Steps Toward Diversity in Clinical Trials: Building Authentic Trust

While neither the lack of diversity in clinical research nor the need for patient centricity is new, recently, the clinical research community has been more determined than ever to ensure that we take steps now to increase both in the most impactful, effective way possible. But while many voices are in agreement that this drive is necessary—and, indeed, achievable—questions still remain, such as: How do we actually start creating those meaningful conversations?

In the summer of 2020, as the COVID-19 pandemic continued to spread, Leland Allen, MD, of St. Vincent’s Ascension, rapidly enrolled more than 200 diverse (including Black and Latino) patients in a coronavirus trial. What is important about this? He did this in Birmingham, Alabama…right in the vicinity of the infamous Tuskegee trials that are often implicated as the very catalyst that drove a destructive wedge between the Black community and researchers that has persisted for decades.

The secret? Trust. As a respected, connected member of the Birmingham community, Allen has invested time and effort in building a solid, authentic foundation of trust within the area. When he teamed with Elligo Health Research, a healthcare-enabling organization that connects patients with clinical research through their trusted care providers, patients had very little hesitation participating in a trial for
COVID-19 research.

“There is nothing more important in the doctor and patient relationship than trust,” says Allen. “And that’s not just in the context of clinical trials. It’s in everything we do. If a patient or the patient’s family doesn’t trust the provider, or they don’t trust the information from the provider, they’re never going to ‘buy in’ to the treatment or medical advice.”

Building trust takes time, patience, and the willingness to be humble and open. But there are no shortcuts if researchers truly want to be part of the change that will ultimately increase diversity in clinical research in a way that is sustaining and authentic. Building trust includes the following steps.

Showing your worthiness of patients’ trust

The first step is taking an honest look in the mirror and examining your own behavior. “Obviously, if you have time to build a personal relationship with a patient, that’s best,” says Allen. “Then they recognize that you’re always honest and true to your word, and that trust grows. But sometimes you don’t have that opportunity. In that case, you need to convey to the patient that you are really interested in them as a person, and not just as someone with a disease or an illness.”

Even if there is bad news involved, Allen urges full transparency. “No one wants to hear bad news,” he says. “But everyone wants to hear the truth. If you’re trying to soften the blow and aren’t completely honest, that will backfire on you, because eventually the patient will figure it out. Then their thought process will be, if that doctor wasn’t honest with me, what else is he not going to be honest about? And especially when it comes to asking them to participate in research, they will have no desire to trust you or
your peers.”

Examining yourself first

Being willing to be vulnerable yourself increases the likelihood that you will better connect with patients in a manner that exudes trustworthiness. That means asking yourself, “Am I truly doing everything I can to be worthy of a patient’s trust?” To help achieve that, paired with honesty, be sure to stay in “continually learning” mode so you are making your decisions with absolute confidence and assurance.

“Especially in clinical research, our knowledge and understanding changes all the time,” says Allen. “The amount of information we have available to us increases exponentially. So, even if everyone is being honest and forthright in how we report data, and the way we conduct clinical trials, we need to be sure to have a healthy degree of suspicion to keep learning and studying and asking questions ourselves, to be sure we’re giving the right advice and doing the right thing with each and every patient.”

Working collectively

Beyond individual efforts, building trust as an organization is paramount. Establishing an institutional reputation that endures and spreads in the community comes from creating a culture that carries enormous value. “Not only have I personally tried to establish relationships to build trust, but my hospital itself, St. Vincent’s Ascension, is the oldest hospital in the city,” Allen says. “We have a long track record in Birmingham. That’s why it’s important to do your best for every patient, because word gets around, and that hospital’s reputation can last for a very long time.”

Leading by example to establish that culture is the only way to make that happen, Allen says. And having that trustworthy reputation builds on itself. “Institutions tend to coalesce around a particular set of values,” he says. “If an institution focuses on trust and value above all, then it identifies and selects doctors and nurses and other staff who share their values. And that set of values acts as a screen to ensure that everyone in that organization is aligned. That’s part of the reason why I’m at St. Vincent’s. Because I believe in what they do and how they do it.”

Communicating often and directly

“Depending where you are in the United States, the climate may be different between researchers and diverse communities,” Allen says. “Here in Birmingham, we have to overcome deeply rooted racial divisions because of events that happened before many of us here were even alive.” But he believes that honest communication will help play a major role in rebuilding trust. “We need to acknowledge the past honestly, while still saying, ‘This is what we’re going to do—today—to protect you, and here is how you will benefit in being part of this study,’” he says. “And hopefully, because they trust you, they will have some faith and courage to step forward with you.”

In addition to direct communication, addressing language barriers plays a tremendous role, as well. Allen recently had a very sick patient who didn’t speak English. “His son didn’t speak English either,” he says. “Our discussion was through the patient’s niece, who was on the other end of a phone call, and while it was better than nothing, it was not optimal. So, I could walk in and smile, but that doesn’t convey nearly as much information as a direct conversation.” Including diverse researchers within your organization can help create a more solid bridge to trust to help minimize language barriers.

Building trust not only will help facilitate increased trial diversity, but in the process of working to establish that trust, it will organically create patient-centric relationships—and patient-centric trials—at the same time in a very authentic, collaborative way. Ultimately, this will pay off by paving the way to a more connected, healthier global community across a diverse range of populations.

Faith Holmes, MD, Medical Director, VP of Medical Affairs, Elligo Health Research