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The pharmaceutical industry is placing new emphasis on making clinical trials more inclusive and diverse. Recent research provides insights into the challenges — and the opportunities.

There is little question that this past year has been unlike any other. 2020’s unprecedented political, social, and public health challenges have touched many aspects of daily life and led organizations in every industry to rethink the way they do business. Continued calls for racial justice, as well as COVID-19’s disproportionate impact on Black, Latino, Asian, and Indigenous communities around the world have highlighted longstanding inequities in healthcare and clinical trial access, and are driving the pharmaceutical industry to examine how it can address these issues. Companies are working to maximize safety and efficacy by focusing on ways to make trials more diverse, inclusive, and reflective of the populations their treatments are intended to serve.

Parexel, a global leader in biopharmaceutical services, recently surveyed, interviewed and led focus groups with more than 2,000 patients, doctors, and members of the public to better understand the critical barriers to research access for patients from diverse backgrounds, and to seek input on how to overcome them. The company released full research results in May, and Rosamund Round, Parexel’s Vice President, Patient Innovation Center says that they uncover a series of important themes.

Distrust runs deep

Parexel’s early findings indicate that many survey respondents identifying as Black, Latino, Asian or other non-White background cited a lack of trust in clinical trials. Much of this distrust likely stems from injustices like the 1930’s Tuskegee Experiment, where a group of Black men in the United States were subjected to dangerous medical testing without their knowledge. This damaged perceptions of clinical research for many members of the community. “I think people of color have to be very careful,” says one research participant who chose not to be identified by name. “I would personally be hesitant in joining a clinical trial.”

Participants surveyed through Physician Focus Groups say there’s no quick fix to addressing distrust, but that a sustained, long-term commitment to communication and engagement is key. “We have to be building that trust on a daily basis, and that means being out in those communities. It means listening,” says Wanda McClain, former Vice President of Community Health and Health Equity at Brigham Health. “We have to be doing this work all the time, we can’t just wait until there is a trial.”

Cultural sensitivity is critical

The survey found that cultural norms often impact how different populations interact with the medical establishment. For example, in some cultures, the head of the family may be the decision maker and in others, decision-making involves the entire family. And disclosing or discussing health issues can sometimes have a negative impact on the reputation of individuals and families. “In the South Asian community, if you’re diagnosed with a chronic or serious illness or you have a disability, it makes you ‘imperfect,’” says Advisory Council member Trishna Bharadia. “It can impact your marriage prospects… your job prospects…”

She believes a lack of cultural competency can discourage deeper conversations about participating in trials. “One of the real challenges is that there is a lack of awareness among doctors and clinicians that these issues even exist,” she says. “If a clinician puts forward an opportunity for a trial and (the patient) says ‘no,’ the clinician just takes it as ‘okay, it’s no.’” But understanding that “no” may actually be a response to not having the right family decision-makers in the room — rather than indicating a lack of interest — is an important distinction. 

Patient recruitment requires different approaches

Effective patient recruitment is critical to trial success, and Parexel’s research indicates that raising awareness in diverse communities involves rethinking the traditional way of doing things. “Focusing on trusted channels where information is delivered in patients’ preferred language can be an excellent approach,” says Round, who cites the El Mundo newspaper and radio shows broadcast by stations like BBC Radio’s Asian Network as two specific examples.

Yasmeem Watson, a member of Parexel’s Patient Advisory Council, adds that making direct connections in the community is another important way to generate interest in trials among specific populations. “You might have to go to a community center, a temple, (or) a church,” she says. “You’d be surprised by the level of conversations that happen (in these places).”

Support for native languages is key

Participants in Parexel’s research say one of the most effective ways to improve trial access and build trust is also one of the simplest: provide resources in multiple languages. “I still find myself asking, ‘Is that information available in Spanish?’” says Ivis Febus-Sampayo, another member of the Parexel Patient Advisory Council. “Or in other languages?” She believes that if the industry is serious about improving diversity, it must invest in supporting multiple languages. “(If) you want to reach out and bring diversity into trials, you need to show respect by putting your money where your mouth is,” she says. Parexel’s Round says that sponsors looking to enroll and retain non-English speakers should plan to invest in multiple translations of educational materials, use of videos and infographics to convey key information, and strive to partner with a more diverse physician pool.

DCTs matter, but they’re just part of the solution 

Decentralized Clinical Trials (DCTs), which take place at home or in the local community (as opposed to at a traditional trial site) can have a positive impact on improving access to clinical research by reducing practical and financial barriers. They can include home nurses, medication delivered to a patients’ door, sensors and oftentimes include a telemedicine component that can remove logistical and financial roadblocks to participation. But this model brings its own challenges. “The reality is, not everyone has a cell phone or Wi-Fi,” Round says. “So you might inadvertently exclude [certain groups] from the research process because they don’t have access.” But she says those issues can be addressed through practical steps such as partnering with patients and sites during planning to determine what percentage of patients will require provisioned devices.

And decentralized trials have the added benefit of providing clinicians new insights into patients’ lives while simultaneously improving compliance. “With telehealth, I have this window into people’s lives that I never had before,” says Kathleen Young, a child and adolescent psychiatrist. “It gives me a little more of a connection into what’s going on with them…and compliance has improved because the burden on patients has decreased.”

The big takeaway: Listen carefully, and think long term

Round says that while Parexel’s final report provides a deeper dive into how the industry can work toward more inclusive clinical trials, she sees a consistent theme running through the early findings. “You need to listen,” she says. “You need to work with patients and physicians to try to understand the issues and address them effectively without making assumptions.” Yasmeem Watson of the Parexel Patient Advisory Council agrees. “We have to go into the community and meet people where they are.”

And Round says that while there are a number of practical, short-term steps companies can take to improve the diversity of their trials, it’s important for the industry to acknowledge that real, lasting change requires a thoughtful, long-term commitment.

“It can’t be ‘Oh, 2021 is the year of diversity, let’s quickly do something,’” she says. “There can be quick wins that move the needle, but there also needs to be a meaningful collaboration and a sustained effort.”

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