By Ed Miseta, Chief Editor, Clinical Leader
Follow Me On Twitter @EdClinical
Pharma companies have spent years trying to deal with the issue of patient diversity in clinical trials. One study, conducted in 2015, found that 20% of new drugs demonstrated differences in exposure and/or response across racial and ethnic groups. The need for more diverse patients in clinical studies also has regulators pushing for more action on the part of pharma companies. Draft guidance released by the FDA in April 2022 is recommending that drug developers develop a plan to increase diversity in clinical trial designs they propose to the agency.
As companies look for ways to increase diversity in their patient populations, I am reminded of a presentation I attended at the 2016 SCRS Global Solutions Summit. Ola Akinboboye, a cardiologist, clinical professor of cardiology at the Donald and Barbara Zucker School of Medicine at Hofstra-Northwell, and medical director of the Queens Heart Institute, gave one of the best presentations I have heard on how to increase the participation of African Americans and other minorities in clinical research. He presented best practices on how to alleviate trial participation barriers. With the attention now being paid to diversity in trials, it seems to be a suitable time to revisit his insights.
1. Alleviate Patient Fears
Akinboboye breaks down the barriers to minority recruitment into four primary categories: Patient concerns, the message, the location of patients, and delivery of the message.
On the patient side, he believes the greatest barrier is patient mistrust of pharma and trials. He states there is a fear of the whole trial process and a general lack of comfort with it. These feelings go well beyond any knowledge they might have of the Tuskegee experiments. Many minorities have not received adequate communication about trials from nurses or physicians. That means many of them simply rely on the opinions of friends or family members. There is also a stigma attached to trial participation, and burdens such as time constraints, transportation, logistics, and monetary.
There are certainly fears that exist amongst patients considering participation in a clinical trial, and those fears are amplified in minority populations. Akinboboye noted he spoke to Black patients who stated they do not want to be guinea pigs in a trial and do not understand the benefits of participating in clinical research. Many minorities have also had negative experiences with the healthcare system or have a negative image of the pharmaceutical industry in general.
Addressing patient fear and mistrust is a good starting point for pharma in dealing with this recruitment problem. Akinboboye recommends first understanding that the fear and mistrust is deeply rooted in past experiences. Pharma will need to meet with patients and caregivers, where they live, and discuss the fears in an open and honest manner.
“The industry needs to help patients understand the distinction between unregulated research, which has occurred in the past, and the fact that there are now multiple procedures in place to guarantee patient safety,” notes Akinboboye. “We also must be careful about addressing their concerns about the impact of trials on their health, stressing that patient safety will always be the priority. Informing patients of other studies that have been conducted with the drug can help reassure them that their safety is not in jeopardy.”
2. Focus On The Message
Patient fears certainly need to be alleviated, but the barriers to successful patient recruitment go well beyond that. Akinboboye believes the next step to recruiting minority patients is placing a focus on the message and the messenger being used. A good message, delivered by the right messenger, can overcome patient fears and concerns. In fact, simply ensuring the right message is delivered can go a long way towards solving the fear and mistrust issues.
Akinboboye believes a message about the research process and the safety aspects of trials should be delivered to patients via concise and culturally sensitive educational materials. The messenger should be a physician or caregiver but could also include opinion leaders in the community and racially diverse research teams. Those are the individuals who can be counted on to effectively deliver the message.
Akinboboye once worked as director of clinical research in an institute in New York where 99% of the patient population was Black. He notes he often got involved in conversation with patients regarding trial participation and liked to get involved from the very beginning. His reason is the physician is a person the patient will trust and someone who needs to be there to explain the entire process. Having a richly diverse research team also helps, as patients prefer to talk to individuals who look like them.
Go To Where The Patients Are
If you are having difficulty recruiting patients of color, it is possible you are engaging with sites that simply do not have access to them. Today, there are more than 38,000 zip codes in the U.S. Trying to target all those zip codes would be a daunting task. However, engaging with the same sites that have not produced minority patients in the past will not change the demographic of the patients you recruit. Instead, pharma and biotech companies should target the zip codes where patients of diverse ethnic backgrounds are located.
According to Akinboboye, 70% of African Americans reside in just 2,500 of those codes, while half of all Hispanics reside in just 1,500 of them. Helping recruitment efforts even more is the fact that 500 hospitals and 40,000 primary care physicians serve those minority patients. Those numbers provide a lot of clarity to sponsors looking to recruit diverse patients.
The life sciences industry tends to be conservative when it comes to clinical trials. Companies prefer to not make a change unless it is absolutely necessary. That means when it comes to conducting study startup and site selection, companies will tend to go back to sites they have used in the past. But if pharma wants to increase its recruitment of patients of color, they will not be successful going back to the same sites that have failed to produce those patients in the past.
4. Connect With Family And Caregivers
Discussing clinical trial participation must go beyond meeting with patients. The message about clinical trials needs to be delivered in a respectful manner, while maintaining eye contact, speaking in a friendful and respectful manner, and not putting pressure on the patient. But Akinboboye believes those discussions also need to include family members and care givers.
When delivering the message of trial participation to potential patients, many will decide to take the consent form home and discuss it with friends or family members. Allowing them to do so would be a mistake.
“A family member will not say, ‘Yes, that is a good idea. Go for it!’” says Akinboboye. “More often than not, they will kill the idea. If a potential patient wants to talk to family members, you need to participate in the conversation. Have the patient bring those family members to your office or arrange a phone call with them. Some of the things you want to discuss are how you will minimize the monetary impact to the patient, provide transportation when necessary, and have flexible schedules that include evening and weekend hours, so they do not lose work time.”
Having these conversations with family members is important, but it is also important to reassure physicians. Physicians are concerned about losing their patients and need to know that trial participation will not result in a loss of patients. Sponsors, CROs, and sites can encourage patients to return to their primary care physicians for regular check ups and visits. Providing regular updates to the referring physician will also relieve some of their fears.