as relevant gender-affirming therapy history, is essential for informed interpretation of study data.

Finally, contraception and pregnancy tests are often core requirements of trial participation. However, it may not be clear for various communities, including people in female same-sex relationships and transgender men, whether they are included in this requirement. A lack of clarity here could ‘put off’ or even exclude LGBT+ participants very early in the trial recruitment process. Naturally, this is unlikely to foster trust in the industry.

In summary, there are fundamental aspects of clinical trial design which pharmaceutical companies must address (in collaboration with relevant patient advocates) in order to meaningfully include the LGBT+ community in clinical development programs. Without these changes, pharmaceutical companies face numerous risks, both scientific and social. 

From clinical trials to clinical practice and engagement to education: providing equitable, person-centred care

Of course, there is more to inclusion than trial design. Being a member of the LGBT+ community can have a profound impact on experiences of and trust in healthcare; further, members of this community may experience particular nuances relating to certain medical conditions (e.g., reproductive disorders, certain cancers, and more). Accommodating such factors is key to providing holistic care and facilitating informed shared decision-making. With such accommodation, the chances of optimal patient outcomes are greater.

Engaging LGBT+ patient advocates to understand their communities' unmet needs is vital to alleviate the relevant health inequalities. An example of meaningful outputs here could be co-created, inclusive patient and HCP education materials. Organisations such as OUTpatients, the UK’s only charity dedicated to LGBT+ people with cancer, can provide crucial insights to ensure materials are relevant

to – and therefore useful and effective for – LGBT+ patients.

What can you do?

Here are a few quick tips to get started:

1. Certify that you and your trial design colleagues are trained on evolving guidance and best practices for developing inclusive studies. Update templates for study protocols and accompanying documents accordingly.

   
   

2. Ensure patient information sheets and informed consent forms:

   
   

   • Explain why sexuality or gender identity data is being collected and how it will be protected.

     
     

   • Clarify contraceptive and pregnancy testing requirements across genders, removing these where possible to accommodate nuances regarding sexuality and gender identity.

     
     

   • Are reviewed by a diverse panel of patient representatives – and that any feedback regarding inclusive language or design elements is carried forward to future trials.

     
     

3. Consider whether information materials you develop are inclusive and consult advocates with relevant lived experience to ensure this is done optimally. Even if you are part of the LGBT+ community yourself, other members may have very different views or experiences to your own, so it is key to not make assumptions as to needs and preferences.

   
   

   

   
   

Closing sentiments

True patient-focused practice includes all ‘types’ of patients. This inclusion must be active – inaction is not neutral; it allows health inequalities to flourish. Active inclusion via fundamental changes to practice is essential for making a meaningful difference.

I would love to hear your thoughts and tips on LGBT+ inclusion in the comments section below (you are also welcome to reach out privately via oliviakersey@ispephub.org if preferred).

Here are some starters to get the cogs turning...

• What meaningful changes do you think Pharma can make?

• How can patient organisations offer insight?

• Do you know of any relevant case studies or outstanding initiatives?

  
  

Together, we can make a real difference. Thank you for reading.

Further reading

• Making clinical research inclusive: strategies to include the LGBTQIA+ community in research trials (McNair, 2021) N.B., this article has great examples of inclusive language regarding contraception requirements.

  
  

• Creating welcoming and affirming clinical studies for LGBTQIA+ participants toolkit (The Fenway Institute, 2025)

  
  

• Considerations for LGBTQ+ Inclusion in Clinical Research (Teckro, 2022)

  
  

• Diversity, equity, and inclusion in clinical trials: A practical guide from the perspective of a trial sponsor (Versavel et al., 2023)

  
  

• Improving access for and experience of transgender and non-binary patients in clinical research: insights from a transgender patient focus group and targeted literature reviews (Round et al., 2023)

  
  

• Guidance for developing and submitting an inclusion and diversity plan: second draft (HRA and MHRA, 2025)