Researchers seek new ways to broaden clinical trial enrollment

In January, Parexel, a contract research organization that provides drugmakers with clinical trial supports like patient management, hired the company’s first chief patient officer as a means of enhancing clinical trial diversity.

A spokeswoman for Johnson & Johnson, which is developing a singledose coronavirus vaccine through its subsidiary Janssen Pharmaceuticals, said the company has launched several of its own initiatives, including a webinar program to educate pharmacists on the importance of participation diversity as well as a series of community outreach sessions to answer patients questions about clinical trials.

Last November, the Food and Drug Administration released guidance calling for industry stakeholders to address challenges in enrolling patients from underserved communities.

Actions the agency suggested to drugmakers included reducing transportation burdens by either providing patients assistance to get to clinic visits or by reducing their number of visits, broadening clinical trial enrollment eligibility criteria, and working with patient advocacy organizations.

“Simply saying clinical trial diversity is ‘important’ is not enough,” said Peyton Howell, Parexel’s executive vice president and chief commercial and strategy officer, in a statement. “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.”

Also in January, Parexel announced it was partnering with Signify Health on a new initiative to improve patient diversity in clinical trials by identifying social needs that might inhibit minorities from participating in studies and connecting them with local resources.