Clinical trial participation should reflect the patient population affected by the disease but in many cases representation falls short. AbbVie's head of diversity and patient inclusion looks at what needs to be done to progress future clinical research efforts.
The world relies on clinical trials to evaluate how safe and effective drugs are before they go to market. But efficacy can vary based on age, race, ethnicity, sex, or other intrinsic factors. This is why diversity matters in clinical research – yet it often isn’t seen.
The challenge is a long standing one, but recent events like the COVID pandemic, social justice movements, and the release of 2020 guidelines by the Food and Drug Administration (FDA) have shined a spotlight on the disparities that persist within clinical trials and other areas of health care.
“Seeing how the pandemic disproportionately impacted Black and Hispanic communities has really brought more attention around the health equities that are embedded across our health care system, and this is galvanizing people to make a more concerted effort to address them,” said Kim Ribeiro, head of diversity and patient inclusion at AbbVie. “For those of us within the pharmaceutical industry, this is an opportunity to revisit why this is still a problem and what we can do differently.”
The time and resource constraints are among the most common barriers to patient engagement in clinical research.
“While everything else in society is pretty much on-demand, clinical trials are one of the few areas where we’re often asking the patient to come to us. For participants, this may involve taking time off work, traveling and spending long hours at the study site. That’s a hard sell for anyone, especially those who don’t have the luxury of working remotely,” Ribeiro said.
AbbVie worked to address these kinds of barriers while studying uterine fibroids in African American women. In the study, the clinical team had to collect sanitary products participants had used, every single month for over a year. To make the process easier, trial conductors offered transportation assistance, stayed open late and gave patients reminders through a mobile app. These efforts helped keep women on the trial for more than two years.
On top of logistical barriers, emotional barriers persist when it comes to enrolling people in trials. These types of barriers may be fueled by a misunderstanding of the value of clinical trials, mistrust in the medical industry or other misperceptions.
"A lot of times when you talk to patients about considering a clinical trial, it’s very easy for them to articulate the logistical barriers, but emotional barriers are more nuanced," says Sasha Tyndale, director, patient engagement and inclusion solutions, AbbVie.