Therapeutic potential of colchicine in cardiovascular medicine: a pharmacological review

This Reverend Wants To Change How You View Clinical Trials: "We're Not Going To Have Another Tuskegee"

Rev. Anthony Evans of the NBCI

Reaching Black people on major issues starts with going where they are. Historically, Black churches have been a resource and refuge in their communities, and they're helping to build trust with clinical trials.  

The National Black Church Initiative (NBCI), a coalition of 150,000 churches, has been the driving force behind the National Clinical Trial Strategic Plan to educate and inform Black Americans about clinical trials. Their efforts have helped to educate over 52,000 Black congregants, making it the most successful mission to close the clinical trial racial gap. 

That success is in major part due to trust and cultural competency. "We're proud to be working to educate and provide informed consent," Rev. Anthony Evans, the President of the NBCI explains to BlackDoctor.Org. There is also a level of protection since they vet the clinical trials before putting them before congregations. "I tell them that you have to verify through us that you're going to provide critical education, and you can't do that without going through the American Clinical Health Disparities Commission." 

NBCI's partnership with the American Clinical Health Disparities Commission (ACHDC) is aimed at a continued effort to combat health disparities including social determinants of health. ACHDC is made up of Black physicians, clinicians, and church leaders who are working to improve Black participation and clinical trials.

The commission's 42 physicians provide technical and scientific protocol as well as guidance, Evans says. This will inform the National Clinical Trial Strategic Plan. "I can't do anything until I pass the nature of whatever clinical trial they are doing through the commission, and the commission will authorize me to implement that program in our community saying that this is a reputable program."

The partnership's major goal is to close the health gap with Black Americans. While NBCI has struggled to be heard by Congress and elected officials, the hope is that their efforts allow them to have meaningful connections with the NIH and other bodies that could lead a large effort to slow down Black mortality. According to Evans, "We are working with a couple of continuous education firms to offer a course of how to deal with Black American patients. Non-Black researchers  know nothing about African American traditions, so we are creating this course to make sure that they know about us and respect our culture." 

"The reason why we are so formal is that these are lessons learned from Tuskegee," Evans added. "We're not going to have another Tuskegee on our watch." The Tuskegee Study of Untreated Syphilis stripped Black men infected with syphilis of informed consent and withheld medication. This led to lifelong health problems for participants and their families. 

That is why engaging organizations like the CDC and NIH are important.  Evans hopes that within the next few years, over 750,000 congregants will be introduced to clinical trials. Without the Black church, which is a soft place for many in the community to land, Black people may steer clear of trials and studies. "We can't do this alone, especially since we're late," Evans concludes."This should have been done 20 years ago, 30 years ago, but it is what it is, and that's where we are." 

Tuskegee University

History

Tuskegee was founded in 1881 by Dr. Booker T. Washington. Tuskegee attained University status in 1985 and has since begun offering its first doctoral programs in integrative biosciences and materials science and engineering. The College of Business and Information Sciences was established and professionally accredited, and the College of Engineering, Architecture and Physical Sciences was expanded to include the only Aerospace Engineering department at an HBCU.

Tuskegee University is a leading producer in the country of African-American engineering graduates in chemical, electrical and mechanical engineering. It is the only historically black college or university in the nation designated as the location for National Center for Bioethics in Research and Health Care. Tuskegee University is the home of a center for Plant Biotechnology Research which is training U.S. Scientists and students as well as scientists from Ghana, China, Nigeria, South Africa, Uganda, Egypt, and Tanzania to continue work of Dr. George Washington Carver in today's cutting-edge science and technology.

CCTS Partnership

Tuskegee University's area of investigative expertise is their National Center for Bioethics in Research and Health Care. This is the nation's first bioethics center devoted to engaging the sciences, humanities, law and religious faiths in the exploration of the core moral issues which underlie research and medical treatment of African Americans and other underserved people. Additionally, Tuskegee has expertise in computional analysis of focuses on correlating qualified ancestry across mult-omics platforms.

Tuskegee University participates in the CCTS Executive Council. In addition to the panels, they spearhead major regional workshops in bioethics as part of the CCTS Training Academy. They are also instrumental in enhancing a more thorough understanding of cultural sensitivity in the implementation of clinical studies and trials.

To learn more about the research initiatives and resources at Tuskegee University, click here.

Personal Perspectives On Diversity In Clinical Trials

For those of us who have not yet participated in a clinical trial, it may feel like unfamiliar territory. However, understanding what clinical trials are and why they're important for our community is critical. Clinical trials allow researchers to understand whether investigational medicines may work for people with different health conditions. It is important that people of different ages, genders, race, ethnicities, and socioeconomic backgrounds be represented in clinical research to ensure the data generated reflects the diversity of the population. However, there are many groups of people that have been historically underrepresented in clinical research, including the Black community.

