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Cyntegrity’s RBM ROI Calculator

Our RBM ROI calculator is not directional, and clinical experts shouldn’t live and die by its estimations. The calculator relies on a number of relatively simple inputs. Without having your actual data, the calculator provides a range (best to worst case) of improvement and return on investment (ROI) that’s possible deploying an RBM solution.

Nonetheless, the calculation formulas we’ve developed are based on observations, assumptions and data retrieved from independent publications and are demonstrably similar to what we’ve done for our clients. In fact, if you put your information in and find something that’s useful to you and your team, take the next step and reach out to us for a demo.

What Will Have the Greatest Effect on Reducing Risk?

Patient Enrollment

An article published in 2015 by Ken Getz, Associate Professor at the Tufts University, and a director at the Tufts Center for the study of Drug Development, shows the statistics of average delays (per indications) in patient recruitment for clinical trials. Although not surprising, the results indicate a big difference between the planned period for recruitment and its actual length. Those delays, which in average are doubling the recruitment period, create a negative financial impact on the overall cost of the study.

“Actual enrollment timelines typically double planned timelines.” (Tufts article)

Costly Monitoring

Clinical trial monitoring ranks as one of the most important, and expensive, aspects of running safe and effective studies that not only maintain patient safety, but also gain regulatory agency trust in data quality. Through the use of new and existing technologies, Risk-based Monitoring (RBM) allocates resources across studies based on their level of risk while maintaining patient safety and data quality. Risk-based Monitoring can deliver a bonus benefit: a potential
15–20% trial cost savings:

“Initial estimates show potential of Risk-based Monitoring to save 15 to 20% in study portfolio costs.” (PWC report)

Reduced Monitoring

Reduced monitoring is the process of monitoring less than 100% SDV, depending on protocol or site risk. A clinical study program that would traditionally require 100% SDV in the current model could see a reduction to 65% SDV as a result of a site’s risk. A program that would require 80% SDV in the current model could see 45% SDV in the risk-based model. Accurate evaluation of site risk allows these reduced SDV percentages to increase data integrity while reducing cost.

“A program that would require 80% SDV in the current model could see 45% SDV in the risk-based model.” (PWC report)

Lengthy Approval Timelines

The FDA is constantly looking to maintain the right balance of thoroughness and timelines when it comes to approving a new drug application (NDA) or biologic license application (BLA). A certain level of evidence regarding the efficacy and safety for a NDA or BLA is required before they can be approved and become available on the market. However, if the requirements are too burdensome, it can delay approval, and patients who could benefit will not be able to get the drug.

Despite the FDA’s Accelerated Approval Program, Tufts reports an average of 16 months for NDA/BLA Submission ─ Approval.

Potential Cost Savings

The ISR RBM market assessment report (November 2015) observes a 13.7% average cost decrease. The majority of clinical experts surveyed (56%) noted a cost decrease utilizing RBM in trials. Cost/time savings, resource utilization efficiencies and improved data quality drove the surveyed firms to embrace RBM.

“Monitoring cost reductions and data access and quality benefits drive RBM momentum gains.” (ISR report)

Literature References:
  • Tufts, The Cost of Clinical Trial Delays – Jan 2015
  • PWC, Risk-based monitoring: Reduce clinical trial costs while protecting safety and quality – Mar 2013
  • Tufts, CSDD briefing on R&D cost study – Nov 2014
  • ISR, Risk-Based Monitoring Market Assessment Report – Nov 2015