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An R-Based Landscape Validation of a Competing Risk Model
Published on: September 16, 2022
Quantifying the Financial Return on Investment of Risk-Based Quality Management Implementation in Clinical
Abigail Dirks1, Sylviane de Viron2, Kenneth McFarlane3
1Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, MA, USA. Abigail.Dirks@tufts.edu.
Therapeutic Innovation & Regulatory Science
|June 25, 2026
Summary
Risk-based quality management (RBQM) adoption is boosted by demonstrated ROI. RBQM improves clinical trial efficiency, reducing phase durations and costs, leading to significant financial returns.
Area of Science:
- Clinical trial management
- Pharmaceutical development
- Quality management systems
Background:
- Limited adoption of risk-based quality management (RBQM) principles in drug development due to a lack of quantitative return on investment (ROI) evidence.
- Stakeholders require data-driven justification for implementing RBQM.
Purpose of the Study:
- To estimate the return on investment (ROI) of risk-based quality management (RBQM) at both clinical trial and program levels.
- To provide quantitative evidence supporting the business case for RBQM adoption in drug development.
Main Methods:
- Two assessments were conducted: clinical trial level ROI analysis (monitoring cost efficiencies, phase duration reductions with 10% source data verification) and program-level ROI using expected net present value (eNPV) modeling.
- Analyses utilized data from 18 completed oncology trials employing RBQM, alongside industry benchmarks.
Main Results:
- RBQM implementation led to 8-19% reductions in clinical phase durations and up to 18% in monitoring costs (10% SDV scenario).
- Clinical trial ROIs ranged from $3.2M (Phase 1) to $18.9M (Phase 3), with multiples of 6x to 23x.
- Program-level eNPV gains ranged from $3.8M (Phase 1) to $13.8M (Phase 3), with multiples of 4x to 14x.
Conclusions:
- Demonstrated ROI at trial and program levels provides a strong business case for RBQM adoption, aligning with ICH E6 R3 guidelines.
- RBQM enhances data quality, risk detection, resource allocation, development efficiency, and portfolio productivity.
- RBQM represents a strategic investment for optimizing drug development processes.
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