By taking a research-based approach, clinical trials can become more diverse and better serve the needs of all individuals.
A lack of diversity remains one of the biggest challenges in clinical trials. According to the FDA, 76% of clinical trial participants are White, which far surpasses the racial makeup of patients from other ethnic backgrounds.1 Despite recent efforts to promote more inclusive trials, clinical trial diversity dropped to its lowest level of the decade in 2023.2
Dr. Raja M. Din, MD, leads a gastroenterology and hepatology practice in Greenbelt, Maryland.5 Dr. Din and ObjectiveHealth also lead the joint venture Mid-Atlantic GI Research, LLC, an integrated research provider conducting leading clinical research trials in gastrointestinal diseases and digestive disorders to provide patients with world-class healthcare information, support and emerging treatment options.6
A Lack of Diversity Matters
A lack of diversity in clinical trials means that broad swaths of patients are missing out on the benefits of clinical research participation — among them, access to cutting-edge treatments that aren’t yet available to the public. It also impacts the progress of clinical research itself. To receive FDA approval, clinical trials must have diverse representation ensuring that they are scientifically meaningful and representative of all populations. Given new regulatory standards for diversity in trials, drug approvals may be affected, delaying consumer access to important new therapies.
I have been a gastroenterologist in private practice for nearly 20 years. One of my goals in offering clinical research as a care option is to provide the opportunities that clinical trials offer in Prince George’s County, Maryland, one of the most diverse counties in our nation.
My patient base reflects the makeup of the community, which is predominantly African-American (approximately 64%), with additional concentrations of Hispanic and Asian residents.
Running a private practice, I always look for new ways to grow while adding services that enhance the health of my patients. While there are clinical trials in our area, offering a community-based option made a lot of sense.
Gastroenterology offers a unique blend of patient interaction and procedures. It requires a lot of trust between our practice and our patients. This trust is what makes a community clinic-based research model uniquely suited to enroll patients in clinical trials. In communities where there may be an understandable historical mistrust of clinical trials, it helps to have a recommendation from a trusted physician who can explain the parameters of the trial as well as the risks and benefits.
We have successfully enrolled patients in trials related to non-alcoholic steatohepatitis, or fatty liver disease, a hard-to-detect condition that affects roughly 50% of Americans and has a higher-than-average incidence among Hispanic populations. We are also currently enrolling patients in a biomarker study related to the detection of colon cancer, which has a higher-than-average incidence in the Black community.
Each new patient in our practice is offered a free FibroScan, an ultrasound technology that measures liver stiffness and fatty changes in the liver.3 The procedure is non-invasive and takes approximately 5 minutes. It provides useful information about a patient’s overall liver health that enables us to better treat them.
Patients participating in the biomarker studies understand that by submitting to a simple blood draw, they are participating in a study that could potentially lead to a test that can detect colon cancer, bypassing the need for a colonoscopy.
Further, not all patients will qualify for a clinical trial; however, for the ones that do, our team explains the options a clinical trial can offer related to their condition.
For me, I am always a physician first. While I am proud to offer the option of clinical trial participation, I am very careful to not make patients feel obligated to participate.
Benefits of a Clinical Trial Network
The results of these trials have been encouraging. One of the benefits of working with a national group like ObjectiveHealth is that we have partners all over the country participating in the same trials.4 While we have certainly had successes in our own practice, the real impact can be seen by looking at the aggregated numbers across sites. This is the best data that I can share with patients who have questions about our trials and how they're being conducted.
However, reaching the patients in our own practice is not enough. To really add value to our community, we have made a concerted effort to share the benefits of clinical research widely. We have the full support of our Chamber of Commerce and have built partnerships with community groups and free clinics that work with underserved populations. The ability to offer FibroScans to patients without consideration of their ability to pay makes this a popular initiative.
We take the trust of our patients seriously and are proud to offer trials that provide treatment for diseases that don’t currently have any treatment.
African-Americans are 20% more likely to die from colorectal cancer compared with Caucasians. The early detection of colon cancer can prevent death, but there are far too many people who are unable or unwilling to have colonoscopies, either out of fear or because of the limitations of their insurance. The colorectal cancer biomarker test can be a game changer for many patients, as it offers a low-cost, non-invasive alternative. While these trials remain ongoing, blood-based testing may one day offer a sound alternative to colonoscopy.
Understanding your community and their needs goes a long way to creating a successful clinical research trial program. Like any initiative that seeks to increase diversity, it must be done with authenticity and requires a commitment to the community you seek to work in. As the saying goes, trust takes years to build, seconds to break, and forever to repair.
