Statistic software provider CluePoints has announced the publication of new research investigating the financial value of risk-based quality management (RBQM) in clinical development.
The paper, co-authored by experts from CluePoints and researchers from the Tufts Center for the Study of Drug Development (CSDD), was published in the June edition of Therapeutic Innovation & Regulatory Science.
RBQM is a Quality-by-Design approach that uses prospective risk assessment, centralised/statistical data monitoring, key risk indicators, quality tolerance limits and targeted (rather than 100%) source data verification to shift routine site visits to continuous, remote, data-driven oversight.
Despite regulatory encouragement, RBQM adoption has been patchy — large pharma companies use it on around 63% of trials and smaller companies use it for around 48%.
Barriers to adoption include a lack of cross-functional buy-in, operational readiness and a lack of a proven financial case.
The study explicitly aimed to close this lack-of-quantifiable-ROI gap, which prior research has identified as the top blocker to adoption.
With ICH E6(R3) pushing risk-based approaches as the new GCP norm, the study's results could provide sponsors with a business case to justify switching to RBQM rather than relying on a regulatory nudge.
The analysis combined real-world RBQM data from 18 oncology trials conducted on the CluePoints platform with published/proprietary oncology benchmarks maintained by Tufts CSDD to model financial value across clinical development phases.
The analysis derived the following two primary financial measures:
- Clinical trial-level ROI based on the direct financial return from RBQM in individual trials due to monitoring-cost efficiencies and shorter trial durations
- Development-programme-level ROI based on the risk-adjusted financial value of RBQM across the broader oncology development pathway, accounting for costs, timelines, probability of success and discounted commercial performance.
Key findings included the following:
- RBQM-enabled trials were associated with 8%-19% reductions in clinical phase durations
- Monitoring costs were cut by up to 18% under a 10% source-data-verification scenario (versus a 100% SDV baseline)
- Trial-level ROI was $3.2m (Phase I) to $18.9m (Phase III)
- Programme-level (using expected net present value modelling) saw gains of $3.8m-$13.8m in value, corresponding to 4x-14x ROI multiples.
- Time savings, rather than monitoring cost savings, drove the bulk of the value, accounting for 75-97% of total eNPV gains across scenarios.
The authors did note, however, that results would likely vary by therapeutic area.
Kenneth McFarlane, VP Strategic Consulting and Dr Sylviane de Viron, Data & Knowledge Manager, CluePoints, said: “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."
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 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."
Abigail Dirks, Senior Data Scientist, Tufts CSDD and primary author of the TIRS manuscript, added: “The industry has long recognised the quality and oversight rationale for RBQM, but adoption decisions also rely on quantified operational and financial value."
This study provides an empirical, evidence-based approach to estimating that value. Importantly, the analysis modelled investment, operating impact and monitoring-cost and time-related savings.
"Other areas such as reduced rework, improved data integrity, inspection readiness and training costs were not included in the model. Applying this methodology to a company's own portfolio and experience can provide tailored insight into the value that RBQM can deliver."
