Diversity Action Plans Will Soon Be Mandatory for Clinical Trials

It’s time to think about creating diversity plans.

In December 2022, Congress passed the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, which made diversity action plans mandatory. By December 2023, the FDA will issue guidance on the format and content of these plans.

“We don’t have to wait until then to understand what’s involved,” said Steve Smith, President, Patient Advocacy, WCG. “Many sponsors already have such plans in place, and those that don’t need to start,” he added.

Smith was one of three speakers in a recent WCG webinar titled, “Understanding the Evolving Multicultural Landscape and its Effect on Clinical Trial Participants.”

What’s in a Diversity Plan?

Citing legal experts¹, Smith outlined what sponsors should include:

1. Enrollment goals, disaggregated by age group, sex, and racial and ethnic characteristics;
2. The rationale behind these goals, including information about the condition and its prevalence and/or incidence among various demographic groups; and
3. How the sponsor will accomplish these goals, such as outreach and enrollment strategies, inclusion and exclusion practices, and diversity training for study personnel.

“The message from the FDA,” he says, is this: “Optimize data collection so all people can contribute.” Here’s what that looks like: ”

• Limit exclusion criteria: The FDA has acknowledged its past guidance may have led sponsors to go overboard on their inclusion/exclusion criteria. The agency is now trying to be more open and flexible, Smith said.
• Embrace digital health to identify participants based on demographics.
• Reduce burden on participants to improve access. A large part of that is incorporating elements of a decentralized clinical trial, such as remote technology and measurement.

The FDA is not only open to communicating with sponsors about diversity, they are eager, he reported. This represents a dramatic change, and sponsors should avail themselves of the opportunity.

Understanding Intersectionality

“As sponsors think about diversifying populations within clinical trials, they need a deep understanding of what diversification means,” said Scott J. Hunter, PhD, Senior Scientific Expert, Neurodevelopmental Disorders and Rare Pediatric Diseases, WCG.

The key to that understanding is a grasp of intersectionality. Intersectionality considers many aspects of a person’s identity, such as race, gender, sexuality, socioeconomic status, and disability, which influence their experiences and interactions with the world.

Understanding intersectionality helps us recognize how existing social structures of power and exclusion affect access to healthcare and to clinical trials, Hunter explains.

Historically, healthcare research has focused on privileged demographics, such as non-disabled white males. This has resulted in a limited understanding of the effectiveness and suitability of treatments for underrepresented populations. “Clinicians and researchers need to understand that the experiences of the prototypical white male do not encompass everything we need to know about health, disease and the experience of illness.”

So how do we engage diverse identities in clinical trials?

• Community roundtables involve meeting with key players in the community, including patients, caregivers, and community support members. “This allows us to discuss ways that we appreciate the barriers and the supports to recruitment, that we can then engage with and adjust.” It also cultivates cultural humility and helps everyone involved in clinical trials appreciate how their own biases may hinder recruitment success.
• Accessibility covers many elements, from language to how to address and support study demands. Such support includes mechanisms for better transportation, payment, engagement and communication.
• Data management includes thinking about the breadth of demographics rather than merely static identities like race or gender.
• Addressing stigma directly requires clinical trial stakeholders to examine their own biases and appreciate the experiences of others.

He also emphasized that decentralized trials will go a long way toward ensuring a study includes participants across racial, ethnic, socioeconomic, regional and other identities.

Pushing Past the Bias

The lack of diversity in clinical trials reflects a larger failure in the healthcare system as a whole. Loretta Veney — author, patient advocate and caregiver – A Black woman who shared her family’s experiences that vividly illustrate health system disparities.

In 1988, she began her journey, dealing with abdominal and pelvic pain, which her first gynecologist dismissed. After multiple hospitalizations, she was finally diagnosed with severe endometriosis. “That misdiagnosis by my first doctor resulted in 40 hospitalizations and 21 surgeries over a 13-year period. What a saga. That was absolutely a life-changing situation because I had only been married for two years, and then wasn’t able to have kids.”

Then 2006 brought what she calls the “trifecta.” Her aunt, Diane, was diagnosed with colon cancer; her sister, Renee, was diagnosed with multiple sclerosis; and her mother was diagnosed with dementia.

Diane had a deep mistrust of doctors because of Veney’s ordeal and ultimately died of colon cancer. “She would’ve never even considered a clinical trial as an option. I can even hear her voice: ‘I’m not going to be anybody’s guinea pig.’”

Renee, in contrast, was open to a clinical trial. Veney learned everything she could about MS and tried to connect her sister with a trial. “The only information we got was that clinical trials are usually for much younger people with MS.” Finally, someone promised to investigate whether there was anything for people with progressive MS. No one followed up. Renee died at 61.

Veney’s mother was diagnosed with dementia at 77. The neurologist never made eye contact with her mother. He simply said, “You’re in the beginning stages of dementia.” He didn’t give her time to gather herself; he just wrote a prescription. Her mother said she didn’t want to take the medication. The doctor’s response: “That’s what’s wrong with you people. You don’t want help; you just want to complain.”

Fortunately, her mother eventually  ended up with two wonderful doctors, and the “you people” comment led to coverage in Psychology Today.

Veney understands first hand why so many people are hesitant to take part in clinical trials. “Sometimes the things that we endure through our lives really set the stage for mistrust for years to come.” She’s working to overcome this mistrust. She encourages others to do the same by engaging with their communities and hosting forums to discuss health issues and clinical trials.

“I speak to African American groups about the benefits of clinical research,” she says. “I think there’s so much power in knowledge.”

References:

1. Hyman, Phelps, McNamara, FDA Law Blog