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Representation Matters: Best Practices to Increase Diversity in Clinical Trials
Thursday, March 24, 2022

Representation Matters: Best Practices to Increase Diversity in Clinical Trials

By: Leslie Doyle

For many conditions such as cancer, clinical trials increase patients’ survival rates. Yet a stark gap remains between the number of minority patients affected by such diseases and those participating in clinical trials. Having a diverse population in clinical trials is imperative for public health. This ensures that medications are safe and effective across a wide population — and offers all people equal access to emerging, often life-saving, therapies.

For example, Black adults are two to three times more likely than their white counterparts to contract multiple myeloma, yet a study presented by the American Society of Clinical Oncology (ASCO) found the median percentage of Black patients enrolled in clinical trials was just 4.5%. More equitable representation of Black adults in this research could improve the likelihood that the resulting therapies would benefit these patients. There are many hurdles that can stand in the way of achieving equitable trial representation across ages, races and ethnicities. Through continuing medical education (CME) programs, we can work toward achieving this goal.

“Continuing education is relevant for many different stakeholders [involved in clinical research],” Susan T. Vadaparampil, Ph.D., MPH, associate center director for community outreach, engagement and equity at the Moffitt Cancer Center, says. “For the cancer center, it’s about how we’re making sure our trials meet the needs of the community we serve and how best to engage our community. Continuing education is also about reaching our community physician colleagues who are often the first people diagnosing a patient. They can provide more information about the particular diseases as well as the value add of therapeutic clinical trials.”

Many health organizations are developing educational sessions both to increase awareness among peers about the benefits of clinical trials and to share best practices for increasing minority representation. “I foresee educational programs highlighting how generalizable and novel innovative therapies have led to FDA approvals,” Dr. Kedar Kirtane, a medical oncologist and health disparities researcher at Moffitt Cancer Center, says. “People of different ethnicities, for example, metabolize drugs differently, and it’s important that no one be left out both in terms of testing emerging medications and having access to novel therapies.”

There are several approaches that are advantageous for CME programs about trial diversity, including:

Engaging primary care providers. Often, people think of clinical trials being introduced once a patient sees a specialist like a hematologist or oncologist. However, it’s equally important to include primary care providers in these conversations. “Primary care providers are often the first people to see the manifestation of cancer,” Dr. Kirtane says. “If clinical trials are part of that initial discussion, this helps patients feel supported and understand that research studies are a part of oncology care in 2022. You can’t talk about oncology without talking about clinical trials.”

To that end, Moffitt is building connections with providers in community settings. “We tend to focus on disease states, but if we think deeply about who potential partners could be, we can get people the best care at the best time,” Dr. Vadaparampil says. “For breast cancer, this could be communication with OB-GYN or primary care providers who order routine mammograms, for example. Our goal is to make things easier for our provider colleagues in community settings so if they have a question or want to refer a patient, we make it as smooth as possible to reach us and to find trials.”

Breaking down provider biases. Studies have found providers sometimes view Black and Hispanic patients as being hesitant to participate in trials or lacking the resources to support them through the trial. This can lead to these patients not being offered trial opportunities.

“A provider may subconsciously assume someone is unwilling or unable to participate in a trial independent of medical issues or have a misconception that they won’t be able to complete a trial,” Dr. Kirtane says. “This can unwittingly restrict people from participating in a medical intervention. One way to break through these barriers is to offer CME programs focused on provider bias. These eye-opening programs are intended to increase self-awareness and share approaches for conducting more equitable research.”

Building support networks to overcome obstacles to trial access. Financial and travel constraints are a major hurdle for many patients to participate in trials. Including health advocacy and other support organizations in CME programs can help providers understand what resources are available to their patients to address these obstacles. The Leukemia & Lymphoma Society is one organization that shares information about its financial support resources through numerous webinars held throughout the year.

Connecting community oncology providers with specialists. “Treatment paradigms are changing every day, so having interactions between specialists and generalists will help patients who can benefit from these emerging therapeutic approaches,” Dr. Kirtane says. “It’s not reasonable for general oncologists to be expected to know about every single trial out there that could benefit their patients. One way to help community providers navigate the seemingly overwhelming number of trials out there is to connect them with specialized centers like Moffitt Cancer Center who are focused on particular areas of cancer.”

Including patient voice. Sharing patients’ lived experiences during CME programs has proven to help increase provider engagement and overcome gaps between perceptions among providers and patients. “In our head and neck oncology CME programs, we found we had just as much to learn from patient experience as anything else,” Dr. Kirtane says. “It’s illuminating for providers when patients directly characterize their experience.”

Fostering open discussions instead of just giving presentations. CME programs are moving toward more panel discussions with pre- and post-survey questions to increase the dialogue among participants and to build bridges between providers. There is a trend toward increasing the amount of Q&A time in sessions to allow participants ample time to ask unique and specific questions. “Physician-to-physician communication has the added value of building mutual trust and engagement between two very important groups,” Dr. Vadaparampil says.

Sharing data. Different groups of people can react differently to the same therapy. For example, biomarkers of head and neck cancers can vary for people of different ethnicities. Having equitable representation in clinical trials is key to understanding these differences for the development of effective treatments.

To that end, CME program developers can share data about recently approved medications to illustrate the importance of diversity in clinical research. “I’d like for healthcare providers to know how recently FDA-approved drugs for head and neck cancer came out of national and international trials,” Dr. Kirtane says. “Explaining the science that led to these advancements can help demonstrate the power of research.”

Measuring outcomes. To gain actionable data to improve care, educators need quantitative and qualitative information to determine whether their CME programs are ultimately increasing health equity when it comes to research. Metrics may vary by program but could include measuring:

  • Increases in referrals and inquiries for trial participation
  • Improvements in the representation of trial participants at a particular center in relation to the epidemiology of the disease
  • Provider competency questionnaires to gauge impacts to clinical practice

Gaining more equitable representation across clinical research is a challenge that will not be solved overnight, but it is a crucial one that we must work together to solve. CME programs can serve as a means for both education and connections that are necessary for understanding and overcoming the obstacles to reaching this goal. By engaging stakeholders across the healthcare community, we can discover innovative approaches to achieving greater health equity.


Leslie Doyle is the content manager at PlatformQ Health.

Keywords:   Leadership

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