You may have heard that April is Minority Health Month. It’s a month for us to dig into how we can be as inclusive as possible in health and medicine – and to devise strategies to address this year’s theme: “Bridging Health Equity Across Communities.” One area where health inequity is stark is in participation in clinical research. Even though, according to Genome Magazine, research centers in diverse areas are required to include 60% of patients from minority groups, and those in less diverse areas are required to include at least 25% from diverse backgrounds, the national average proportion of minority patients in clinical trials is estimated at around 10% (and some say that’s a high estimate). This matters.
To share thoughts on why, we interviewed Regina Greer-Smith, MPH, LFACHE, the President of Healthcare Research Associates, LLC. Regina has been a lifelong community activist focused on healthcare, social justice, and research. Regina has harnessed that passion in the research space by getting involved as a PCORI (Patient-Centered Outcomes Research Institute) patient engagement research activist. Her mission is to increase the participation rate of minorities and underserved communities in patient-centered outcomes research (PCOR), comparatives effectiveness research (CER), and now clinical trials.
We know that minorities are underrepresented in clinical research. Can you talk a little bit about why this is?
There are certainly low participation rates, and it’s important to understand the reasons for this in order to address them. One of the key reasons is that people in minority and underrepresented communities lack trust in medical research and the healthcare system. The trust is broken because of historical harm, specifically to the African American and Latino communities. Look at instances such as the US Public Health Service’s Tuskegee Syphilis Study or Tuskegee Syphilis Experiment in which African American men weren’t told they had syphilis and treatment was withheld to observe the natural course of the disease. It’s really no wonder our communities are skeptical of research and clinical trials, even today. It’s ingrained in us. When I brought up research to my community, it was tough. It took me nearly two years to rebuild that trust and begin conversations on the possible benefits of research and clinical trials. That’s how powerful the mindset is.
Another key reason is that many trials are conducted out of academic research centers in large urban areas, and African Americans don’t normally get their care from these centers. So, they aren’t told about these opportunities simply because they aren’t in the right place at the right time. Others assume – based on no data, by the way – that African Americans will not be compliant in clinical trials. In general, even beyond where a person is treated or what might be expected of them, the engagement hasn’t been there. Many people don’t know much about clinical trials, and the effort to educate is still just beginning. It’s important to note that statistics show that when minorities are given the opportunity to take part, and provided with all the necessary information, and trust is built, there is a high percentage interested in participating in research.
With President Obama’s Precision Medicine Initiative and the FDA declaring 2016 “the year of diversity in clinical trials,” the push to increase minority participation has been accelerated. The drive for more engagement and enrollment in clinical trials means that all Americans may finally benefit from research.
What about the fact that there are fewer minority researchers? Do you think that plays in?
Yes, that is absolutely correct. We learn in the delivery of healthcare is that populations tend to want to get care or treatment from people that look like them, so that’s certainly a factor too. I’m pleased that there are several initiatives to train minority researchers happening now in addition to the work being done to educate patients.
Can you talk a little bit about the role of government here? You mentioned that the FDA and the White House have been really pushing for this. What are your thoughts on that approach?
I think it’s great, in fact I put that tagline, “the year of diversity in clinical trials,” in my email signature all year. Having this message come from these powerful organizations gave it real credibility and people paid attention to it. In my experience, there have been a lot more conversations around this topic since then.
Is there anyone tackling this issue particularly well?
Yes, PCORI is funding research and engagement projects around inclusion in PCOR and CER – not only increasing the minority participation but also requiring their participation in the design, implementation, and dissemination as well. PCORI has a stated particular interest in “priority populations,” and that covers a variety of minority and underrepresented communities such as the elderly, LGBTQ, and rural communities.
Can you talk a little bit about your work to solve the problem of inclusion in clinical trials?
I am so proud of and humbled by a program I designed called the S.T.A.R. Initiative. It was designed to match minority communities with researchers, and it won when I submitted it as part of a challenge that PCORI and Health 2.0 held in 2013. From there, I started my work spreading the word, and the places where my message resonated the most was black churches. Our project, Pastors4PCOR developed a curriculum for faith-based communities to do research, and the response was remarkable. Pastors took up the mantle and it was amazing to see. We developed “research ministries” headed up by our ” research ministry ambassadors” or RMA, who are now community scientists. Each RMA participated in our five-module training program, which included certification in human subjects protections. We developed and delivered surveys, and collected data on our work and the data belongs to the community – it’s all open. Pastors4PCOR is now a 501(c)(3). As a result of this work, we have received more funding and opportunity to work with an academic center on a national pragmatic study. I have to say I am very grateful to have been introduced to PCORI by a woman named Sue Sheridan –she was PCORI’s first Director of Patient Engagement. I answered my phone when she called – I never answer my phone! But I’m so glad I did because it’s been transformational.
I always tell folks, engagement is a journey. You just cannot call or invite someone to be part of a trial. You need to already have relationships and trust. And we need to continue to push. More people have to get involved with PCORI. These messages of inclusion have begun to become embedded in the research and the research industry – now I’m looking for pharma to follow suit. We also need younger doctors and researchers to be on board as well. The legacy of civil rights needs to be reactivated, both the methodology and that spirit. The community has to become reactivated as well; they are the beneficiaries of the research and much of it they fund with their taxes. So, we continue to push for that education. Not everyone has to be an expert, but awareness can go a long way to ensuring that all are included in medical research.