Clinical trial data is vital in determining treatment options for patients, and a diverse clinical trial population helps to accurately represent a city’s demographics. More than half of the Miami Cancer Institute’s clinical trial participants were Hispanic in 2019, setting the institution at the head of the curve for diversity.
While the idea of diversifying clinical trial populations is not widely practiced yet, the concept is not new. Scott Lipkin, DPM, CIP, chief research officer at Miami Cancer Institute, explained that the highest levels of the FDA have stressed the importance of clinical trial diversity to garner more accurate and effective results.
“When you think about clinical trials and clinical therapeutic research, we're testing safety and efficacy of investigational drugs and devices to see if they can be brought to market because they offer a benefit that doesn't otherwise exist,” explained Lipkin. “So, it's important to enroll a patient population that most accurately reflects the population that's most likely to use the drug or the device if it's actually approved. If we enroll a certain cohort of race or ethnicity and limit enrollment to that one cohort, we don't really fully understand the safety and effectiveness of that investigational agent throughout the entire population.”
In Miami, just about 70% of the population is Hispanic, signaling an important opportunity to health institutions to accurately reflect the city’s demographics. Incorporating a trial population that reflects the city’s population gives health professionals greater confidence in the effectiveness of that investigational drug.
Even if diversity is at the forefront of clinical trial priorities, every institution will run into challenges. Lipkin narrowed down Miami Cancer Institute’s problems to 3 main hurdles the organization actively works to overcome: study design, cost, and communication.
First, study design can create problems as it pertains to travel. Lipkin explained that most trials require the patients to visit institutes and care centers as much as once or twice a week. This can present problems with taking off from work and physically traveling to the site, among other things.
Next, treatment can be expensive for those who may not have insurance to offset standard care costs; therefore, professionals and institutions need to take financial situations into consideration. Lastly, communication barriers need to be taken into consideration when dealing with cross-language communication. Lipkin stressed the importance of investing resources in translating verbal communication as well as physical documents.
“We recognize and value the importance of enrolling our Hispanic population into our clinical studies, and we make every effort we can to make sure that we're putting resources to a place so that we can support this mission which is so important to us,” said Lipkin.
Moving forward, the Miami Cancer Institute hopes to not only maintain its commitment to diverse clinical trial populations but continue to make decisions that facilitate this development. Lipkin explained that the organization has plans over the next fiscal year to begin a community outreach program and education campaign to bring awareness to the community about the importance of a research participant and enrolling in clinical trials.
With Miami Cancer Institute seeing great success in creating a diverse trial population, other health institutions will want to follow suit. Lipkin stressed that catering the population to the demographics of that specific city is what should be atop the list of priorities when determining trial populations.
“What's important for sites, in my opinion, is to completely understand the community that they serve,” explained Lipkin. “Take a look at the number of patients who come to your facility just for standard care, just like we did at Miami Cancer Institute, and then use that as your foundation.”
For Lipkin, this is just his sixth month working with Miami Cancer Institute, which is a young, 3-year old organization itself. While the team at Miami Cancer Institute is proud of the progress to date, they understand there is still work to do.
“I think we're coming from a nice starting position, but diversity is something that's really important to us,” said Lipkin. “And I think if we had this conversation in a year, we would see that the numbers are even higher. We're going to just continue to grow in this area.”