How To Fix The Patient Diversity Problem
By Ed Miseta, Chief Editor, Clinical Leader
I recently published two articles on the lack of patient diversity that exists in clinical trials. One featured Marsha Henderson of the FDA while the other featured Luther Clark of Merck. This third piece also features a speaker from the 2016 Society for Clinical Research Sites (SCRS) Global Solutions Summit. Ola Akinboboye is a cardiologist, associate professor of clinical medicine at Weill Medical College of Cornell, and medical director of the Queens Heart Institute. He is also chair of the clinical trials division of the Association of Black Cardiologists (ABC) and has a lot of experience dealing with minority patients.
In a previous article I noted that African Americans represent 12 percent of the U.S. population but only 5 percent of trial participants. Hispanics make up 16 percent of the population but only 1 percent of trial participants. With the minority population growing in this country, non-white citizens will make up 40 percent of the nation’s population by the year 2020. By 2050, 29 percent of the U.S. population will be Hispanic.
What you may not know is that there are 38,000 zip codes in the U.S. today. Around 70 percent of African Americans reside in 2,500 of those codes, while half of Hispanics reside in 1,500 of them. These minority populations are served by approximately 500 hospitals and 40,000 primary care physicians.
Despite the concentration of these numbers, enrolling minority patients in trials remains a challenge. “When I talk to minorities, I also hear comments such as, ‘I don’t want to be a guinea pig’ or ‘I don’t really understand this process and the benefits of participating in clinical trials’” says Akinboboye. “Of course, we also have the issue of the lack of critical mass with minority physicians, particularly in research. There is also the issue of negative experiences with the healthcare system and the negative image many Americans have of the pharmaceutical industry.”
All of those factors should cause clinical researchers to worry. While the dearth of minority physicians and clinical trial participants will affect product development approvals and standard of care, there is also increasing evidence that race and ethnicity do matter in pharmacological treatments. Many new targeted therapies are targeting diseases based on genetics.
Overcome The Barriers To Diversity
Akinboboye believes the barriers to minority participation in trials falls into three categories: Patient related, research-center related, and referring-physician related.
“On the patient side, one of the biggest barriers is patient mistrust of pharma and trials,” says Akinboboye. “There is a general fear of the whole trial process and a lack of comfort with it. Many minorities do not receive adequate communication about trials and the process or simply rely on the opinions of family members. There is a stigma attached to trial participation. Time and resource constraints, transportation, logistics, and financial burden are all factors.”
While there are many factors affecting minority recruitment, dealing with the fear and mistrust is a good starting point for pharma. Akinboboye recommends first understanding that the fear and mistrust is deeply rooted in past experiences and then discussing them in an open and honest manner.
“The industry needs to help patients understand the distinction between unregulated research, which has occurred in the past (e.g. the Tuskegee study), and the fact that there are now multiple procedures in place to guarantee patient safety,” notes Akinboboye. “We also have to be careful about addressing their concerns about the impact of trials on their health, stressing that patient safety will always be the first priority. Informing patients of other studies that have been conducted with the drug can help reassure them that their safety is not in jeopardy.”
Pharma must Focus on the Message And The Messenger
Second, Akinboboye recommends pharma take a good look at the messenger being used. If pharma has a good message, selects the right messenger. This ensures the message is actually delivered and that would go a long way towards solving the issue of fear and mistrust. The message should be delivered to patients via concise and culturally sensitive educational materials about the research process and the safety aspects. The messenger should be a physician or caregiver but could also include opinion leaders in the community and racially diverse research teams. He believes these are people who can always be counted on to help move the process along.
“When I was a director of clinical research working in New York, I had a team of individuals who spoke with patients,” states Akinboboye. “I would always come in to answer any questions and get a signed consent form. In that institute 99 percent of the patient population was black, so I knew I needed to get more involved from the beginning simply because of the trust issue. The physician is the person a patient will trust, and they need to be there to help explain the entire process.”
Having a richly diverse research team on hand certainly helps. Akinboboye believes people feel more comfortable when seeing the same individuals during each visit, especially if they look like them.
Connect With Patient Families
Finally, The message has to be delivered in an open and respectful manner. Akinboboye recommends maintaining eye contact, speaking to patients in a friendly manner, and not putting any pressure on them. One thing he has learned from experience is avoiding the pitfall of allowing patients to take the consent form home to discuss with friends or family members.
“A family member will generally not say, ‘Yes, that’s a good idea. Go for it!’” says Akinboboye. “Generally, they will kill the idea. So if someone 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 financial impact to the patient, provide transportation when necessary, and have flexible schedules that include extended (evening and weekend) hours so they don’t lose work time.”
Akinboboye states site selection is critical to finding the right patients. As noted earlier, there are specific zip codes where concentrated populations of minorities live and work. Making sure there are sites in those zip codes is critical. There is often a tendency to find sites near preferred investigators, but he believes site selection should be driven by where the population of potential patients resides. Developing a working referral network can also assist with recruitment.
“And don’t forget to reassure the physicians,” warns Akinboboye. “They are concerned about losing their patients and we need to be aware of that and reassure them that no one is attempting to take those patients from them. Encourage patients to return for regular visits and resist the urge to take over management of the patient. Providing regular updates to the referring physician will also relieve some of the worry.”