Decentralized clinical trials (DCTs) are showing promise in enhancing the diversity of participant populations, according to new data from the Tufts Center for the Study of Drug Development (CSDD). The research, part of the PACT Consortium study, indicates that DCT approaches are linked to notably higher proportional representation among specific demographic subgroups.
The analysis, which encompassed 69 clinical trials, revealed that 20.9% of participants in DCT-enabled trials identified as Asian, compared to just 14.2% in traditional trials. Furthermore, the representation of indigenous communities (American Indian and Alaska Native) nearly quadrupled, rising from 0.5% in traditional trials to 1.9% in DCTs. Female participation also saw a significant increase, climbing from 49.0% to 55.7% in DCTs.
Strategic Implementation is Key
Ken Getz, Executive Director of Tufts CSDD, emphasized the importance of a strategic and intentional approach to improving diversity in clinical trials. "The results show that DCT component use in clinical trials is associated with improvements in proportional representation by race and ethnicity, but there is still wide variation in patient preferences, by disease condition, and by the type of DCT component deployed," Getz stated. He also noted that certain decentralized elements, such as local labs, have been associated with significantly higher representation among Black participants, underscoring the need for tailored solutions.
The Role of the PACT Consortium
The Partnership for the Advancement of Clinical Trials (PACT) Consortium, managed by Tufts CSDD and supported by over 30 pharmaceutical organizations and technology providers like Medable, AbbVie, Amgen, Gilead, Novartis, and Roche Genentech, aims to provide a data-driven blueprint for action in the industry. The consortium also receives oversight and expertise from the NIH, FDA, and National Cancer Institute.
Future Directions
Dr. Pamela Tenaerts, Chief Scientific Officer at Medable and a founding member of the PACT Consortium, highlighted the ongoing efforts to expand the scope of the research. "The first year we focused on creating consensus on definitions and gathering as many trials as possible – now, close to 70 – and hope to double that next year," Tenaerts said. She added that Medable is committed to investing in evidence-generation to uncover the best ways to apply technology for significant impact on research.
While DCTs have shown success in boosting representation among certain groups, the study also revealed that the proportional representation of Black or African American participants did not significantly improve with DCT implementation. This highlights the need for continued efforts to address the specific barriers to participation faced by this community. Further research is needed to identify and implement targeted strategies to ensure equitable access to clinical trials for all populations.
