December 2022 • PharmaTimes Magazine • 10-11
// COVER STORY //
Minority report
Improving LGBTQ+ access to clinical trials and wider healthcare makes sense for everyone
Diversity and inclusion has been a hot topic in the clinical research industry for years. At its core, increasing diversity in clinical trials helps to ensure the safety and effectiveness of new medicines but, crucially, it can also help build awareness and trust in clinical research.
More work needs to be done to increase enrolment and retention of under-represented patient populations. These groups often do not participate in research due to a lack of awareness or trust, fear of being treated differently throughout the trial, or simply not having access to the means to participate.
Yet, change is underway. The FDA has advised sponsors in its 2022 guidance to ‘seek diversity in clinical trial enrolment beyond populations defined by race and ethnicity, including other underrepresented populations defined by demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status and comorbidity’.
Indeed, there is a key question being asked right now – is the LGBTQ+ community under-represented in clinical research? It is hard to say for certain as many studies don’t ask about sexual orientation or identity, however, their representation in trials is necessary and the community at large has been cited as a medically underserved group.
To ensure their participation in research, those who conduct clinical trials may benefit from having a deeper understanding of those identifying as LGBTQ+, including life experiences and health practices, but also potential participation blockers, such as inclusion or exclusion criteria and financial or logistical obstacles to ensuring access.
Understanding and outreach
The first step to ensuring LGBTQ+ individuals receive equal access to healthcare is being informed about this group. This starts with the most basic forms of healthcare, including doctor visits and preventive care visits.
According to research conducted by the Center for American Progress, a quarter of LGBTQ+ individuals who faced discrimination in the previous year postponed or avoided medical care due to the fear of further judgment. Respondents also reported they had to teach their providers about their community in order to get adequate treatment.
Doctors and other healthcare providers would benefit from having knowledge of common medical issues these individuals face and how to treat them – this can help to ensure a positive experience for patients, ultimately resulting in better data and medical advances for this population. After all, healthcare needs of the LGBTQ+ community go beyond HIV testing and prevention.
In fact, a survey of over 15,000 members of the community revealed that nearly half believed pharma companies aren’t doing enough outreach work or taking steps to understand members of the community.
They specifically noted that marketing tactics – such as brochures, commercials and billboards – do not portray homosexual couples or people who “look like them”. This can be alienating and, in the case of clinical trials, it can contribute to the misperception that they aren’t eligible to participate in studies.
Improving protocol development
Keeping all groups – regardless of race, gender or ethnicity – at the forefront of recruitment strategies, helps to ensure that diverse populations are aware of new medical research and that it is accessible to them.
For example, gathering community input on study protocols can help to ensure that clinical studies are successful and inclusive. It is in this pivotal study start-up phase that it is possible to elevate participants’ needs and, therefore, impact the study design.
‘A quarter of LGBTQ+ individuals who faced discrimination in the previous year postponed or avoided medical care due to the fear of further judgment’
In a paper published by the Fox Chase Center in Philadelphia, experts shared their concern that doctors could needlessly be excluding gay men and lesbians from clinical trials – which is avoidable if the necessary steps are taken. Accessibility considerations such as language on intake forms, strategies for outreach and financial reimbursements are all critical to improving LGBTQ+ participation.
Once enrolling, sites may also consider strategies for recruiting members of the LGBTQ+ community – whether it’s virtual engagements, such as posting ads on the web or in apps, or attending in-person events.
There are also organisations that provide dedicated services to ensure the inclusion of this population. These organisations assist in providing a safe space for individuals – giving them access to financial resources and multifaceted healthcare.
Engagement and retention
Considering the economic impact of trial participation is critical for all study participants, but especially this community. LGBTQ+ people collectively have a poverty rate of 21.6%, which is higher than the rate for straight people, which is 15.7%.
Additionally, one of the aspects that prevents people from participating in clinical trials is the time required to participate, which can require periods off work.
To reduce the burden on patients, the industry is increasingly offering patients flexible options, including the ability to complete activities from home via tools such as wearables and virtual doctor visits when possible.
Providing participants with these resources removes some of the logistical issues associated with getting to the clinic. Even if patients are not coming on-site for visits, however, it is important that participants are reimbursed.
Indeed, a Greenphire survey revealed that over 80% of 1,800 trial site personnel agreed that providing a small payment following a virtual visit would improve the likelihood of participants staying in a clinical trial.
Dangerous impacts of under-representation
When health surveys and research studies don’t include questions about sexual orientation and gender identity, it can make it difficult to analyse the magnitude of healthcare availability and potential gaps.
Taimur Khan, Associate Medical Research Director of The Fenway Institute at Fenway Health, recently spoke about the impact of exclusion. “The advancement and implementation of technology helps streamline the trial process to be more efficient for the sites and to be more user-friendly, which is of equal importance,” he explained.
He added: “Research is only applicable to the participants you have in the study. If a study is only looking at white cisgender gay men who have sex with other men, it is irresponsible to take this data and apply it to other patients outside of this group. It’s important for diversity to exist and offer the incentive for sponsors to make the data applicable to as many people as possible.”
To collect accurate data needed to foster medical advances, individuals from all different backgrounds must be represented – removing obstacles can help to ensure that broad participation.
Looking to the future, while the industry has made progress on the issues of diversity and inclusion, there is still work to be done. This all starts with being informed and showing understanding. When medical professionals and pharma companies have knowledge about selected populations such as this one, they are better able to communicate and provide a more comfortable experience for patients.
It is not a quick fix but showing genuine motivation to cultivate change increases the chances of building trust over time.
Jaleeysa King is a Data Delivery Analyst at Greenphire and Joshua McVoy is CRO Partner Manager at Greenphire. Go to greenphire.com