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News|Articles|July 16, 2026

Study Quantifies Financial Return of Risk-Based Quality Management in Oncology Trials

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Key Takeaways

  • Real-world RBQM performance data from 18 oncology trials were combined with Tufts CSDD oncology benchmarks to quantify trial- and program-level financial impact aligned with ICH E6(R3).
  • Phase duration reductions of 8%–19% generated estimated trial-level returns of $3.2M (Phase I) to $18.9M (Phase III), corresponding to 6x–23x ROI multiples.
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New peer-reviewed research combining real-world RBQM data with Tufts CSDD benchmarks finds ROI multiples as high as 23x, with time savings identified as the primary driver of financial value.

"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.”

A peer-reviewed study co-authored by researchers from CluePoints and the Tufts Center for the Study of Drug Development (Tufts CSDD) has produced quantitative evidence on the financial value of risk-based quality management in clinical development.1

The paper, published in Therapeutic Innovation & Regulatory Science, addresses a long-standing gap: while risk-based quality management (RBQM) has gained increasing acceptance as an operational framework aligned with ICH E6(R3), quantitative evidence on its financial impact has been limited.

The analysis combined real-world RBQM data from 18 oncology trials conducted on the CluePoints platform with published and proprietary oncology benchmarks maintained by Tufts CSDD.

Two primary financial measures were modeled: clinical trial-level ROI based on direct financial returns from monitoring-cost efficiencies and shorter trial durations, and development-program-level ROI based on risk-adjusted financial value across the broader oncology development pathway.

Key findings

RBQM-enabled trials were associated with 8% to 19% reductions in clinical phase durations. At the clinical trial level, estimated financial returns ranged from $3.2 million in Phase I to $18.9 million in Phase III, corresponding to ROI multiples of 6x to 23x. At the development-program level, expected net present value gains ranged from $3.8 million in Phase I to $13.8 million in Phase III, corresponding to ROI multiples of 4x to 14x.

The largest contributor to financial value was time savings, reinforcing that the strategic value of proactive, data-driven oversight extends beyond monitoring-cost reduction alone.

"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," said Kenneth McFarlane, VP of strategic consulting, and Sylviane de Viron, PhD, data and knowledge manager, both of CluePoints, in a press release. "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."

Abigail Dirks, senior data scientist at Tufts CSDD and primary author of the manuscript, noted that while the quality and oversight rationale for RBQM has long been recognized, adoption decisions also depend on whether organizations can quantify operational and financial value.

"This study provides an empirical evidence-based approach to estimating that value," she said in the press release, adding that broader benefits such as reduced rework, improved data integrity, inspection readiness, and organizational learning were not included in the models and could result in additional net financial returns.

Earlier coverage in Applied Clinical Trials

Earlier in June, Tufts CSDD submitted an article to ACT on the study findings, authored by Dirks and Ken Getz, MBA, executive director and research professor, also of Tufts CSDD. The piece provided additional methodological detail on how the financial assessments were structured and what they did and did not capture.2

The authors noted that a 2025 survey of 41 sponsor companies found that 42% reported seeing a positive ROI from RBQM, while 58% indicated it was too early to tell—underscoring the need for the kind of quantitative evidence the study provides.

They also emphasized that the benchmarks used reflect large pharmaceutical company oncology development experience, and that parameters such as cost of capital and operating costs will vary by company size.

The article also highlighted that certain deployment costs were excluded from the financial models, including those associated with first-time RBQM implementations such as training, SOP updates, change management, and data integration—factors organizations should account for when applying the methodology to their own portfolios.

References

1. CluePoints and Tufts CSDD Publish Peer-Reviewed Evidence Quantifying the Financial Value of RBQM. News release. CluePoints. July 7, 2026. Accessed July 16, 2026. https://cluepoints.com/cluepoints-and-tufts-csdd-publish-peer-reviewed-evidence-quantifying-the-financial-value-of-rbqm/

2. Quantifying the Net Financial Value of Deploying Risk-Based Quality Management. Applied Clinical Trials. Ken Getz, MBA, Abigail Dirks, MS. June 11, 2026. Accessed July 16, 2026. https://www.appliedclinicaltrialsonline.com/view/quantifying-net-financial-value-deploying-risk-based-quality-management

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