Amy Niles on Underrepresented Communities in Clinical Trials

Author(s): Scott Douglas Jacobsen

Publication (Outlet/Website): The Good Men Project

Publication Date (yyyy/mm/dd): 2024/11/21

 Amy Niles is a dedicated healthcare executive with over 30 years of experience in nonprofit leadership, strategy, and public health advocacy. As PAN’s Chief Mission Officer, she drives education initiatives, advocacy strategies, and public policy efforts. In 2013, she developed PAN’s national advocacy platform, positioning the organization as a trusted resource for policymakers. Passionate about patient access to care, she has also led successful healthcare startups and serves on the Specialty Pharmacy Certification Board and advisory boards. Niles discusses the importance of increasing participation in clinical trials, particularly from underrepresented communities like people of color, LGBTQIA+, and men. Niles emphasizes the need for education and communication between healthcare providers and patients to foster trust and encourage participation in these vital studies for advancing medical science.

Scott Douglas Jacobsen: Today, we are joined by Amy Niles from the PAN Foundation. It’s important to begin by defining key terms clearly. Here’s a question: How would you differentiate clinical trials from other trials, particularly within healthcare?

Amy Niles: To help people better understand what we’re discussing today, we are focusing on encouraging participation in clinical trials for diseases and conditions that affect many individuals and specific medications. We don’t want to see trials conducted with limited representation from certain communities, followed by broad generalizations about the effectiveness of medications or treatments. This approach can lead to an incomplete understanding of the impact, particularly on underrepresented groups like men, the LGBTQIA+ community, and others. Historically, many participants in clinical trials have likely come from backgrounds similar to mine—middle-aged or older—which skews the statistical outcomes of the research.

As you mentioned, this doesn’t make the results as generalizable across the entire population as we would hope. The sample is often not representative of the general population. To advance medical knowledge and ensure real progress, it is essential that as many communities as possible are represented in these trials.

Jacobsen: When it comes to increasing participation from diverse populations in clinical trials, how does this align with the efforts of many organizations to improve diversity, equity, and access? Many organizations are focusing on these issues, which are practical and crucial to people’s lives, impacting not just life-and-death matters but also routine checkups and health maintenance throughout one’s lifetime.

Niles: Many of us, particularly men, must focus more on our health. Men often avoid visiting healthcare providers, skip annual checkups and miss important preventive measures and screenings. According to the CDC, men are 33% less likely than women to visit their doctors. The first step in addressing this is to educate everyone, especially men, about the importance of going to the doctor. Preventing disease and addressing health issues early benefits the individual and the healthcare system.

What became clear in the national poll we conducted is that across all communities—whether men, women, people of colour, or the LGBTQIA+ community—there is a general interest in clinical trials. People want to learn more about clinical trials to decide if participation might be right for them. However, they have not participated primarily because they haven’t been asked. These conversations simply aren’t happening with their healthcare providers.

They don’t have the information to make informed decisions. That’s why returning to ensuring men visit their healthcare providers is the first step. If they can see their healthcare providers, that conversation may happen. Generally speaking, we found that 1 in 5 individuals were conversing with their healthcare providers about clinical trials, another key initiative to focus on. It’s about empowering individuals with knowledge and encouraging healthcare providers to have these conversations with their patients.

Jacobsen: With the recent survey and your findings about participation in clinical trials, what are some of the things that stood out, apart from expectations?

Niles: Overall, what we found was broad interest across the population. We surveyed more than 4,000 individuals and oversampled for various communities. Six out of 10 respondents expressed interest in participating in clinical trials. Many of us have heard the myth that people don’t want to participate, but we found the opposite. They do want to participate. Close to 9 out of 10 individuals said they need more basic information about clinical trials—understanding potential costs, confidentiality issues, etc. If they have this information, they may be more inclined to participate.

