By Deborah Borfitz 

July 14, 2021 | A panel of experts offered their insights on how to “fill the gaps” when it comes to diversity and inclusion in clinical trials at the recent DIA 2021 Global Annual Meeting. The lively and informative session was moderated by Clare Grace, chief patient officer at Parexel, filling the first such role in the CRO industry.

Although the U.S. Food and Drug Administration (FDA) issued guidance on clinical trial diversity over 10 years ago, she says, little actual change has been achieved. And all the talk about outreach to local churches and barbershops can be “highly insulting.” 

The limited time patients have with their primary care physician has made it difficult to “build common ground” and trust with the research community, says Yasmeen Watson, a patient who survived stage 3 colorectal cancer thanks to clinical trials. 

As the primary caregiver for two of three daughters with an autoimmune disease in the U.K., Ila Gangotra says she was left to do all her own investigative work after their life-changing diagnosis and “it was quite a shock.” She had to search for answers to her questions about clinical trials, including outcomes of participants to date and the adverse reactions. 

It was a “missed opportunity for engagement” with cultural and racial healthcare organizations, says Gangotra. She has been active with the Asian MS support group for over a decade, and industry has “not once” approached the organization to engage.  

A Television First 

The most missed opportunity is engaging the entire family, according to Fabian Sandoval, M.D., chief executive officer and research director of Emerson Clinical Research Institute (ECRI). Inadequate time is given to bringing relatives into the discussion, especially for more critical diagnoses such as multiple sclerosis (MS), and the oversight has “gigantic ripple effects” downstream as a study progresses. Family members might not encourage the patient to continue with a trial as the visits, e-diary entries, and other study-related expectations mount. 

Research gives patients the time they want with physicians, but cannot get during routine appointments with their doctor, and is one reason patients sign up for studies in the first place, Sandoval points out.

Talking to patients in their native tongue is important, he adds, since interpreting information delivered in a second or third language can be difficult under the best of circumstances. Anyone who is sick may not want to try.

Sandoval’s communication tactics include the launch of his own weekly medical television show “Tu Salud Tu Familia” (Your Health Your Family). When Hispanic patients started coming to ECRI, they thought it was “too good to be true” that they were being compensated for their time and travel, he says, because they did not appreciate the value of their research participation. 

Initially, he attempted to cover the basics during a short TV segment that aired during the 6 p.m. news, but it was not enough time to properly educate viewers. So, Sandoval created the Diversity Health Foundation to help launch and sustain the first-of-its-kind weekly TV show. 

Tu Salud Tu Familia is now in its third year and has 60,000 people watching every Saturday morning, he says. Viewers can call in with questions and learn what to ask for when talking to their physician about research. 

YouTube videos of the show play on Facebook and are archived on the ECRI website, Sandoval says. They are also posted to Twitter, although the social media platform is infrequently used in the Hispanic community, he notes. 

Eighty shows have posted to date and Sandoval is encouraging doctors to use the free resource.

When Yasmeen Watson received her cancer diagnosis, she was handed an 11-page brochure on her treatment options and did not understand much of it. What she was able to learn on her own came from Google searches and, especially, WebMD. 

Seeking to stay positive, she joined a support group to better understand her disease and, once she beat it, began working with several organizations to help others advocate for themselves and “not feel intimidated” when speaking to physicians, says Watson. 

Going It Alone 

Gangotra was included in her daughters’ decision-making process “right from the beginning,” she says. “I did all the research, and I am totally computer-illiterate.”

In lieu of searching online, she reached out directly to anyone who might have something to teach her about MS. She ended up filling a binder several inches thick on each of the multiple medication choices. 

One day while at her retail business, Gangotra approached a woman she frequently saw whose health had clearly deteriorated and learned she had MS. That chance encounter, she says, was her introduction to the National Multiple Sclerosis Society and its Asian MS support group. 

At one of the local support group meetings, the family learned about a hospital specializing in MS that was refreshingly family-focused and started attending “research days” being held there, Gangotra continues. It was a time she and her daughters could meet with scientists and become better informed about the study process—and, importantly, the information accommodated the national average reading age level (9-11 years old) and was available in multiple languages. 

