P107: Making an Inclusive Impact: Collecting Sexual Orientation and Gender Identity Demography in Clinical Trials
Patient Inclusion and Health Equity Intern
Genentech, A Member of the Roche Group United States
The objective of this initiative is to measure the LGBTQ+ community’s access to clinical trials and to better understand the health needs of the LGBTQ+ community by collecting sexual orientation and gender identity (SOGI) data of clinical trial participants.
LGBTQ+ health equity education for employees, rationale for collecting SOGI, and recommended terminology and protocol language were created and socialized with study teams. Study teams are piloting optional SOGI collection and any collected data will be anonymized and aggregated in the final report.
While it is known that members of the LGBTQ+ community are more likely than their cisgender-heterosexual counterparts to experience difficulty accessing health care, the extent of health disparities concerning LGBTQ+ individuals, including in most clinical trials, is primarily unknown due to a lack of data. The limited data that is currently available shows higher rates of certain malignancies including endometrial, anal, lung, prostate, cervical, and colorectal cancer in the LGBTQ+ community (Landers 2011). LGBTQ+ individuals also face higher rates of mental health conditions, and on average, die 12 years sooner in areas with high levels of anti-Sexual and Gender Minority (SGM) prejudice (Pérez-Stable 2016). In order to combat these health disparities, the first step is collecting data to see if the LGBTQ+ population is being reached and represented in clinical research.
To start this initiative, extensive research was undertaken to create a rationale for the collection of SOGI data. A list of recommended terms was generated using sources such as the NIH PhenX toolkit. The rationale and terms were presented to various leadership and study teams, resulting in two studies agreeing to pilot the collection of SOGI data in their trials. The rationale was also presented to a patient foundation, who subsequently launched a survey to collect SOGI data from their patients.
The ability of healthcare providers to address LGBTQ+ patients’ needs, and ease access to healthcare, starts with creating an environment that is both representative and inclusive of the LGBTQ+ community. LGBTQ+ patients have reported that they search for clues in environments to determine acceptance, such as self-reporting sections for sexual orientation and gender identity on intake forms. By allowing patients to voluntarily disclose this information, patients may feel safer with their healthcare provider, and the provider has more knowledge of their patients’ identity, and therefore, their health.
For clinicians to understand the safety and efficacy of an investigational product in all patients, clinical trials should have representative patient groups. Current data on race, ancestry, and sex assigned at birth shows that ethnic minorities and cis-gender women face larger health disparities than their white, cis-gender male counterparts. This data has allowed clinicians to create inclusive practices in clinical trial recruitment, along with tailoring treatments to groups that may be affected differently by certain diseases. If this data is not collected, healthcare settings are unable to measure the inclusivity of their research or understand how generalizable their clinical studies are. Unfortunately, data on the LGBTQ+ community is not currently collected in a vast majority of research settings.
Collecting SOGI data increases knowledge of health disparities in the LGBTQ+ community, and enables determination of whether such populations are excluded from clinical trials. This allows for measures to reach underrepresented communities, which will ultimately lead to higher quality clinical trials. It may also lead to the identification of patient sub-populations at increased risk of adverse events or differential efficacy.
When presenting the rationale for the collection of SOGI data, there was pushback. Not due to blatant homophobia, but rather, a lack of education on health disparities in the LGBTQ+ population. By not collecting SOGI data, we amplify this lack of awareness - creating an incomplete picture on the safety and efficacy of our drugs, and an incomplete picture of our patient population. By collecting SOGI, we can bring to light the challenges the LGBTQ+ community faces, and start to create solutions. SOGI data makes science and medicine more inclusive of all patients, regardless of who they are and who they love.
Additional Authors: Meghan McKenzie, Anagha Srirangam, and Shilpen Patel