A new Tufts Center for the Study of Drug Development (CSDD) analysis shows that an AI clinical monitoring agent can deliver net financial gains as high as $21 million per drug development program and 82 times the return on investment.
The findings are based on benchmarked oncology program and clinical trial data from Tufts CSDD and contract value data from Medable, which provides a cloud-based software platform designed to modernize and accelerate clinical trials for the pharma and life sciences industries.
Tufts CSDD officials believe that the study marks the first time that eNPV modeling based on actual use and benchmark data has been applied to quantify the net financial impact of an agentic AI solution deployed to support a drug development program. [Prime Images/Getty Images]The Tufts CSDD analysis specifically assessed the impact of Medable’s Clinical Monitoring Agent across three top-line metrics:
Expected net present value: The agent showed expected net present value (eNPV) gains of approximately $7.5 million (Phase II trial), $11.3 million (combined Phase II and Phase III) development, and $21 million (Phase III trial).
Overall return on investment: The study found an estimated ROI of 64x for Phase II and 82x for Phase III clinical trials.
Direct operating cost savings: Tufts CSDD estimated direct operating cost reductions in on-site monitoring per clinical trial of approximately $4.4 million per Phase II and $5.6 million per Phase III study.
“To our knowledge, this is the first time that eNPV modeling based on actual use and benchmark data has been applied to quantify the net financial impact of an agentic AI solution deployed to support a drug development program,” said Ken Getz, Tufts CSDD executive director. “The financial value created by the investment and deployment of the monitoring agent was driven by operational efficiencies such as the reduction in the number of on-site visits and reduced travel costs as well as accelerated enrollment and database lock timelines.”
Additional analysis identified and valued administrative off-site monitoring task efficiencies of approximately $600,000 (Phase II) and $1.7 million (Phase III). These savings reflect clinical research associate time that could be reallocated to other studies and were not included in the eNPV calculations.
The analysis also found that agentic AI can accelerate clinical development by approximately 10 weeks. By shortening activities on the critical path of development, agents help sponsors complete studies sooner, advancing regulatory submission and potential commercialization while increasing the expected financial value, according to the study.
Key contributors include faster patient enrollment, reducing enrollment timelines by approximately 109–119 days, earlier database lock, shortening closeout activities by about two weeks, and earlier realization of future revenue and lower development costs.
“The potential impact is magnified when applied across a large oncology portfolio,” said Pamela Tenaerts, MD, chief medical officer at Medable. “For a sponsor with 20 active indications, deploying a clinical monitoring agent across Phase II and III studies could generate as much as $226 million in incremental portfolio eNPV.
“For a sponsor with 50 active indications, that figure could jump to as much as $565 million. Bottom line? We now have evidence demonstrating sizable value creation of agents in clinical research, helping break longstanding barriers.”
In addition to these high-level findings, Tufts and Medable will publish a more detailed peer-reviewed paper later this year. Sign-up to be the first to receive the final published paper here.
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