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Diversity in Clinical Trials: Let’s Get Practical  

Clinical trials play a pivotal role in advancing medical research and innovation, serving as the testing ground for new treatments and therapies. But to achieve diversity in clinical trials, trials must include a diverse range of participants representing all possible demographics that could potentially benefit from the treatment.  

But disparities in healthcare outcomes among varied demographic groups are alarming. For instance, Black women with breast cancer face a 41% higher mortality rate than Caucasian women and a 39% higher recurrence rate. Moreover, Black women are three times more likely to develop triple-negative breast cancer. These disparities underscore the urgent need for diversity in clinical trials, as current participation rates among Black Americans stand at a mere 3%.  

CORE East, Halloran’s three-day retreat for clinical research and life science leaders, highlighted this disparity during the panel “Getting Practical about Diversity in Clinical Trials.” The discussion aimed to explore the importance of diversity, and barriers to participation, and highlighted the positive role of community engagement in clinical trials. Panelists shared real world success stories, best practices, and actionable recommendations to ensure clinical trials become more inclusive and representative.  

In this article, we explore the importance of diversity in clinical trials, the challenges in meeting diversity requirements, and the critical role of community engagement in transforming the landscape of healthcare research. 

Clinical Trial Challenges, Perceptions, and Recommendations  

The narrative around clinical trials has been historically painted by betrayal and skepticism. What’s behind this?  

One of the biggest concerns in unsupported communities is that doctors don’t often invite them to participate in clinical trials, but if they are invited, they fear they’re going to just get a placebo while still maintaining the responsibilities of a trial patient. This skepticism is largely rooted in miseducation (or stories shared throughout their communities) about clinical trials. While clinical trials are a standard of care option, skeptical communities wouldn’t see it that way because of a lack of opportunity and gaps in health literacy.  

Engaging with diverse communities must begin early in the clinical trial process, involving community leaders and addressing the specific needs and concerns of various unsupported populations. Clinical trials should be presented as a valid treatment option and not as a last resort. By changing the way clinical trials are offered from the onset, we can ensure better participation and more representative results. 

Different groups may require tailored materials that resonate with their unique perspectives and experiences. Medical schools have recognized the importance of clinical research and ethics training, which can help bridge the gap in healthcare disparities. Efforts are also underway to create a database of diverse Principal Investigators, creating a network of Black and Hispanic leaders. 

There are organizations like TOUCH, the Black Breast Cancer Alliance, working to address these challenges by advocating for inclusivity in clinical trials, acknowledging clinical trials are no longer a dirty word, and recognizing the inclusivity problem is the first step.  

Building Community Trust 

In addition, the industry must move from talk to action. But what does that look like? During this session, panelists believe that by educating patients and demonstrating the connections between clinical research and common medications, the building blocks of trust can be built, and myths may be dispelled. 

Trust is built through education and by building relationships, and through those relationships, patients can become more empowered to demand the care they deserve. Breaking down scientific jargon and explaining standard healthcare practices to patients should be the standard. Without trust, the goal of enrolling diverse participants in studies becomes unattainable.  

It’s essential to change the way we communicate about clinical trials, using language that everyone can understand. Clinical trials should be presented as one of the choices available to patients from the moment they are diagnosed, which can lead to better patient outcomes and provide hope for a healthier future. 

FDA’s Diversity Action Plan Requirement  

In April 2022, the U.S. Food and Drug Administration (FDA) issued a draft guidance recommending sponsors develop Diversity Action Plans to improve enrollment of diverse populations in drug and device clinical trials, but questions remain about what should be included in such plans, when and how the plans should be submitted, and best practices for patient engagement and advocacy.  

As per the guidance, the sponsor is asked to include an overview of the disease, a description of the development program inclusive but not limited to how the trial or study may address inclusion of unsupported minority and ethnic populations, goals for enrollment, and strategic operational plan for enrollment including site feasibility, community engagement, and study design optimization. It is critical sponsors interact early with the FDA regarding Diversity Action Plans to allow enough time to modify throughout their clinical development. 

In summary, diversity in clinical trials is not only a moral imperative but a necessity for advancing healthcare. By addressing the challenges, building trust, providing varied treatment options, engaging communities early, and embracing diversity at every level of healthcare research, we can pave the way for a more equitable and effective healthcare system. It’s time to work together to ensure clinical trials truly represent the rich tapestry of our society, leading to better health outcomes for all. 

Connect with us today to talk through your Diversity Action Plan and patient engagement approach. We’re ready when you are.