The Covid-19 pandemic and the disproportionate devastation it has wrought on Black, Hispanic, and poor Americans has (again) raised the call for creating inclusive clinical trials that are representative of patient populations. That’s an important goal, but it’s easier said than done.
I work as a patient advocate for Eidos Therapeutics, a biotech company focused on developing a treatment for transthyretin amyloidosis, an underrecognized cause of heart failure with a disproportionate racial impact due to a disease-causing mutation found in 3% to 4% of Black Americans. Part of my job is to help recruit Black and other underrepresented minority participants for clinical trials. I’ve seen the challenges of recruiting Black people to take part in clinical trials, but I’ve also seen how successful it can be.
It’s necessary work. Unless clinical trial participants represent the people who will be using a new therapy, then we can’t know how it will work for those who need it the most. Cardiovascular disease is a good example: Even though heart conditions disproportionately affect Black individuals, they accounted for only 2.5% of clinical trial participants in a global trials report by the Food and Drug Administration.
What’s more, physicians may be reluctant to prescribe new medicines to Black people if investigational trials did not include them, even for diseases such as sickle cell disease or hereditary transthyretin amyloidosis that affect Black people more than others.
I’ve found that one of the first and most important steps to creating an inclusive clinical trial is to engage the target community in discussions around the recruitment plan. By bringing these communities to the table early, we can hear their input instead of making assumptions about how to best reach them. We can hear their concerns and attempt to address them, while educating the communities about the importance of clinical trials, all that’s involved, and the potential to bring high-quality care to their community.
One way to accomplish this is by engaging with community education programs, such as those sponsored by church groups. Eidos partners with the Association of Black Cardiologists to help us understand where our target audiences spend their time and who they trust. With this information, educational opportunities can be established for people to learn in safe places. Approaching trial outreach through tight-knit community groups gives potential participants and their family members an opportunity to learn about information they would have never been exposed to, all from the people they trust.
One of the successful tactics I’ve used to help recruit older Black participants for clinical trials is to engage the younger generation. The family unit is important in the Black community. One obvious place to start is reaching out to historically Black fraternities and sororities. These organized groups of educated, social-minded individuals are looking to give back to their communities and can act as bridges to their parents, grandparents, and the Black community more broadly.
In the Black community, elders often trust younger family members on matters of health, and the younger generation is protective of their elders, so these types of initiatives recognize the dynamics of Black culture and work within those cultural dynamics.
Beyond reaching out to Black people in the U.S., looking overseas to engage individuals of African descent is another option. That can open the door to countries in Africa, as well as in Brazil and elsewhere in Latin America, where Black populations may welcome the opportunity to participate in trials, which can then be more inclusive thanks to their participation.
Engaging investigators is another important strategy. Even simple tactics, like giving physician-investigators a goal for the number of Black participants they recruit, can help fill a clinical trial with a representative population. That’s what the National Institutes of Health does — it says it wants a representative population, and that’s what it gets. Data that represent the racial breakdown in NIH-funded clinical research since 2015 show that there has been a significant increase in the number of Black participants over the last five years. While these trials are still not fully representative (notably of other minority groups), it is an improvement.
Another piece of the puzzle is physician representation at trial sites. Black patients like to see Black doctors, so they should be among the investigators. At trial sites where this is not an option, it’s helpful to include other Black staff members who can meet with patients in addition to the investigator.
While it’s important to recruit Black participants for clinical trials, it’s also important to understand and overcome the barriers to keeping them enrolled. Once enrolled, Black participants tend to drop out of trials at a higher rate than other groups. Based on my work with Black participants, I feel that one reason for this is that some may not be used to people trying to accommodate them, even around basic items like scheduling. Clinical trial sponsors are keenly interested in ensuring their participants stay on protocol, and so are very accommodating to individuals’ needs. But that message can get lost. If trial participants don’t know to speak up and say they need accommodations around, for example, child care, transportation, or scheduling issues, they’re more likely to drop out. To run a successful inclusive trial, investigators need to encourage participants to be vocal about what they need and then explain how investigators and clinical trial sponsors can help.
Another reason typical clinical trial recruitment strategies often don’t extend to Black participants is the repeated use of certain trial criteria and sites. When planning trials, companies tend to use similar guidelines and work with the same clinical sites time and time again. Establishing trial sites at clinics and medical centers with significant minority populations is a good place to start.
Even when creating criteria for a study, something as simple as carrying over the commonly used target blood pressure level can exclude large portions of racial groups from participation. On average, Black people tend to have higher blood pressure compared to those of European descent. Not adjusting for that difference can lead to inadvertently excluding Black patients from many studies. We must do a better job of looking outside the typical clinical trial site repertoire or reading over exclusion criteria with fresh sets of eyes.
Unconscious bias within the medical community can also hinder trial recruitment. Physicians may not even think to suggest to their patients of color that a clinical trial is an option if they assume their patients are not interested or have a negative perception of clinical trials. Training works to help physicians and investigators think past their biases, proactively encourage their Black patients who might qualify for clinical trials to participate, help educate them about the process and the clinical studies, and make it clear that patients should never be afraid to ask questions.
As many of us in biotech and pharma push for more equal representation across our industry, we need to ensure that it’s a priority in our clinical trials as well. With the right focus and commitment, clinical trials can and should be inclusive, leading to improved studies and access to experimental medicines for more Black patients.
Jocelyn Ashford is the director of patient advocacy at Eidos Therapeutics, a BridgeBio company.
Article does not mention at all that Males are even more under represented per capita death/severe consequence than females in the studies, than the (claimed but not shown) putative underrepresented of blacks compared to Whites.
(Yes the capitalization above is a satire of the meaningless affectation in this article)
The writer states “black people like to see black doctors” …. why then all the commotion over white people preferring white doctors? And from prior Will and Gerald’s replies to this article, blacks (and hispanics) are very well represented in trials. It appears even to be the opposite: whites could be under-represented …… I am getting a little fed up with this bias baloney.
This data may reflect the world but not the US. I have participated in 61 studies in 14 years and the numbers in those studies is close to 60% African American. Hispanics in the study I am currently in makes up half of the male population of the clinical trial
I am a volunteer and payed clinical trial participant at 6 different locations. I disagree, at least at these 6. The black community is well represented.
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