Taking the US as an example, now 7.1% of the population identify as LGBT+, this has doubled since 2012 when it was reported as low as 3.1%. This demonstrates an increasing need to involve and improve LGBT+ representation in clinical studies.
In clinical research, and wider health, historically there have been inequalities and disparities faced by the LGBT+ community. These include a general underrepresentation in clinical research, poor data collection related to sexual orientation or gender identity, lack of transgender health understanding, and in some cases a reduced access to care. This has resulted in a limited understanding of LGBT+ health issues across medical research, and minimal evidence-based guidelines for addressing their specific healthcare needs.
I’ve focused on 5 strategies which trial sponsors can adopt to improve documented representation of LGBT+ patients in clinical research.
Trial sponsors should actively seek to include a diverse range of participants in clinical studies. To attract LGBT+ patients, recruitment efforts should ensure that advertisements, and promotional/ informational materials are inclusive and appear welcoming to LGBT+ individuals. This may include simple adaptations to imagery to represent single-sex couples or transgender pregnancies – as an example – or use of inclusive pronouns such as they/them.
Training & Education
Sites & Trial Sponsors should provide education and training to researchers about the unique health needs of LGBT+ individuals. By doing so this can create a culture of understanding amongst patient-facing trial operational staff, further leading to LGBT+ patients feeling more comfortable when in the clinical setting – improving the overall trial experience.
Data Collection, Reporting & Publication
When collecting patient screening data sponsors should include questions about sexual orientation, gender identity, and sex assigned at birth. Collecting this data can help identify areas where inequalities exist and inform targeted interventions. As an industry we should also encourage researchers to report and publish data of sexual orientation and gender identity. Without this data, it is hard to determine the exact representation of LGBT+ individuals in clinical studies, and where they are underrepresented.
Trial Design & Site Selection
When designing trials, it is key to consider the needs of all patient groups, including the LGBT+ community. This may require adapting study protocols, outcome measures, and interventions to address their specific concerns. It should also be advised to acknowledge the site location’s local laws on LGBT+ freedoms to ensure that patients are willing, and able to disclose their sexual orientation and gender identity.
Collaboration & Partnerships
By involving specific LGBT+ advocates and/or community groups trial sponsors can ensure that they actively involve the specific needs of the patient group in study design & patient recruitment outreach. As an example, Gilead Sciences partake in numerous partnerships to improve their outreach with the LGBT+ community. These include HIV support grants, HIV awareness campaigns, and Monkeypox education grants – all areas known to disproportionally effect the LGBT+ community.
Improving LGBT+ representation in clinical research is crucial to address the healthcare disparities faced by this community. By implementing inclusive recruitment practices, providing training and education, collecting and reporting data on sexual orientation and gender identity, considering the needs of LGBT+ individuals in trial design, and fostering collaboration and partnerships, trial sponsors can enhance the representation of LGBT+ patients in clinical studies.