Lack of health data on LGBTQ+ people has real-world consequences. A participant in a 2020 report from the National LGBT Cancer Network said: “There are no guidelines for cancers that are more prevalent among Trans women. I had to fight like hell to have an anoscopy, and sure enough we found [precancerous lesions]!”
That same year, the National Academies of Sciences, Engineering, and Medicine issued a hallmark report on the health and well-being of LGBTQ+ people. It found that social and structural stigma has contributed to lower rates of engagement with the health care system (such as preventative screenings), higher rates of uninsurance and under-insurance, higher rates of many risk factors including smoking and obesity, higher rates of some cancers and cardiovascular disease, and higher rates of mental health challenges including depression, anxiety, addiction and suicidality.
As a result, it encouraged public and private entities, including the pharmaceutical industry, to include LGBTQ+ data in “all data collection efforts and instruments.” Since then, the White House, a perspective piece in the New England Journal of Medicine, and others have called for broader collection of LGBTQ+ health data.
Yet so far, the pharmaceutical industry has fallen short. In recent years, it has seen promising efforts to address race and ethnicity as a key element of diversifying clinical trials. Now, that work must also include LGBTQ+ populations. It’s time to start normalizing the collection of sexual orientation, gender identity, and intersex status as standard patient demographic/characteristic data.
There is a classic chicken-and-egg dynamic at play when it comes to addressing LGBTQ+ health disparities: Without a strong body of research describing the nature and causes of health disparities for the community, most health care stakeholders are unaware of the gaps that exist and the relative lack of data. And since most stakeholders are unaware, they don’t appreciate or understand the need for LGBTQ+ measures in more research. Until recently, there has been very little quantitative research about the lived experiences of sexual and gender diverse populations.
This is not just a moral issue of equality. The relatively limited body of health data on the LGBTQ+ community makes it clear that the population faces significant disparities.
LGBTQ+ patients often cycle through many providers looking for one that is affirming and knowledgeable, all the while delaying care and putting off treatment. Anyone who has worked with these patients has heard countless such stories, sometimes leading to poor health consequences.
Numerous studies have shown very high patient willingness to provide their LGBTQ+ data in the health care setting: in the community and outpatient clinics, in the emergency room, and even among oncology patients and veterans.
Yet they rarely get an opportunity to share that information, because the questions often go unasked. Standard demographic data collected today include age, biological sex (sex assigned at birth), race and ethnicity, socioeconomic status, geographic location, medical history, smoking status and alcohol use, and pregnancy status. To bridge the vast data gap among LGBTQ+ patients, pharmaceutical companies need to ask questions about sexual orientation, gender identity, and intersex status.
Not collecting this information prevents us from seeing to what extent the LGBTQ+ community participates in our studies and whether these patients experience different outcomes. For example, data show that lung cancer is more frequent among LGBTQ+ patients (perhaps due to smoking rates). However, without collecting sexual orientation, gender identity, and intersex status data in clinical trials, the industry has no way of knowing whether its study population is adequately representative of the underlying lung cancer patient population along these dimensions, nor can it detect differences in how these patients fare.
It also misses the chance to gather relevant information that could inform health care provider-patient discussions about risk factors, treatment options, care support networks, and desired treatment outcomes as well as epidemiologic. In addition, respectfully learning about these patient characteristics sets a powerful example for health care providers who should want to know their patient as fully as possible so that together, they can navigate the patient’s lived experience. Research suggests that sexual orientation disclosure itself may lead to more positive direct and indirect health outcomes.
One way health care stakeholders can advance diversity in research while protecting privacy is by allowing all research participants to self-identify their LGBTQ+ characteristics through an electronic device in a private setting. At Bristol Myers Squibb, where I work, we are implementing this in clinical trials across therapeutic areas for U.S. adult trial participants.
We have also trained training major electronic clinical outcome assessment (eCOA) vendors on collecting LGBTQ+ data utilizing their platforms. eCOA platforms intelligently automate capturing patients’ experiences through robust and reliable electronic measures, providing real-time insights that inform trial progress and demonstrate results. So, having an eCOA vendor include LGBTQ+ characteristic questions as part of its assessment tool will help capture critical LGBTQ+ patient experience data electronically, and importantly, do so in a way that enables patients to privately consider whether they want to disclose this information.
Still more needs to be done throughout the industry. All entities conducting clinical research need to examine their study designs to ensure they are not unnecessarily restrictive against LGBTQ+ patients, patients on HIV medication, or those on hormone therapy. More research needs to be done to understand how transgender patients can be safely included in studies, for those studies where hormone levels may have an impact.
These interventions need to happen industrywide to be effective and achieve true, equitable health. It requires collaboration across all who play a role in the clinical trial process: pharmaceutical companies, contract research organizations, trial sites, health authorities, providers, and patients.
Paul Shay is executive director, portfolio strategy, within the WW Commercial Portfolio Strategy group at Bristol Myers Squibb and was most recently the global lead for the company’s PRIDE Alliance People and Business Resource Group for LGBTQI+ colleagues and allies.