The overarching finding was that the key reason for not participating was a need for more information and conversations with healthcare providers. We like to say these populations are not hard to reach—they are hardly reached. They want this information. Clinical trials may not be for everyone, but at least people are open-minded and want to learn more. They recognize not only the potential positive impact on themselves but also on others like them who are living with the same illness. This work is vital for advancing medical science.

Jacobsen: Which population came out as the most neglected? If you look at it proportionately, which populations tend to be clinically unseen?

Niles: I would say—and I’m looking at our data because we have a lot of statistics here—that people of color, generally speaking, had a positive view of clinical trials. When we looked at people of color, 83% had a positive view, and 58% expressed interest in participating—a little more than 1 in 2. We can certainly do a better job of educating people of color about clinical trials. They strongly trust their healthcare providers, as do most individuals across the dimensions we surveyed. Still, only 20%, or 1 in 5, are having these conversations.

A similar trend emerged in the LGBTQIA+ community. Eighty-six percent had a positive view of clinical trials, and 65% were interested in participating. The message here is that, through the PAN Foundation, we are trying to educate everyone about the importance of clinical trials, no matter what community they belong to. We are definitely focused on increasing diversity in clinical trials.

How do we reach these communities with more information? It’s through initiatives like the one we just launched. Still, it’s also through community work because health happens at the community level. Partnerships with other organizations, particularly those focused on specific communities—such as the LGBTQIA+ or African American community—are key to spreading the message and reaching these populations.

Jacobsen: And what about the factor of mistrust? You’re reporting wide trust, but mistrust is still a factor. How are you considering this in light of the generally high trust toward healthcare providers? When you talk about mistrust, what is the factor at play here if trust is already high?

Niles: There is some mistrust, and rightly so, in various communities about clinical trials because of egregious practices that have occurred in the past. When we asked, for example, among people of coloror in general, only some were fully aware of these past practices and the misrepresentations that have taken place. In our view, this was a positive finding—that not everyone was aware of—because it presents a unique opportunity to change perceptions about clinical trials and encourage participation. Trust in healthcare providers is generally high in all the populations we surveyed. The challenge is that healthcare providers need to initiate these conversations, and individuals should be empowered to view clinical trials as a potential treatment option and feel confident in raising questions about whether a trial might be appropriate for them.

Jacobsen: How do you provide personal support for patients considering clinical trials? How do you ensure that individuals get the personalized support they need?

Niles: One of the things I want to explain is our initiative called “Opening Doors to Clinical Trials,” which may answer your question. We’ve just launched a robust digital platform designed to explain clinical trials because they can be difficult to understand. We directly address the potential mistrust that people may have, especially due to past practices. We’re not shying away from it. We want to be transparent and provide clear information on accessing clinical trials.

That’s the first part of the initiative. The second part is the development of what we call our “Trial Finder Tool,” which is more user-friendly than clinicaltrials.gov. It helps individuals find clinical trials that may be beneficial to them.

But to answer your question more specifically, the third piece of our initiative involves our “Companion Access Navigators.” These are live people that individuals can speak to about clinical trials. They can help answer questions like: How do I find clinical trials? How do I have this conversation with my healthcare provider? What costs might I face if I participate in a clinical trial, and how do I navigate those costs?

In the first few weeks of launching this initiative, we’ve received calls about clinical trials and the “social drivers of health.” These are often the issues that prevent people from accessing healthcare in general. For example, suppose someone struggles to afford food, pay rent, or cover utility bills. In that case, these everyday life challenges may prevent them from focusing on important steps to improve their health, like going to the doctor or considering participation in a clinical trial. Through our navigators, we’re helping address these concerns by connecting people with resources in their local communities to alleviate those burdens and reduce the stress those factors can cause.

Jacobsen: How do you get men involved? I suspect this is generational, too. It’s probably a trite observation, but—

Niles: No, you are correct in general. Younger individuals may be more open to having a conversation about clinical trials. ‘How do we get men involved?’

