What You Should Know:
– New data from Tufts and Medable reveal on average, decentralized clinical trials (DCTs) are associated with reduced clinical trial timelines and can achieve net financial benefits ranging from five to 14 times for Phase II and Phase III trials, respectively.
– The findings are based on financial modeling and analysis of trial data from the Tufts Center for the Study of Drug Development (CSDD), Tufts University School of Medicine, and more than 150 clinical trials enabled by Medable software.
The drug development process is fraught with risk, high failure rates, and high costs, and if we are to meet growing unmet patient need, “the status quo is no longer a viable option.” Although many have discussed the potential for decentralized clinical trials (DCTs) to reduce the cost of drug development, until now, a demonstration of the actual benefit with a quantifiable dollar amount has been elusive. New research from Tufts CSDD, supported by Medable, Inc., a technology provider of DCT software, found substantial net benefits for the use of DCTs in drug development. An evaluation of prior industry data combined with data from more than 150 DCTs deployed on the Medable platform demonstrated that:
– In phase II studies, the typical DCT deployment for a clinical trial resulting in a 1 – 3 month time savings yields a net benefit that is up to five times greater than the upfront investment required.
– In phase III studies, a similar time savings yields a net benefit that is up to 14 times greater than the upfront investment required.
The benefits from DCT deployment that were measured and applied to the financial modeling were derived from published benchmarks on clinical trial cycle time, cost, and performance in the literature as well as conservative assumptions about the impact of, and the investment required to deploy a DCT.
“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,” said Joseph DiMasi, director of economic analysis at Tufts CSDD.
The analysis includes the following key findings:
– Net financial benefit: In phase II studies, the typical DCT deployment for a clinical trial resulting in a one-to-three-month time savings yields a net benefit that is up to five times greater than the upfront investment required. In phase III studies, a similar time savings yields a net benefit that is up to 14 times greater than the upfront investment required.
– Shorter clinical trial times: Cycle time reductions associated with DCT deployments had a substantially greater impact on net financial benefits than any other factor. Nearly 85 percent 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 methodologies can drive significant cost savings.
– Lower screening failure rates: Less than 5 percent of the U.S. population participates in clinical research, and up to 50 percent of trials are not completed because of insufficient enrollment. DCTs shift the paradigm to enable greater patient participation, reduced time and travel burden, faster screening, more convenient consent and enrollment, and in some cases, remote delivery of an intervention and the measurement of outcomes.
– Fewer protocol amendments: Protocol amendments often cause delays and dramatically increase the costs of developing new therapies. The potential for fewer research sites in a DCT leads to fewer institutional review boards and a corresponding reduction in regulatory costs and increased flexibility around protocol changes.
High-level findings of the analysis were published today. The researchers will submit a more detailed paper for publication later this year, detailing how Tufts CSDD calculated net financial benefits as well as additional details on the assumptions and calculations used in the analysis. The study is one of the first to provide quantifiable evidence for the value of DCTs.
“Drug development is overly complex, expensive and time-consuming, delaying access to new medical products and safe and effective treatments becoming available to patients,” said Dr. Pamela Tenaerts, Chief Scientific Officer at Medable. “We must reverse these trends and use funds efficiently and effectively to improve evidence generation in drug development, thereby helping to improve patient lives. Decentralized trials are an increasingly important and evolving part of this landscape. We trust that these findings and future research on DCT implementation will help promote more innovation; decreasing the cost and increasing the pace of drug discovery.”
For more details, download the report here.