Policy & Regulation
Decentralized Clinical Trials Can Achieve Net Financial Benefits of 5X to 14X, Due to Reduced Trial Timelines and Other Factors, Study Finds
14 January 2022 - - US-based cloud platform for drug development Medable Inc has posted results from a Tufts CSDD analysis which shows that, on average, decentralized clinical trials 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.

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.

Cycle time reductions associated with DCT deployments had a substantially 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 USD 600,000 to USD 8m per day of delay. Faster trial completion through decentralized methodologies can drive significant cost savings.

Less than 5% of the US population participates in clinical research, and up to 50% 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.

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.

In addition to the Tufts CSDD high level findings, Medable also published its annual "Medable Matters: 2021 Impact Report," detailing the company's progress, learnings and insights from 2021.

Medable is on a mission to get effective therapies to patients faster by transforming clinical drug development with disruptive technologies.

The company's digital platform streamlines design, recruitment, retention and data quality for decentralized trials, replacing siloed systems with integrated digital tools, data and interfaces to accelerate trial execution.

Medable connects patients, sites and clinical trial teams to improve patient access, experience, and outcomes. Medable is a privately held, venture-backed company headquartered in Palo Alto, California.