WAYNE, PA — Clinical trial sponsors using risk-based quality management (RBQM) may shorten oncology trial timelines by as much as 19% while generating returns of up to 23 times their investment, according to newly published research that quantifies the financial impact of the increasingly adopted oversight approach.
The findings, published in the journal Therapeutic Innovation & Regulatory Science, were developed by researchers from Wayne-based CluePoints and the Tufts Center for the Study of Drug Development (CSDD). The study examined whether RBQM, an approach that uses statistical analysis and artificial intelligence to identify trial risks, delivers measurable financial benefits beyond regulatory compliance.
The analysis combined data from 18 oncology trials conducted using the CluePoints platform with oncology development benchmarks maintained by Tufts CSDD. Researchers modeled the financial effects of RBQM across multiple stages of clinical development, including monitoring costs, development timelines, probability of success and projected commercial performance.
The study found RBQM-enabled trials were associated with reductions in clinical phase durations ranging from 8% to 19%.
At the individual trial level, estimated financial returns ranged from $3.2 million in Phase 1 studies to $18.9 million in Phase 3 trials, representing returns of six to 23 times the investment.
Across broader drug development programs, researchers estimated gains in expected net present value ranging from $3.8 million in Phase 1 to $13.8 million in Phase 3, corresponding to returns of four to 14 times the investment.
The study concluded that shorter development timelines accounted for most of the financial benefit, outweighing savings from reduced monitoring costs.
The research also identified operational benefits associated with RBQM-supported oversight, including earlier identification of trial risks, improved data quality oversight, more efficient allocation of monitoring resources and increased development efficiency.
Kenneth McFarlane, vice president of strategic consulting at CluePoints and a co-author of the study, said the findings provide quantitative support for organizations evaluating broader adoption of RBQM.
“For many sponsors, the question is no longer whether RBQM is aligned with regulatory expectations or good clinical practice — it is how to justify investment and scale adoption across portfolios,” McFarlane said. “The fact that most of the financial value was driven by time savings is especially important, because protecting development timelines is one of the most strategic levers sponsors have.”
The paper was co-authored by CluePoints researchers Sylviane de Viron and McFarlane alongside Abigail Dirks and Kenneth Getz of Tufts CSDD.
Dirks said the analysis provides an evidence-based framework for estimating RBQM’s financial value while noting the model did not include potential savings from reduced rework, improved data integrity, inspection readiness or training costs.
According to the company, the research addresses a longstanding industry gap by providing quantitative evidence of the economic impact of RBQM as the pharmaceutical industry increasingly adopts the framework alongside updated international clinical trial guidance.
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