Building Inclusive Clinical Trials: Strategies to Include the LGBTQIA+ Community
As we consider the strides made in awareness and visibility through Pride Month, we look at our own arena, healthcare, and see a much different picture. The Lesbian, Gay, Bisexual, Transgender, Intersex, Queer and/or Questioning, and Asexual and/or Ally (LGBTQIA+) community and other underserved populations face unique health challenges, such as lesser access to health care, and often pay the price with poorer health throughout their lives.
Existing research suggests LGBTQIA+ people and families face challenges associated with access to preventative care, diagnosis, and treatment leading to health disparities. (1). The limited data available suggests that:
- These barriers make the LGBTQIA+ community more prone to breast cancer. (4)
- Lesbian and bisexual women get less routine care than other women, including breast and cervical cancer screening. (1)
- Approximately 30% of LGBTQIA+ youth report having been physically abused by family members because of their sexual orientation or gender identity or expression.(1)
As a result, many members of the community choose to avoid health care, including clinical trials, or receive sub-standard care, due to societal stigma and discrimination by health care providers and organizations (1). Inaccessibility; inadequate engagement; lack of information about clinical trials and comfort with the research process; time and resource constraints associated with participation; and limited awareness of clinical trials are all factors that play their part too.
In addition to experiencing stigma, discrimination, and a denial of civil and human rights, many members of the LGBTQIA+ community are simply omitted from clinical trials. And when it comes to testing new drugs, therapies, and devices, there is a huge lack of needed diversity in clinical trials. For example, a study of 243 clinical trials related to couples and sexual function after various medical treatments showed that 37 trials explicitly excluded people in same-sex relationships, according to the New England Journal of Medicine. (2)
In addition, after the FDA and NIH invested $273M in 14 different centers, the centers published 71 research manuscripts on vulnerable populations. How many included mention of LGBTQIA+ persons? Two. If those other studies had simply asked if their participants were LGBTQIA+, they could have done an analysis of how our communities were affected and reported the results in all the manuscripts. (3)
Think about this, too: the U.S. is investing billions of dollars in cancer clinical trials, and simply because it is not yet standard to ask if a participant is LGBTQIA+, we know nothing about the rates of participation or particular different risks or health outcomes that are experienced by the community.
In addition, the NIH has been running a $100M initiative to expand diversity in its investigator pool. Thus far, the focus has been on racial and ethnic diversity. The office leading this effort recently conducted a workforce climate survey of NIH employees, where it asked about LGBTQIA+ status. What were the topline findings? The results show that the groups experiencing the most sexual harassment (by far) were trans people and bi women. (3) Finally, when researchers at NYU recently asked oncologists about their level of education in treating LGBTQIA+ patients, they found that 60% of oncologists did not feel they knew enough about treating LGB people, and 80% did not feel they knew enough about treating trans people. (3)
It’s clear that there is a problem. So what can be done?
Engagement, Trust, and Communication within the LGBTQIA+ Community
For Cedric Pulliam, Ph.D., a senior public health advisor at the Centers for Disease Control and Prevention — and a member of the black queer community — engagement, trust, and communication are essential to the entire clinical trial process. And community strategy groups are key to building this much-needed trust and engagement.(2)
“Every clinical trial should begin with this type of strategy group,” he explains. “The purpose of the group is to help clinical trial developers and staff gather community input to develop protocols, which will ultimately ensure a successful and inclusive clinical study.”(2)
He adds, “It’s all about the lived experience. Trial recruits need to see how the clinical trial is representative of their personal lifestyle. They need to be involved on the very first day—all the way until the very last day. It’s really about inclusion and giving everyone a voice. The idea of ‘can’t do this for us without us’ sums it up.”(2)
When explaining the need to take trial participants into consideration, Pulliam offers an example of today’s LGBTQIA+ youth. “There is a very high rate of homelessness within the LGBTQIA+ youth population,” he explains. “This high rate is typically due to family conflict, violence, neglect, abandonment, and a lack of acceptance. As a result, when these youth are included in clinical trials, the homeless scenario must be factored in to help develop successful recruitment practices, communication methods, logistics, and incentives for the trial.” (2)
In addition to organizing a strategy group, health professionals who run clinical trials must have an understanding of the LGBTQIA+ community, including pronoun use, life experiences, and health practices.“Many individuals avoid trials because health care providers don’t have the education or understanding needed to work with this population,” says Pulliam. “However, it means a great deal when doctors show they really care and want to learn. Doctors who give patients the time of day, as well as genuinely care about their lives, are a rare find.” (2)
Efforts must be made to understand LGBTQIA+ health practices and improve access to quality healthcare for the entire LGBTQIA+ community. Additionally, it is vital to develop clinical trials and therapies within a diverse patient population. “While this issue is acute in several clinical trial arenas, nowhere is it more so in the sometimes-underserved LGBTQIA+ population,” explains Katie Dry, a research physical therapist with the Military Health System via the Geneva Foundation.
“Individuals might not seek healthcare because they do not feel like they are going to be treated equally. If you are not creating a culture that is inclusive and educated, people are not seeking care. It’s incumbent upon the clinical trial industry to build as broad a tent as possible.”(2)
And there are numerous ways to build this broad tent. As part of their guidance on improving the diversity of clinical trials, designing inclusive trials, and overcoming recruiting barriers, the FDA provides a list of important and useful recommendations here.
While efforts to advance the diversity of clinical trial populations and to expand the inclusion of underrepresented populations in research studies often focus on race and ethnicity, we should also be addressing the systemic issues that have prevented the development of comprehensive health information about the LGBTQIA+ community.
Minor changes to clinical protocols, informed consent documents, and data collection forms can have a tremendous impact on both allowing the analysis of data in a way that allows us to better understand and treat the health care needs of this community and can make studies more welcoming and inclusive so that persons who are part of the LGTBQIA+ community feel comfortable and safe in participating.
Our Center for Diversity in Clinical Trials makes clinical research more accessible to underserved populations to enable faster enrollment, better retention, and more representative of real-world populations. Learn more here.