Jennifer A. Wenzel, PhD, RN, CCM, FAAN
Clinical trials that lack diversity can lead to ethical, as well as efficacy, issues, however. In an interview with Oncology Nursing News, Jennifer A. Wenzel, PhD, RN, CCM, FAAN, associate professor at Johns Hopkins University Schools of Nursing and of Medicine, explains what some of these barriers can look like, why diversity in trials is important, and how nurses can help encourage patients in minority populations to enroll in clinical trials.
Oncology Nursing News: What are some barriers to clinical trials that minority patients can experience?
Wenzel: There are certainly some barriers that affect a lot of people, issues like transportation or concern about income and perhaps the issue of being uninsured or underinsured. These are issues that cut across groups and, as with many things when we look at health disparities, they may impact minority populations more than other groups.
The issue of being mistrustful or warier of research can impact minority groups, specifically when we think about projects like Tuskegee where there have been egregious instances of research misconduct. We can see how that would impact certain groups more than others.
Another issue is how trials are communicated. We know that this is important, and we know that we're still struggling with challenges like cultural competence and communication bias, whether it’s overt or perhaps more implicit. How are clinical trials represented and are they represented at all to groups? One barrier might be that minority patients may hear less about clinical trials than other groups. Some of this comes from what we think of as a positive motivation—providers see a patient, and they make assumptions about protecting the patient and not creating what they might see as additional vulnerabilities for the patient, or complications related to their care. However, there are benefits to participating in trials.
Why is it important that clinical trials be diverse?
First, it's an issue of an essential ethical principle of justice. When we think about trials, some of our largest trials are funded through federal monies. We expect that these trials will be to benefit not just science but people. We want to make sure that those benefits are distributed equally.
To be able to generalize, from a scientific standpoint, these results to all groups, we must have representation from all groups. To be able to answer important questions about whether treatments, devices, or drugs impact some groups differently than others, we must have adequate sample size and representation so that we can make some subgroup analyses. We really have learned from some important missteps that not all groups respond to the same treatment, to the same drugs, to the same devices, in the same way.
How can nurses encourage patients from minority populations to enroll in the clinical trial?
Nurses may sometimes perceive more burden for patients. Better understanding of clinical trials, and the importance for patients of engaging in clinical trials, would help. Clinical trials do create some complexity on the front-end of treatment, there's no doubt about that, and even during treatment it may require some additional visits.
Particularly for minority patients, there may be concerns about the community at large and some of the disadvantages that they observe in the community. Many times there is an extra burden for them [minority patients], in terms of wanting to make sure that their experience does benefit other people from a community that they see as having been left behind.
In speaking with patients on this topic, there was a clear understanding that minorities have been left out many times in the past. We must make sure that we're focusing on inclusivity and making it possible for them to be not just invited, but to be successful in terms of being enrolled to clinical trials. That's an important step forward when we think about research ethics, when we think about equity, in terms of healthcare access.
Nurses have a lot of respect from patients. Nurses are perceived as having less at stake in terms of research trials, and nurse navigators may be perceived as someone who is particularly focused on the patient, and perhaps on the family. The family is another really important opportunity, and it's probably the area that we've researched the least when it comes to clinical trial recruitment and retention—how families are part of healthcare decisions and how they're critical to success.
You led a nurse/community health worker navigation intervention involving caregivers. Why is it important to educate the caregiver?
It is probably the next step for us, in our work at Hopkins, is to look at what we call decision partners. Decision partners might not be caregivers in the strictest sense. They were, though, sometimes the main drivers of the clinical trial decision. Patients, and particularly our minority patients, or seniors, have a lot of concerns about family burden. They may defer the decision about whether to participate in a clinical trial to their family, or to their decision partner.
In other words, if the decision partner, who is in many cases the least likely to be on board when it comes to clinical trial participation, is not excited about the opportunity, then the patient may perceive that the family has enough burden with the disease and the treatment and that participating in the trial will add too much burden, so the patient may decide not to participate in the trial.
In these circumstances, the patients were probably the most likely to regret that decision. On their own, they probably would have made the decision to participate. It's observed as a missed opportunity to leave behind an important legacy.
I mentioned that the decision partners are probably the most likely to be against the idea of participating in research. I think a lot of that is because we don't include them in the conversation. Everything they're hearing is secondhand. When you hear things secondhand, you don't have the opportunity to ask questions, and you don't have the opportunity to share what your reservations are and to see if those can be overcome.
What tips can you offer to nurses in smaller clinics and practices?
Nurses who work in smaller centers are extremely resourceful at helping patients. A lot of times in smaller centers, we don't always have the people to refer to. We become really savvy about what some of the internal and even some of the community-level resources are. There are opportunities; for example, if transportation is an issue, “here's how we might be able to address this. Here are some community level resources, for people of your age, or in your geographic location. Here are some center resources.”
When people have a diagnosis of cancer, sometimes patients and families are inundated with offers of help, but it's hard for them to identify where people can help them. Nurses and navigators can be helpful in tapping into some of those resources. There is a tendency toward independence, self-reliance, the important of autonomy, and self-regulation—managing things on your own—that can be a little counter-productive sometimes, during treatment.
That may also be a problem when we think about adding the complexities of participating in a clinical trial: We need to help patients and families, help decision partners realize that they’ll need support, at least as much as the patient does during this process. And they're probably the least likely to get assistance in our current healthcare system. Nurses can talk to them about how, in supporting the patient during treatment and trial participation, they’ll need some support as well. “What are your resources? How can we be helpful to you in this process?” Because the truth is, we depend on caregivers quite a lot. We are delegating a lot more responsibility… but we're not necessarily allocating more resources or support to them.
What policies might help to improve clinical trial recruitment?
When we think about advocating policies that are supportive, the truth is, research funding promotes good science, but with very strict budgets. And as we tighten those budgets, sometimes what really falls by the wayside are specific programs and interventions to make sure that our research populations are diverse. From a nursing perspective, from a research perspective, we can advocate for funding that really allows for a research plan and a research approach that will promote adequate representation in trials. It shouldn’t be an afterthought, but rather, a specific plan to ensure adequate enrollment and retention.