DCTs can offer net benefits ranging from five to 14 times, study says

Medable Inc., a cloud platform company for patient-centered drug development, announced results from a Tufts Center for the Study of Drug Development (CSDD) analysis, which concluded that, on average, decentralized clinical trials (DCTs) are associated with reduced clinical trial timelines, and can offer net financial benefits ranging from five to 14 times for Phase II and Phase III trials, respectively. The findings are based off of financial modeling and trial data analysis from the Tufts CSDD and Tufts University School of Medicine, along with more than 150 clinical trials enabled by Medable software.

The analysis features several findings, including:

• Shorter clinical trial times: Reductions in cycle time associated with DCT deployments had a greater impact on net financial benefits than any other factor. Nearly 85% of all clinical trials will experience some sort of delay, with the financial impact of $600,000 to $8 million per day of delay. Faster trial completion through decentralized methods can result in major cost savings.
• Lower screening failure rates: Less than 5% of the US population participates in clinical research, and up to 50% of trials are not completed because of not having enough individuals enrolled. DCTs look to shift this dynamic in order to facilitate greater patient participation, reduced time and travel burden, faster screening, more convenient consent and enrollment, and remote delivery of an intervention and the measurement of outcomes, where applicable.

“Our investigation found that, on average, the financial returns to drug sponsors from shorter development times, lower clinical trial screen failure rates and fewer clinical trial protocol amendments associated with DCTs substantially exceeded the costs of investing in DCT technologies,” explains Joseph DiMasi, director of economic analysis at Tufts CSDD.