With two other clinical trials the family had considered, they were instead handed a 30-page document they did not comprehend. The information would been more impactful had it been available in other formats and “co-created” with the communities being targeted, Gangotra says.

Time Matters 

“A conversation would have helped,” says Watson of her experience. Doctors, she believes, would rather that patients follow their orders than pepper them with questions. The underlying fear is that a dialogue might turn into a “circus” due to the ease of acquiring misinformation (e.g., blueberries kill cancer). 

It is unfortunate as well as unfair of physicians to get offended by what patients might learn online, says Sandoval. At some point they, too, will probably be a patient in need of time to digest some bad news. He cried a few years ago when he lost hearing in one of his ears, he recalls, and it did not help that his doctor glibly said, “At least your other ear is OK.” 

At ECRI, patients get the VIP treatment, Sandoval says, which includes study staff who show up on time and have breakfast ready for patients in the morning—even getting them a taxi to the office if that is what it takes. This is harder to do in regular, hospital-affiliated practices where the focus is on RVUs (methodology for calculating physician payment), causing a lot of work to get “rolled downhill to the study coordinator.”

The policy at ECRI is to spread the burden of running trials equally across study coordinators and not to overburden any of them, says Sandoval. Each study gets ranked based on its complexity and once the ceiling is hit—“20 is the magic number”—a new coordinator gets hired. 

Getting needed time from the specialty MS facility was “a weight lifted off my shoulders,” interjects Gangotra. It was also a welcome relief to no longer be “battling for the basics we wanted, like an MRI scan and neutralizing antibody test.” 

Addressing Barriers 

ECRI goes to great lengths to ensure the care team has the trust of patients. The staff is virtually all bilingual—90% speak at least a second language—and the welcome mat extends to patients who may not be legal residents or have insurance coverage, Sandoval says. As needed, ECRI will get patients a car or deliver medications to their home. 

As an aging caregiver, Gangotra has her own medical issues and would welcome anything that would lessen the burdens of research participation, she says. These include, most notably, the six-hour round trip to study visits at the MS specialty center. Keeping the number of required study visits to a bare minimum would be useful, she suggests. 

Gangotra’s other recommendations are to give transportation options (e.g., taxis, trains, buses, car) to study participants so they choose the one that is most convenient for them, and to reduce financial barriers by compensating patients upfront for study-related costs they incur. It was “not ideal” that one of her daughters had to make up a lost day of work every time she had a medical appointment, she adds. 

The idea of having studies offering conveniences such as home nursing, local practitioners, and remote monitoring sounds appealing, Gangotra says. When one MS treatment became available as a self-injectable, eliminating the need to travel to an infusion center every two months, “that transformed our lives.” 

Among the Asian population, remote monitoring might be a hard sell, cautions Gangotra, adding that her family is “an exception to the rule.” Culturally, Asians tend not to discuss medical issues, even among themselves, so they may not like having a healthcare professional come to their house virtually or otherwise.

The barriers for Watson are all before a trial begins, she says, and center on cultural mistrust of the medical system. “My community says no at the door.” 

Trial participation, she adds, is “not a conversation up for discussion with my family. I want to make an informed decision on my own.” What blacks need from the research community are help with transportation and verbal acknowledgment of past medical atrocities and the importance of diversity in the medicines development process.

To help reduce health disparities, the FDA now requires study sponsors to measure how well demographic subgroups (sex, age, race, and ethnicity) are included in clinical trials and if subgroup-specific safety and effectiveness data are available, says Grace. Principal investigators may need to be educated if they are unaware of historical events (e.g., USPHS Syphilis Study at Tuskegee) that fuel distrust, she adds. 

“Mass hysteria” surrounding COVID-19 has helped to make the medicines development process a dinner table conversation, Grace says. “It’s a big step forward, a silver lining.”

Watson’s one request of industry is to “build on the momentum” created by the pandemic now so many people are intrigued by research and know some of the terminology. Gangotra asks that industry embrace caregivers and their function, and to become more culturally sensitive via “long-term relationships with the right healthcare organizations.”

“It’s simple—be proactive and not reactive,” says Sandoval. That includes using study sites with a diverse team that can accommodate the language of people being targeted for enrollment.