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Unlocking Value in Risk-Based Monitoring: A Strategic Approach

Discover how a strategic approach to risk-based monitoring (RBM) can help companies overcome challenges and maximize the value of RBM implementation. Learn about key elements such as risk assessment, Key Risk Indicators (KRIs), ongoing monitoring, and outcomes execution planning. Gain insights into the benefits of RBM and how it can optimize trial-level quality and integrity. Explore the strategic and tactical views of RBM, as well as analytics-powered approaches. Find out how RBM generates value by minimizing wasted effort and optimizing investments. This article also highlights the importance of clarifying what RBM is and how to implement it effectively. Take a closer look at the various clinical trial processes and data involved in RBM and understand the complexity and cost associated with implementing a complete RBM capability. Discover targeted entry points such as targeted Source Data Verification (SDV), risk planning and issues management, and central monitoring. Learn how to achieve RBM value with the right approach.

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Unlocking Value in Risk-Based Monitoring: A Strategic Approach

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  1. RBM: Getting Beyond the Promise and Getting To Value SCOPE Conference, February 2019 Gary Thompson, VP Strategic Consulting, Medidata Solutions

  2. RBM: Lots of Promise… Where’s the Value? May 2013: Current model for RBM laid out in TransCelerate whitepaper Nov 2016: Reinforced and formalized in regulations with release of ICH E6:R2 July 2018: 32% of industry respondents have yet to develop an approach to KRIs* Nov 2018: FDA concerns with slow industry adoption of risk-based approaches and realizing speed and cost benefits** * “Risk-based Monitoring: Widespread Implementation is Underway, but Still Messy”, CenterWatch Weekly, July 9, 2018 ** “Harnessing Real World Evidence for Safety and Innovation”, Scott Gottlieb, M.D., Commissioner of Food and Drugs, Remarks to Reagan-Udall Foundation, November 19, 2018

  3. Why Haven’t Companies Seen Enough Value to Pursue RBM More Aggressively? Companies miss value in RBM for one of three reasons Challenges with the discipline, time and resources required to implement and execute RBM at scale Confusionabout what RBM is and how they should be implementing it Uncertaintyover what their RBM value proposition is

  4. Clarifying RBM: What It Is Iteration Risk Assessment KRIs QTLs Ongoing Monitoring Quality Report Statistical/Analytical Approaches Outcomes Execution Planning Central Monitoring How Remote Monitoring Where Risk-based Monitoring Why ICH E6:R2 Trial-Level Quality/Integrity Trial-Level Quality/Integrity Strategic KRIs Risk Assessment AI/ML Data Point-Level Quality/Integrity Tactical Data-Point -Level Quality/Integrity Analytics-Powered Approaches Traditional Approaches

  5. Clarifying RBM: How It Works Trial-Level Quality/Integrity Trial-Level Quality/Integrity Strategic View Risk Assessment KRIs AI/ML Data Point-Level Quality/Integrity Tactical View Data Point-Level Quality/Integrity Risk-Based and Analytics-Powered Approaches Traditional Approaches Trial-Level Quality/Integrity Trial-Level Quality/Integrity Trial-Level Quality/Integrity Trial-Level Quality/Integrity Trial-Level Quality/Integrity Trial-Level Quality/Integrity Trial-Level Quality/Integrity Trial-Level Quality/Integrity Strategic Trial-Level Quality/Integrity Trial-Level Quality/Integrity Strategic Trial-Level Quality/Integrity Strategic Trial-Level Quality/Integrity Strategic Strategic KRIs Risk Assessment Strategic KRIs Risk Assessment KRIs Risk Assessment KRIs Risk Assessment KRIs Risk Assessment KRIs Risk Assessment AI/ML AI/ML AI/ML AI/ML AI/ML AI/ML Data Point-Level Quality/Integrity Data Point-Level Quality/Integrity Data Point-Level Quality/Integrity Tactical Data Point-Level Quality/Integrity Tactical Data Point-Level Quality/Integrity Tactical Data-Point -Level Quality/Integrity Data Point-Level Quality/Integrity Tactical Data-Point -Level Quality/Integrity Tactical Data-Point -Level Quality/Integrity Tactical Data-Point -Level Quality/Integrity Data-Point -Level Quality/Integrity Data-Point -Level Quality/Integrity Analytics-Powered Approaches Traditional Approaches Analytics-Powered Approaches Traditional Approaches Analytics-Powered Approaches Traditional Approaches Analytics-Powered Approaches Traditional Approaches Analytics-Powered Approaches Traditional Approaches Analytics-Powered Approaches Traditional Approaches

  6. How RBM Generates Value “Perfect” Wasted Effort Target (KRI) QTL Valuable Effort Quality (eg., protocol compliance, data quality, etc) ∞ Cost (eg., financial, human resources, time, delays to patients)

  7. How RBM Generates Value “Perfect” Wasted Effort • Company A(overinvestment in quality activities) • Consistently meeting safety, quality, and compliance demands, but with excessive burden and time • Opportunity to decrease costs while maintaining high quality Target Investment exceeds risk = Wasted efforts QTL Risk exceeds investment = Quality gap Valuable Effort Optimal risk-based quality investment Quality • Company B(underinvestment in quality activities) • Concerned about / unsure of consistent quality and compliance delivery, but challenged to make sharply higher investments • Opportunity to increase quality with minimum, targeted additional investment (eg., protocol compliance, data quality, etc) Relative Risk (Criticality and Frequency) ∞ Cost (eg., financial, human resources, time, delays to patients) Various Clinical Trial Processes / Data

  8. A Complete RBM Capability is Worth it… and also Complex, Expensive, Demanding Entry Point – Targeted SDV: Reduce site monitoring costs Iteration Targeted SDV Issues Management Integrated Workflow Risk Assessment KRIs QTLs Ongoing Monitoring Quality Report Statistical/Analytical Approaches Industry: TBD RACT Central Monitoring AI / ML Outcomes Execution Planning Entry Point - Risk Planning and Issues Management: Improve Control of the Quality Process Entry Point – Central Monitoring: Augment quality assurance through analytics ICH E6:R2 Solutions

  9. RBM Value: Achievable with the Right Approach Getting to RBM Value requires clear, smart decisions Get clear on the components of RBM and what’s needed for your goals Be smart about which of the RBM value propositions is right for your company Be decisive on your best path: All-in or start with a specific entry point

  10. Thank you. gthompson@medidata.com

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