Blog 4 minute read

Sexual Orientation and Gender Identity in Clinical Trials: Why the Data Matters

Sexual orientation and gender identity (SOGI) are important social determinants of health that can significantly impact health outcomes. However, historically, clinical trials have not adequately accounted for these factors. Thus leading to a lack of representation and exclusion of marginalized populations. This exclusion has resulted in health disparities that are often perpetuated by inadequate data and lack of access to healthcare.

LGBTQIA+ Inclusion in clinical trials

Diversity and inclusion in clinical trials is essential for ensuring that medical advancements are accessible and effective for everyone. Failure to consider SOGI in clinical trials means that treatments may be developed and approved without adequate knowledge of how they may impact individuals who identify as LGBTQIA+. This lack of information can lead to serious health risks, including ineffective treatments, missed diagnoses, and adverse reactions.

The impact of exclusion

Studies show that the exclusion of LGBTQIA+ individuals from clinical trials can lead to significant health disparities. For example, a study by the National Institutes of Health (NIH) found that transgender individuals who receive hormone therapy are at a higher risk of developing heart disease, diabetes, and osteoporosis than cisgender individuals. Without data on the specific health needs of transgender individuals, healthcare providers may not be able to provide adequate care.

Clinical Trial Diversity and Inclusion

In addition to sexual orientation and gender, social determinants of health such as race, ethnicity, and socioeconomic status also play a significant role in health outcomes. The COVID-19 pandemic has highlighted the health disparities faced by marginalized populations, including LGBTQIA+ individuals. In a recent study, LGBTQIA+ individuals were found to be at a higher risk of contracting and dying from COVID-19. This is due to a range of social determinants of health, including poverty, housing insecurity, and lack of access to healthcare.

The impact of SOGI and DEI initiatives

In addition to improving health outcomes, including sexual orientation and gender in clinical trials also has broader societal implications. It sends a message to LGBTQ+ individuals that their health matters and that they are valued members of society. This can help to combat the discrimination and stigma that LGBTQ+ individuals often face in healthcare and society at large.

The current state of DE&I in clinical trials

There are some initiatives already in place to improve DE&I in clinical trials. For example, the FDA has established guidelines for the inclusion of women and minorities in clinical trials. And there is ongoing advocacy to expand these guidelines to include sexual orientation and gender identity. Additionally, some organizations are working to ensure that clinical trial protocols are inclusive of diverse populations. Such as the Patient-Centered Outcomes Research Institute (PCORI), which prioritizes research that involves patients and community members in the research process.

However, there is still much work to be done to ensure that clinical trials are truly inclusive and representative. This requires a commitment from researchers, funders, and regulatory bodies to prioritize DE&I in clinical trials. It also requires a shift in mindset to recognize that inclusion is not just a matter of social justice, but also critical for advancing medical knowledge and improving health outcomes for everyone.

Datacubed Health’s commitment

At Datacubed Health, we are committed to fostering an inclusive, supporting, and diverse work environment and clinical trial experience. We recognize that our role is specific to technology in clinical trials, but technology can also play a vital role in improving DE&I. For example, studies have shown that decentralized clinical trial models, improve underserved communities’ access to clinical trials. Additionally, our app has proven to be considered a “safe digital space” through our intentional design geared toward inclusivity. While there’s still work to be done, especially when it comes to SOGI data collection and consideration, we’re finally on the right path forward. Connect with us to learn more about our DE&I initiatives and how we can help you gather the right data, at the right time.