A peer-reviewed study published in Therapeutic Innovation & Regulatory Science has provided new evidence suggesting that risk-based quality management (RBQM) can reduce clinical trial timelines while delivering substantial financial returns across oncology drug development programmes.

The research was conducted by investigators from CluePoints and the Tufts Center for the Study of Drug Development (CSDD) and analysed data from 18 oncology clinical trials using RBQM alongside industry benchmarking data.

According to the analysis, implementation of RBQM was associated with reductions in clinical trial durations ranging from 8% to 19% across development phases.

The researchers estimated that individual clinical trials could generate financial returns ranging from approximately $3.2 million in Phase 1 studies to $18.9 million in Phase 3 studies, equivalent to estimated returns on investment of between six and 23 times implementation costs.

At the wider drug development programme level, the study estimated improvements in expected net present value ranging from $3.8 million to $13.8 million, with corresponding returns on investment of between four and 14 times.

The authors concluded that shorter development timelines contributed more to financial value than reductions in monitoring costs, highlighting the importance of proactive quality oversight throughout clinical development.

Kenneth McFarlane, vice president of strategic consulting at CluePoints, said: “What is powerful about this study is that it translates RBQM impact into the language of clinical development decision-making: time, cost, ROI and portfolio value.”

The researchers noted that the analysis focused primarily on measurable operational and financial outcomes. Potential benefits including improved data integrity, reduced rework, inspection readiness and training efficiencies were not included in the economic model.

Risk-based quality management has become increasingly established within clinical development following updates to international good clinical practice guidance, including ICH E6(R3), but evidence quantifying its financial impact has remained limited.

The authors said the methodology could be adapted by pharmaceutical companies to assess the potential value of RBQM within their own clinical development portfolios.