Clinical trial teams frequently endeavor to recruit a sufficiently diverse, representative patient population. However, various surveys and studies indicate that hiring an inclusive study staff can be helpful, too. A recent survey by Penn Medicine indicates patients typically feel more comfortable when interacting with medical personnel of the same background.
Liz Beatty, chief strategy officer of Inato, connected with Outsourcing-Pharma on the importance of tackling site staff inclusivity, and how a workforce that resembles a patient population can lead to a range of benefits.
OSP: Conversations about trial inclusivity/diversity usually focus on patients—could you please tell us a bit about the aspects of trials they’re usually centered on?
LB: Diversity focuses on many things - race, ethnicity, gender, socioeconomic factors - but ultimately, it all ties back to access. We need to remove the many barriers currently preventing underserved populations from participating in research in order to truly solve the problem.
It’s well known across the industry that a person’s physiology can impact how they respond to treatments. Yet, many clinical trials are still falling short of enrolling patient segments that are representative of the disease. This is very concerning as it means the treatments being sent to market are not proven to be safe or effective for all patients. It needs to change.
OSP: What among those characteristics typically get missed?
LB: When thinking about inclusive research, everyone talks about race and ethnicity, but socioeconomics is a critical piece of access and currently, it’s a huge problem. For example, most cancer clinical trials require the patient to still pay for standard of care, and marketed oncology medicines are very expensive, so in the US, if you don’t have insurance, or good enough insurance, affording that standard of care could be a problem. There are plenty of programs available to help, but to ask someone to navigate applying for financial support while also deciding about participating in a clinical trial … it’s almost insurmountable.
Clinical trials also require a time commitment and it can be difficult for people with lower socioeconomic statuses to miss work. For hourly workers or people who don’t get many days off, participating in a trial means they aren’t getting paid for the time spent at required trial visits. That’s a huge problem. It forces a choice between providing for themselves and their families or participating in a trial. That needs to change.
OSP: How have trial professionals evolved on bringing in people who look more like their patient populations?
LB: Having doctors who speak the same language as their patients is a critical part of inclusivity. It makes people more comfortable and ensures that they are fully informed about what it means to participate in the trial. If you’re looking to engage with Hispanic patients but don’t have any doctors who speak Spanish, you’re going to have a very hard time building trust and ensuring that people and their families understand the decision to join a trial.
However, in talking with community sites, we’ve learned that it’s not just about the doctors. Research nurses and study coordinators play a critical role in making people feel comfortable. They spend so much time building relationships with and developing trust, all that helps break down barriers.
OSP: How might having a more representational workforce in clinical research be beneficial?
LB: When research staff members are involved in the community, it builds trust and long-term relationships with people, which are essential to enrollment. Having a staff that is representative of that community also gives you meaningful insights into how people in that community are learning about trials and research. You don’t have to try to retrofit a solution when the staff members are genuinely engaged and know how that community receives and responds to information related to their health.
OSP: Could you talk about some of the pressures/motivations to bring in an inclusive staff—sponsor, sites, social, etc.?
LB: The main pressure is the science and maintaining data integrity, and now that is being followed up by the FDA and health authorities. It’s critical to understand how a treatment works in all populations, especially those most impacted by the disease.
The US population is highly diverse, including people from a wide variety of genetic heritages and backgrounds. It’s critical to make sure everyone can confidently take necessary medications, knowing that they have been properly tested.
That knowledge coupled with the FDA and health authorities further cracking down and, in some cases, mandating black-box warnings, requires that you have a plan. If a medication has a black-box warning for a population that was not included in the trial, then doctors will not prescribe the medicine to those patients and insurance won’t cover it. This can drastically limit the number of people who will take it, and who could benefit from the new medicine.
Limiting access to new treatments also hurts the pharmaceutical company’s bottom line. The FDA can also require the companies to run post-approval trials to make up for gaps in the original data. These are very costly - it puts a different level of motivation behind inclusive research.
OSP: What are some of the obstacles in recruiting a diverse study staff?
LB: Having diverse study staff is directly related to the fact that minorities in research staff are also minorities when it comes to graduating from medical and nursing schools. According to the Association of American Medical Colleges, across the medical school graduates in 2018-2019, 54.6% were White, 21.6% were Asian, 6.2% were Black or African American, and 5.3% were Hispanic, Latino, or of Spanish origin.
Nursing isn’t any better. According to the American Association of Colleges of Nursing, a 2017 study found that the RN population breaks down to 80.8% White, 6.2% African American, 7.5% Asian, and 5.3% Hispanic.
When the number of minority doctors and nurses is already low, the number who go on to participate in research is naturally going to be even lower. And then those doctors and nurses need to be working at facilities that offer clinical trials. There are so many compounding factors.
OSP: We spoke about efforts to recruit a more representative patient population (engaging the physicians that care for them, for example. Can you talk about some of the efforts you’ve seen to recruit a more representative staff?
LB: Some pharmaceutical companies are helping students of color through medical school. However, there’s still no guarantee that once they graduate, they’ll be interested in research. These plans take many years to play out and unfortunately, have no guarantee of success directly related to clinical trials.
Another option a lot of pharmaceutical companies have been using is forging partnerships with national associations focused on increasing representation in medicine. These associations commonly work to educate existing doctors and nurses on the importance of research and hope to inspire them to participate in it.
By approaching it from both angles and reaching out to both students and people who are already doctors and nurses, they may be able to make better progress.
OSP: What new approaches can you think of that the clinical trial industry might try to boost their representation?
LB: It’s critical to bring research into the community. We have to move away from the large academic centers that pharmaceutical companies have relied on for so long and give community-based research sites an equal chance to be selected.
When a site is embedded in a community, it’s more likely to have representational staff. Even if the doctor isn’t a person of color or minority, if they live in an area with diverse populations, then they can hire staff that reflects the community they serve. This also provides deep connections and insights into those populations and the best ways to build trust and get them engaged with research.
Additionally, by bringing the trials to the patients in their own towns, we can address a lot of the socioeconomic barriers that exist today. People don’t have to travel long distances or take full days off work when the site is nearby. Those sites are also more likely to already have grants established to help support the people they serve. These community sites already know the barriers that exist for their patients and have programs set up to address them - after-hours appointments, childcare, travel support, food, stipends, etc.
OSP: Is this something the industry might forge partnerships with other stakeholders to improve?
LB: Absolutely; pharmaceutical companies should build partnerships with national associations for clinical trial awareness to build a truly representative future for clinical trials. There are many associations that represent the clinical trial community, running the gamut from people who work in trials to the patients.
It’s essential to engage everyone to create inclusive trials at all levels because that’s how you move the needle. If we had more diversity within the pharma companies, we’d have more people saying, “This isn’t right. We need more people who look like me.”