By Deborah Borfitz 

December 4, 2024 | The PAN Foundation, a nonprofit that has been providing financial assistance to patients with life-threatening, chronic, and rare diseases since 2004, has just launched an Opening Doors to Clinical Trials initiative aiming to improve equitable access to studies. Assistance is now freely available to people everywhere in the form of basic education about trials, a user-friendly trial finder tool, and a live person who can answer questions and direct them to needed resources, according to Chief Mission Officer Amy Niles. 

Advancing the notion of clinical trials as an option on individuals’ healthcare journey is the overarching goal here, especially for historically underrepresented groups from marginalized communities. The move comes on the heels of ramped-up interest among federal agencies and congress to ensure diversity in clinical trials as well as a recent survey finding a huge gap between people wanting, and getting, a conversation with their healthcare providers about trial participation opportunities, Niles says. 

Nearly 4,500 people living with chronic conditions were surveyed to enable subgroup analysis of specific populations, including those in the Black, Hispanic, and LGBTQIA+ communities, she says. Overall, six out of 10 respondents expressed an interest in participating in a clinical trial and positive views of trials was notably high among both people of color (83%) and those identifying as LGBTQIA+ (86%)—even if only 22% and 20% of them, respectively, reported having had a conversation about trial participation with their doctor. 

“According to the participants in our survey, healthcare providers are trusted sources of information ... but, unfortunately, we found a gap in communication around clinical trials,” says Niles. “This equates to a real missed opportunity.” If surveyed individuals considered a trial at all, their sources were most often whatever they could find via self-research online and through social media and digital news outlets.  

The chronic disconnect between enrolling studies and would-be participants is well known, and often explored from the vantage point of a single disease such as multiple sclerosis or prostate cancer, Niles continues. That the PAN Foundation has taken a disease-agnostic approach to the problem means it is well-positioned to educate and advocate for equitable access to clinical trials, and thus a healthier future for all. 

Mission Expansion

The PAN Foundation is best known as a charitable foundation providing financial assistance to people who are under-insured to help them afford their treatment, says Niles. The decision to expand that mission to include even more educational resources, including those around clinical trials, goes back several years when it was updating its strategic plan for improving access to care. 

“We knew that we were a trusted source of education for patients for about 20 years and we could play a really unique role in providing education around clinical trials,” she says, in large part because its work cut across many disease areas. At the same time, multi-stakeholder groups, including the U.S. Food and Drug Administration and the National Institutes of Health, were beginning to outline actionable steps for improving diversity in trials. 

Clinical trials became one of the key issues identified as important to patients, as laid out in a board-approved position statement guiding the PAN Foundation’s priorities for advocacy efforts. This led to the first national poll of people living with chronic conditions, in 2023, finding that three out of four people wanted more information about clinical trials, says Niles.  

“It wasn’t enough to think of patients as one monolithic group,” she continues. “We wanted to dig deeper... and gain the perceptions of populations who have historically been underrepresented in clinical trials.” 

This resulted in a decision to undertake the more recent population-level survey, conducted in July 2024 by The Harris Poll on behalf of the PAN Foundation, oversampling for people of color and LGBTQIA+ adults to ensure their voices were adequately represented. The Opening Doors to Clinical Trials initiative was launched a few months later to help close the identified gaps—the most glaring of which was that “conversations with healthcare providers are not happening... across all the groups we surveyed,” Niles says.  

The lack of dialogue is probably both because healthcare providers are not raising the subject and patients “either don’t know enough to raise it as a conversation point or maybe just don’t know what to ask,” she adds. Familiarity with clinical trials was highest among Blacks and Asian Americans and lowest among Hispanic Americans and, for those who had participated in trials, the overarching sentiment for doing so was to help advance science and other people who may look like them. 

Although there have been egregious clinical research practices in the past that have left vestiges of mistrust, it did not rise to a level some people may still assume exists, Niles says, “at least for the people we surveyed.”  Rather, the main barrier is “limited provider outreach.” 

In the case of underrepresented groups, the problem is exacerbated by “unconscious biases” about their ability to understand a medical condition, she adds. Overly strict inclusion and exclusion criteria in study protocols can disproportionately affect people from marginalized groups who might have higher rates of chronic conditions, as can the logistics of getting to a study site for people living in rural areas or who have work and childcare constraints. 

Social determinant of health (SDOH) issues like these are “not easy to tackle,” Niles says, and one of the reasons the Opening Doors to Clinical Trials initiative includes the availability of so-called ComPANion Access Navigators to provide live, real-time assistance in breaking down those barriers. 

Three-Pronged Approach

Basic information about clinical trials, why diversity matters, and shared stories about trial participation are now available on the PAN Foundation website. The content had a significant positive effect on focus groups reviewing the material prior to launch in terms of their views of trials and willingness to consider participation, says Niles. The power of this easy-to-navigate digital platform is in improving health literacy. 

A trial-finding tool is also available on the website, which leverages information from ClinicalTrials.gov but in a much more consumer-friendly way, she continues. Nearly 7,000 trials can be searched based on criteria such as disease area and travel distance. 

Perhaps the most important component of the initiative is the personalized assistance provided by the ComPANion Access Navigators working out of the PAN Foundation, she says. Two full-time individuals currently fill this role, answering general questions about clinical trials, helping callers use the trial finder tool, and addressing some of the SDOH-related factors getting in the way of study participation. “We may not be able to solve all the problems... [but] we will find resources in a person’s community who may be able to provide [the needed] assistance.” 

A backup team of extensively trained ComPANions are ready to jump in as the program grows in response to a national awareness campaign now underway, says Niles. “We are fully committed to expanding these resources... and they are deeply committed to improving access to clinical trials.”  

Since much work remains to be done, outside financial support will be welcomed from different stakeholder groups and companies as the Opening Doors to Clinical Trials initiative ramps up, she says. As it is, people who are eligible for financial assistance from the PAN Foundation to cover the out-of-pocket cost of their prescription medications may also be eligible for a transportation grant so they’re able to get to their healthcare provider or pharmacy to pick up those drugs.  

Early feedback on the initiative has been uniformly positive. Ramona Burress, PharmD, development officer for the nonprofit Onyx Medical Wellness and formerly head of patient engagement and insights at Takeda Pharmaceuticals, says the PAN Foundation is a “great bridge to activate patients” who may be unaware of clinical trial opportunities or lack basic knowledge. 

This is in part because PAN uses healthcare providers, including pharmacists, who are “the most accessible and trusted clinicians for many rural and urban communities,” she says. Additionally, patients who turn to PAN desperate for financial assistance often receive it, “thus building a trusting partnership between the two groups... [so] education on clinical trials is better received.” 

Access to clinical trials is “no longer an option of last resort,” says Burress. Trials are therefore important connection points to innovative drugs for patient communities who are often socioeconomically challenged and dependent on government-funded health insurance.