Medable, Tufts CSDD value AI gain at $21m net per programme
New analysis from the Tufts Center for the Study of Drug Development (CSDD) and Palo Alto, CA-based Medable shows that AI agents accelerate clinical trials and improve staff productivity, delivering net financial gains to a sum as high as $21 million per drug development programme, as well as 82 times the return on investment (ROI).
Medable partnered with Tufts CSDD to empirically answer the question: To what extent can clinical monitoring agents improve trial performance, and do those translate into measurable economic value for drug developers? Medable provided operational data – including operational time savings and agent cost – from its Clinical Monitoring Agent modelled in an oncology development programme. Tufts CSDD applied the expected Net Present Value (eNPV) framework, a widely accepted method for quantifying the financial impact of innovation investments, to assess the value created by the AI agent.
On average, it takes 10-12 years to bring drugs to patients. That is expected to significantly shrink for the first time in the digital age. Indeed, for the first time since 1962, the average number of drugs approved each year in the US may finally jump past 50, breaking a long-held drug development glass ceiling.
The Tufts CSDD analysis specifically assessed the impact of Medable’s Clinical Monitoring Agent across three top-line metrics: expected net present value, overall return on investment, and direct operating cost savings.
The agent showed eNPV gains of approximately $7.5 million (phase 2 trial), $11.3 million (combined phase 2 and phase 3) development, and $21 million (phase 3 trial). Meanwhile, the study found an estimated ROI of 64x for phase 2 and 82x for phase 3 clinical trials. From the data, Tufts CSDD estimated direct operating cost reductions in on-site monitoring per clinical trial of approximately $4.4 million per phase 2 and $5.6 million per phase 3 study.
Additional analysis identified and valued administrative off-site monitoring task efficiencies of approximately $600,000 (phase 2) and $1.7 million (phase 3). These savings reflect clinical research associate time that could be reallocated to other studies and were not included in the eNPV calculations.
Dr Pamela Tenaerts, chief medical officer at Medable, commented: “For a sponsor with 20 active indications, deploying a clinical monitoring agent across phase 2 and 3 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 the patent cliff race to 2030, where blockbuster drugs representing $200+ billion in annual revenue are expected to lose exclusivity, the benefits are clear.
In addition to these high-level findings, Tufts and Medable will publish a more detailed peer-reviewed paper later this year.
Dr Pamela Tenaerts previously spoke with pharmaphorum following ASCO 2025, for a conversation on the company’s digital-first model to handle long-term follow-up care for cell and gene therapy cancer trials.
