Artificial intelligence (AI)-based clinical monitoring agents can deliver gains of up to $21m per drug development programme, as well as an 82-times return on investment (ROI), a study has found.
Analysis by Medable and Tufts Center for the Study of Drug Development (CSDD) found expected Net Present Value (eNPV) gains of approximately $7.5m for a Phase II trial, $21m for a Phase III trial and $11.3m for combined Phase II and Phase III development.
It also estimated direct operating cost reductions in on-site monitoring per clinical trial of approximately $4.4m per Phase II trial and $5.6m per Phase III study. The study found an estimated ROI of 64 times for Phase II and 82 times for Phase III clinical trials.
Additional analysis identified and valued administrative off-site monitoring task efficiencies of approximately $600,000 for Phase II and $1.7m for Phase III trials. These savings reflect clinical research associate time that could be reallocated to other studies and were not included in the eNPV calculations.
There were also effects on timelines. The analysis found that agentic AI can accelerate clinical development by approximately 18 weeks. By shortening activities on the critical path of development, agents help sponsors complete studies sooner, advancing regulatory submission and potential commercialisation while increasing the expected financial value.
This is due to reducing enrolment timelines by approximately 18 weeks, earlier database lock, and earlier realisation of future revenue and lower development costs.
Ken Getz, Tufts CSDD executive director, said: “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 enrolment and database lock timelines.”
Dr Pamela Tenaerts, CMO at Medable, said: “For a sponsor with 20 active indications, deploying a clinical monitoring agent across Phase II and III studies could generate as much as $226m in incremental portfolio eNPV. For a sponsor with 50 active indications, that figure could jump to as much as $565m. Bottom line? We now have evidence demonstrating sizeable value creation of agents in clinical research, helping break longstanding barriers.”
The findings are based on a benchmarked oncology programme, clinical trial data from Tufts CSDD and contract value and experience data from Medable.
AI becoming vital in clinical trial workflow
At the American Society for Clinical Oncology meeting (ASCO) earlier in 2026, experts highlighted a rise in the number of AI-related abstracts, with the technology being utilised at all different stages of drug development, from identifying key targets to analysing clinical data.
According to GlobalData, parent company of Clinical Trials Arena, venture financing deals involving AI have experienced more than a 400% increase between 2014 and 2024, showing how industry confidence is growing in the technology.
One of the main barriers for AI is that regulators are struggling to keep up with the pace at which the technology is advancing. This is making it challenging for sponsors to improve workflows with the technology.
