Clinical trial for COVID 19

Keith Norris, MD, was in his 20s when both of his parents died from heart-related disease.

It was a seminal moment in a career focused in part on equity in clinical trials – studies involving patients that evaluate the effectiveness and safety of medicines, devices or lifestyles to prevent or treat disease.

“I wondered whether my parents could have benefitted had more clinical trials during that time involved patients who were Black,” says Dr. Norris.

When researchers are trying to determine if a new medication is effective, data points like blood pressure can act as strong informational signposts, Dr. Norris says. But when it comes to how race and ethnicity impact results, the data may not be as obvious.

“We should be more cautious against drawing conclusions from studies looking at small groups,” says Dr. Norris, a distinguished professor of medicine at the David Geffen School of Medicine at UCLA. “Just because a medication shows promise for one racial or ethnic group doesn’t guarantee the same outcome for everyone.”

Dr. Norris and Arleen Brown, MD, also a DGSOM professor of medicine, are leading work to address representation in medical research and to ensure equitable healthcare. They co-direct the UCLA Clinical and Translational Science Institute (CTSI) Community Engagement Research Program, which supports researchers in designing more inclusive clinical trials.

CTSI offers support to researchers through large investments that are critical to success, such as figuring out how to get internet access to a rural community. Experts can also help with regulatory and other process-related challenges.

There are also service-level activities, such the community engagement research program led by Dr. Brown. Members work with investigators to help them build trust and minimize potential roadblocks for participation in clinical trials.

“Community education and proactive partnerships are critical to making medical research more diverse and developing therapies that are effective for everyone,” Dr. Brown says.

Currently, Dr. Brown and Dr. Norris are part of the leadership team for the Science of Diversity in Clinical Trials project as partners of the American Heart Association.

Launched in 2022 with colleagues at University of Hawaii, Manoa, and Washington State University, the project specifically studies Native Hawaiians, Native Americans and other minority groups. Researchers use messaging strategies such as texts and videos to encourage people to participate in studies about heart health.

Barriers to clinical trial diversity

As a large academic health system with a history of translating research discoveries into medical breakthroughs, UCLA Health engages in a wide variety of clinical trials – 1,500 at any given time.

Cultural, social and socioeconomic factors continue to influence the lack of diversity in clinical trials past and present, says Dr. Norris.

"To get participants from underrepresented populations,” Norris says, “you have to consider what the reasons are as to why they may not be participating.”

Some of these reasons fall under the social determinants of health, such as lack of transportation and childcare. Other barriers are distrust of researchers, lack of knowledge about research processes and fear of potential negative effects or risk.

Dr. Norris suggests overcoming these barriers using tactics such as establishing diverse research teams and dedicating increased resources to directly address patient barriers. The current project with the AHA explores hula dancing activities and nutrition for heart and metabolism-related issues such as high blood pressure or diabetes, research for sleep apnea, and aims to increase representation by including factors such as age, gender and specific health conditions.

Additional UCLA researchers are exploring ways to diversify studies:

  • Starting July 2024, an interdisciplinary team will study how tests used to determine eligibility for new drugs like Lecanemab to treat Alzheimer’s Disease may vary in different racial and ethnic groups. They then plan to develop educational tools for patients and providers that highlight the differences, with the end goal of adjusting care for each group. Neurologist Timothy Chang, MD, PhD, Integrative Medicine and Physiology researcher Kacie Deters, PhD and bioethicist Nanibaa’ Garrison, received a four-year Alzheimer’s disease Research Award grant from the California Department Public Health.
  • Jennifer Adrissi, MD, assistant professor-in-residence of neurology, is developing a questionnaire that will include questions about factors that are known to influence the likelihood that a Black individual will sign up for a clinical trial. The assessment will ultimately help Parkinson’s disease researchers evaluate and improve their recruitment of Black participants in clinical trials.

“It’s important for teams going into a community to provide the background and lay the foundation with patient advocates, leaders and organizations about what a clinical trial is, why they are important, when is there benefit (or not) to a patient, why we need to do a given trial and why UCLA is a trustworthy partner in doing clinical trials,” says Arash Naeim, MD, associate dean for clinical research for the David Geffen School of Medicine at UCLA. Their support can help addresses obstacles tied to recruiting and retaining volunteers for clinical trials.

The long-term goal, Dr. Norris says, is for the right treatment to be delivered to the right person at the right time, for all populations.

Research is a community effort

While health care professionals and institutions have made strides to diversify clinical research, progress has been slow largely because of systemic issues and lack of investments, Dr. Norris says. Nonetheless, he and colleagues are seeing positive change resulting from increased awareness and policy shifts around diversity in research.

“Just the fact that it’s a conversation is progress,” he says.

Race and ethnicity reporting and equitable enrollment in U.S. clinical trials, while historically poor, has improved in recent years for all groups.

A key point of moving toward inclusivity revolves around involving community leaders and organizations in research projects, recommends the National Academies of Sciences, Engineering, and Medicine which recently had a team of researchers including Dr. Brown take a close look at this issue.

For example, during recruitment, a person may be faced with an on-the-spot decision about their participation. Ideally, they will have the necessary information based on what they heard from trusted community leaders or learned themselves, to give them peace of mind regarding past negative health care experiences or historical concerns.

There is a moral and scientific urgency, he says, to increase diversity in clinical trials, build trust with communities and promote fairness. But it is our job to prove to our communities we are trustworthy, he says.

“We must continue to address each trial and community barrier to optimize a representative group of participants,” Norris says. “At the end of the day, all communities benefit from advancements in quality medical research.”

This article was originally posted in the UCLA Health Newsroom

Image source: UCLA Health