Working to Achieve Diversity in Clinical Research
By Laura Freeman
The human body is an amazing organism, and in the millions of years since we became distinct from our nearest mammalian ancestors, we've adapted in many different directions.
Though as a species we have much in common, it should come as no surprise that on a biological level, our bodies can respond very differently to the same substance. This is one of the primary difficulties in developing treatments that will be both safe and effective in a broad range of patients from different backgrounds.
Clinical testing is the proving ground where medical researchers look for data to determine if a drug works and is safe. To draw valid conclusions, a study is only as good as it is representative of the patients who will ultimately be using the treatment.
As the format of clinical trials became established in the middle of the 20th Century, cultural norms of the period had an unfortunate influence on the attempt to gather representative data. Subjects recruited for trials tended to be exclusively adult white men. The idea of including women in clinical trials unrelated to obstetrics or gynecology wasn't considered and ethnic minorities were essentially invisible.
Since that time, the situation has improved dramatically for women's roles in clinical trials. However, recruiting a representative sample of ethnic minorities, particularly those of African American descent, has been difficult.
"Several things contribute to the low African American participation in studies," Monica Baskin, PhD, professor of preventive medicine and associate director of community outreach at UAB's O'Neal Comprehensive Cancer Center, said. "To begin with, there is a lingering distrust of medical research left over from situations like the Tuskegee experiment.
"In addition to the distrust factor, some studies have structural barriers in their design. For example, to give their drugs the best opportunity for success, pharmaceutical companies frequently have exclusions of people with common chronic conditions. People with African American ancestry are more likely to have co-morbidities such as hypertension, diabetes or obesity that rule them out before they ever have a chance to participate. We're working with pharmaceutical companies to better define restrictions to things that truly matter, so that more diverse participation is possible."
In the past few decades, recruiting participation from this gene pool has been a priority for the National Cancer Institute. African American ancestry includes several genes that are linked to different responses to blood thinners, eye medications and other drugs, as well as conditions like Sickle Cell disease. It is imperative that diversity in clinical testing mirror the population who will be using the drug to detect side effects and responses specific to genetic differences.
In spite of concerted efforts, recruiting African American participation in clinical trials still lags behind. "Part of the difficulty is that African American populations aren't necessarily concentrated in areas near clinical trials," Baskin said. "There is a higher concentration in the south. A large number of Alabama's African American families live in underserved rural areas where transportation is an issue and people may not be able to take off work to see a doctor or spend time driving a long distance.
"The financial side of access to care can also be difficult. Until recently, many African Americans didn't have health insurance or the means to seek care except in a serious emergency.
"The unconscious bias of Physicians can be an issue, as well. If they assume that participating in a clinical trial may be too difficult for patients due to transportation issues, work schedules or financial limitations, they may not mention a trial that might otherwise be helpful.
"Our Physicians at the O'Neal Comprehensive Cancer Center wear buttons that say, 'Ask me about clinical trials.' We want patients to know we have ongoing trial that might be beneficial. We've also updated our website with a searchable database so it's easier to find the trials available here and determine whether they might be a good fit.
"If we don't have a trial related to their condition here, we will help patients look for a trial in other places that they might qualify for that could be beneficial. We're also putting an effort into making sure that when they come here, they see more medical professionals who look like them and they can be comfortable interacting with the people providing their care."
Baskin and her team are working to get the word out in the community through civic and social organizations and churches. "We want them to know that by participating, they will be helping other African Americans who will be taking these medications and treatments in the future," she said. "They may also be helping themselves through early access to a treatment that could make a difference."