In order to bolster clinical trial diversity, we first have to understand the existing barriers that prevent it.
When the racial, gender, or ethnic makeup of a clinical trial’s participants isn’t representative of the population at large, it’s difficult to determine the efficacy and/or potential side effects of a new drug, therapy, or device. Recognizing this fact, the FDA is placing an increased emphasis on patient population diversity in clinical studies.
Of course, clinical trial recruitment is already a significant pain point for the industry. This initiative, while clearly warranted, further complicates an already challenging process, as many of these patients are, in fact, the most difficult to enroll. Ethnic minorities tend to have lower incomes, and research suggests that there’s a direct link between a patient’s income and their willingness and/or ability to participate in a clinical trial. In fact, in a recent survey, the National Cancer Institute Community Oncology Research Program found that members of households earning less than $50,000 per year were far less likely to participate than those earning more.
By examining and understanding the common socioeconomic and cultural barriers that prevent these patients from enrolling and ultimately remaining in clinical studies, sponsors and CROs can develop better solutions for reaching, engaging, and accommodating those patients throughout the entire process. Below, I’ve outlined four of the most common issues that get in the way of clinical trial diversity.
1. Unmet Needs
Patients from of low socioeconomic status are often unable to participate in clinical trials because of unmet needs like transportation, meals, and day care for their children. This can be a serious problem for trials that require patients to travel frequently to investigator sites for in-person check ups.
In response to this problem, some sponsors and CROs are partnering with ridesharing companies like Uber and Lyft to transport participants to and from investigator sites. For less mobile patients, solutions like homecare, remote patient monitoring, and sensor technologies can help improve retention, adherence, and the overall patient experience.
2. Fear or Distrust
Ethnic communities — and especially African-Americans — have a complicated relationship with doctors and medicine, to say the least. Deceptive studies like the Tuskegee experiment and historical mistreatment of minority groups in medicine have made people reluctant to volunteer themselves for clinical trials. To combat this, trial organizers must earn the trust of the communities they hope to work with.
One of the best ways to develop that trust is to allow potential participants to meet with trial organizers in person. In one study, researchers found that face-to-face interaction with prospective patients yielded the highest enrollment rate and the lowest rate of attrition. When travel isn’t an option, telehealth technologies can help investigator site staff meet patients face-to-face, develop a trusting relationship early on, and increase the number of minority participants in their trials.
3. Inadequate Recruiting
It’s difficult to recruit specific patient demographics when your advertising materials aren’t actually reaching them. Many organizers comb through medical records or national databases to find patients, but because minority groups, on average, have poorer access to care, this approach often leads to qualified African American and Latino participants slipping through the cracks.
Today, digital media is undeniably the best way to connect with any target audience, regardless of how specific the inclusion/exclusion criteria. For example, Facebook’s advertising platform includes an “ethnic affinity” targeting option, which can be utilized to reach specific demographics with personalized materials. Similarly, a diabetes-related trial looking to reach Latino participants could use Google AdWords to target patients conducting condition-specific searches in spanish, or within a primarily Latino neighborhood.
4. Poor Communication
Inadequate communication about the details of a specific procedure or treatment, as well as trials in general, is another significant barrier to minority patient recruitment. Advertising and/or informational materials should be translated into multiple languages and tailored to be culturally relevant for the groups being targeted. One simple, cost-effective is to develop digital advertising campaigns in multiple languages, which will help to ensure the message reaches the intended audience and that it resonates when it does. Similarly, it’s important to ensure that call center and investigator site staff has the capacity to work with non-english speaking patients.
While things are certainly improving, the industry still has a long way to go when it comes to increasing patient diversity in clinical trials. Luckily, technology may be able to help bridge the divide, enabling sponsors to adapt to new FDA guidelines, speed up approval times, and ensure that every patient has access to the vital, new treatments they need and deserve.