CRO

Using decentralized trials improves patient diversity, industry-backed study finds

Decentralized clinical trials, which allow patients to participate locally or remotely using digital tech, enroll more diverse populations than traditional trials, according to new data from the Tufts Center for the Study of Drug Development’s (CSDD's) PACT consortium. 

The analysis of 69 trials found that decentralized trials featured greater representation of Asian, American Indian or Alaska Native people as well as female participants compared to traditional trials. 

Asian representation climbed from 14.2% for traditional trials to 20.9% for DCTs, according to the analysis, while American Indian or Alaska Native participation nearly quadrupled from 0.5% to 1.9%. 

PACT backer Medable shared the data in a Jan. 28 release.

Female participation rose from 49% for traditional trials to 55.7% for DCTs, according to the release, but participation by Black or African American patients stayed the same at 7.3%.

“Increasing diversity in clinical trials requires a multifaceted approach rather than a monolithic one,” Ken Getz, executive director of the Tufts CSDD, said in the release. “In our research, we see certain decentralized elements, like local labs, can dramatically boost enrollment among Black participants so you must be intentional when applying DCT solutions. It’s not one size fits all.”

The PACT consortium consists of more than 30 biopharma organizations and seeks to study the effect of decentralization on clinical trial performance, according to its website. Other backers of the PACT consortium include pharma giants like Bristol Myers Squibb, AbbVie, Pfizer and Novartis, according to the release, with federal agencies like the National Institutes of Health (NIH) and the FDA providing oversight and expertise.

Meanwhile, the future of federal clinical trial diversity initiatives was thrown into flux recently after the Trump administration unveiled plans to eliminate diversity, equity and inclusion programs throughout the government.

The order led to the FDA’s guidance detailing diversity action plans for clinical trials being taken down from the agency’s website, with similar pages from the websites of the NIH, the National Cancer Institute, the National Institute of Allergy and Infectious Diseases and the Oncology Center of Excellence also being removed.