There’s no easy answer for that. One way is to do interviews like this and get information through the media and publications, certainly through our website. We get a lot of visitors to our site, so we’d like to raise awareness that way. Another strategy is building relationships with organizations solely focused on men’s health; a few out there are doing a good job of that. We also speak at conferences and do media interviews.

There’s no single way to approach this. Men are one area of focus for us, as are people of color, the LGBTQIA+ community, and others. As a concept, diversity is broad and can be defined in many ways. So, we’re working all the angles—reaching men through their partners and spouses, for example.

I was the CEO of a national women’s health organization. I often say that women are typically the “health CEOs” of their families, which is generally true. So, working with women to encourage their partners and spouses to focus on their health is another opportunity. 

Jacobsen:We find, and this may also be generational, that married men tend to live longer and healthier lives than those who are not married. That factor may be influencing that cohort as well.

Niles: I have a statistic from the Global Burden of Disease Study. It states that men’s life expectancy is 6.5 years shorter than women’s. So, regardless of the numbers, we have a long way to go in improving our focus on prevention in this country and engaging people—no matter what community they’re part of—in their health.

Jacobsen: What are companion access navigators?

Niles: It’s a play on our organization’s name, PAN. PAN is a national healthcare organization whose sole focus is accelerating treatment access. We do that in three ways.

First, we provide financial assistance to people eligible for our programs to help cover the treatment costs they need. Second, we advocate for policy solutions to improve access to care. Third, we focus on education, including clinical trials as part of our education efforts, and advocacy, as legislation focuses on diversity in clinical trials.

Our companion access navigators respond live to questions people might have about clinical trials. They help people understand where to start and walk them through the process. They can guide individuals through our website, which has comprehensive information on clinical trials. They can also explain the types of trials and what questions might be asked when a sponsor considers them for a trial. They can also explain what individuals may need to think about before participating.

If the trial is being sponsored at an academic institution 200 miles away from someone, how will they get to that trial, and what are the costs involved? Walking them through all this information is key, but if cost is going to be an issue, helping that person find some support in their community will encourage their participation in the trial and not discourage them. 

Jacobsen: When looking at barriers, what would they be if you had to list your top five most significant ones?

Niles: Yes, cost is always an issue. We see it daily at the PAN Foundation—the cost of treatment and the costs associated with getting treatment. That is always a barrier. Geography can also be a barrier. Many people in this country live in rural areas far from clinical trials.

So, how do we engage those individuals? Another barrier is the need for more communication between patients and healthcare providers. If those conversations aren’t happening, we’re not doing the best job we can to encourage participation in clinical trials. We heard concerns about confidentiality through the survey, and our companion access navigators can also help address those. But overall, cost is always at the top. Some level of mistrust also exists, but that’s what we’re trying to overcome. 

Jacobsen: In some cases, it’s not full mistrust but healthy skepticism, which is beneficial. I wonder if a future survey could explore this healthy reservedness—where skepticism is appropriate in any health context so patients can take the proper precautions while not letting excessive mistrust prevent them from participating in clinical trials.

Nile Yes, I agree. A little skepticism is healthy, especially when it helps ensure patients ask the right questions. But when it crosses into too much mistrust, it becomes an issue because people miss out on trials and potential treatments.

Niles: You’re absolutely right. Individuals need to know they are their own best advocates. They should have some skepticism when a healthcare provider prescribes a certain medication. They should ask questions about the cost, the side effects, and whether a more effective or less costly option is available. However, many patients, and this is definitely generational, may be fearful or hesitant to question their healthcare provider, thinking the provider knows best, and their questions might be perceived negatively.

It’s so important to ask those questions. Ultimately, it’s a partnership between the patient and the healthcare provider. Still, the patient should always decide what’s best for them, whether regarding a medication or participating in a clinical trial.

Jacobsen: Excellent. Amy, thank you so much for your time today. I really appreciate it.

Niles: Thank you.

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