If you ask Dr. Luther T. Clark, Executive Director, Patient Innovation & Engagement, Global Medical and Scientific Affairs at Merck, about the importance of clinical trials he'd say that clinical trials are "a cornerstone of progress in healthcare, helping to determine the safety and effectiveness of investigational medicines." While prostate cancer patient advocate, Euvon Jones explains, "If you're fortunate enough to be healthy, the term 'clinical trial' probably isn't part of your everyday vocabulary. You don't look it up or research it because it doesn't seem relevant. It's not that it's taboo—it just doesn't feel necessary when you're well."

They both agree that clinical trials are most impactful when they involve a diverse group of people. Dr. Clark says, "Without diverse representation, the results are not as applicable to the broader population, nor will they help address healthcare disparities, such as mortality, life expectancy or lack of access to care, which have persisted for far too long."

Real Life Representation

"When I first heard the words 'clinical trial,' I didn't know a lot about them and I knew I had some homework to do," says Euvon. "I had heard the term before and never really understood it." But he had a great connection with his oncologist whose father also had prostate cancer. "Once I learned that a clinical trial could be part of my journey, I trusted my provider to prioritize my health and quality of life. Knowing that I could trust my provider made all the difference. My oncologist could relate to my situation on a personal level. What made me even more confident was the way my oncologist involved my entire family in the process. She gave my wife and me detailed packets of information, and we made copies for our children. We all read the material together and prayed over it. That prayer support was crucial because I knew I had a big decision to make."

Looking back at his diagnosis with Stage 4 metastatic prostate cancer, nearly 14 years ago, he says he might have been upset if you'd asked him how he felt about it at the time. "But now,having walked this journey, I wouldn't trade this experience for anything in the world. It's been a profound and enlightening experience," Euvon says. "This journey has also underscored the importance of leadership and advocacy, and I'm glad to share my story and help uplift others who may be going through a similar experience."

Knowledge is PowerEuvon recalls the early part of his journey consisted of learning as much as he could about clinical trials and understanding his diagnosis. He found that talking with his doctor, loved ones and community helped him feel supported throughout his journey. Dr. Clark agrees that educating yourself about clinical trials is critical: "It's crucial that people fully understand what clinical trials are all about—their purpose, benefits, and risks. Whenpeople are well-informed and feel confident asking questions, they can make decisions about whether or not to participate in a clinical trial."

A common misconception surrounding clinical trials is the idea that participating means you're a "guinea pig." "In our community, there continues to be lingering mistrust of clinicaltrials, due to historical injustices in medical research, such as the Tuskegee Study," says Dr. Clark. "While some research studies in the past were not conducted in the most appropriate ways, modern clinical trials are conducted with strict guidelines to help protect and respect patients."

Advancing Health EquityDr. Clark and his team at Merck have made diversity and equity a foundational part of their research by creating detailed diversity action plans. "These strategic frameworks outlinespecific steps to ensure underrepresented communities are aware of and actively included in our studies. They help to promote inclusivity at every stage of the process," says Dr. Clark.

The team at Merck also focuses on listening to what patients and providers have to say and incorporating their feedback when designing clinical trials. For example, they heard some people were having challenges with accessing clinical trial locations. To help address this, Merck has brought research sites closer to communities that have historically been underrepresented in research, as well as developed programs to help with transportation barriers. Dr. Clark adds, "We've also learned that people are more comfortable with doctors who share similar backgrounds, so it's important that our investigators and clinical site teams mirror the diversity of the communities we hope to serve. We have collaborations with organizations that have been crucial in helping us reach this goal, fostering a more inclusive and representative research environment."

Creating Your Own Path"I've come to understand that the struggles I go through are not just for my own sake but to help others find their path," says Euvon. One of his wife's relatives began to reach out to him after his diagnosis, only to reveal that he himself was also diagnosed with prostate cancer. Euvon was able to share information about clinical trials and after speaking with his doctor, his relative was also able to participate in a clinical trial as well.

"If you're considering participating in a clinical trial or have questions about it, the best first step is to talk to your healthcare provider. They can provide you with detailed information about how clinical trials work, the specific trials that might be relevant to you, and what you can expect from participation," says Dr. Clark. "Your doctor can also help you understand the potential benefits and risks and guide you through the process of finding and enrolling in a trial that aligns with your needs."

Deciding whether to join a clinical trial can be challenging, but you don't have to do it alone. Click here to learn more about the importance of diversity in clinical trials and watch a panel discussion on this topic from this year's ESSENCE Fest.

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