Parexel is teaming up with Signify Health to better understand the diversity of patients in clinical trials and re-model their studies accordingly.
The new partnership will focus on “improving patient access to clinical trials, bringing studies to patients in their own homes, and identifying relevant social determinants of health (SDoH) to facilitate connections among local resources, patients, and caregivers,” according to a statement.
Exact practical details of how this will work have not yet been made public, and the pair said they will find a way forward over the next few months.
The problem of diversity in clinical trials is a major, ongoing issue and one that has become more prominent and public amid the swathe of COVID-19 vaccine and drug trials, many of which were not representing enough of the patients who were most at risk of severe disease or death.
This summer, researchers called out Gilead Sciences for failing to “provide equal representation of Black, Latinx and Native Americans” in its clinical trials for Veklury, the first FDA-approved treatment for COVID-19.
The researchers analyzed the demographics of several data sets for the drug, also known as remdesivir, finding that Black Americans made up 11% of the participants in a 397-patient study and 20% of a larger study involving more than 1,000 patients.
Those figures don’t look too shabby next to national demographics, where Black Americans make up about 13% of the U.S. population. But they fall short in a pandemic that has disproportionately affected Black people and other people of color.
In Alabama, for instance, Black or African American people comprise 27% of the population but account for 43% of COVID-19 cases. Hispanic or Latinx people are also overrepresented in COVID-19 case data in Alabama and other states.
Parexel alongside Signify Health are now hoping to be at the forefront of a change in this. “Simply saying clinical trial diversity is ‘important’ is not enough,” said Peyton Howell, executive vice president and chief commercial and strategy officer for Parexel.
“To correct the disparities in healthcare and drive more inclusion in clinical trials, we first must achieve a more holistic understanding of the non-medical factors that influence patient lives. Signify Health’s analytics and technology platform will enable us to use these insights to better understand the social and societal factors impacting inclusion—a key requirement to ensuring diversity in clinical trials.”
Other companies have over the past year made similar pledges, with Bristol Myers Squibb saying in November that, fueled by COVID-19 and social justice movement, it too will be ramping up diversity efforts in clinical trials.
“Through our mobile, national network of providers, we already have activated the home as an alternative site for baseline patient assessments and first dose observation for specialty drugs,” added Signify Health CEO Kyle Armbrester.
“Alongside this clinical support, we are identifying and addressing the social comorbidities that impact a person’s ability to access the care they need. It is particularly exciting to be working with Parexel on ways to leverage these capabilities to support both patients, and their caregivers, who want to participate in clinical trial programs for potentially life-changing therapies.”
As part of the pact, the pair said that, over the “coming months,” they will both “explore opportunities to address social determinants of health issues as part of the clinical trials recruitment and management processes with the intention of initiating their first pilot program during the first half of 2021.”