risk-based monitoring: seeing the forest for the trees ... · confidential – for internal use...
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Confidential – For Internal Use Only
RISK-BASED MONITORING: SEEING THE FOREST FOR THE TREES WHEN DESIGNING AND IMPLEMENTING AN ENTERPRISE PROCESS
Ben Dudley, Executive Director Alliance Management, Covance Inc.
DIA 50th Annual MeetingSan Diego CA, 17 June 2014
Confidential – For Internal Use Only
Topics Covered
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Starting with the end in mind• Process• Technology
Why embark on an RBM journey?
Implementation examples & learnings
Value – what is the ‘return on RBM’?
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Today’s Biggest RBM Risk
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Key success factor: differentiating between enablers, elements and outputs – and solutions and objectives
I Know There is a Forest In There Somewhere…
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WHY EMBARK ON AN RBM JOURNEY?
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RBM: Coming to a Trial Near You – and Soon…
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RBM will become the new normalSource: Industry interviews commissioned by Covance. * Note: Not a quantitative forecast
Current use of RBM solutions
Expected use of RBM solution in
the next 10 years*
Expected use of RBM solution in the next 5 years*
Traditional Monitoring ApproachesRBM
Increased quality
expectations
Development cost
increasesRBM process
maturationRegulatory mandate
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Covance Definition of RBM
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ID Critical Data/
Processes
ID Critical Data/
Processes
Risk Identification
Risk Identification
Primary Prevention
Primary Prevention
Active Mitigation
Active Mitigation
Quality Surveillance
Quality Surveillance
Identification and Repair
Identification and Repair
AdaptationAdaptation
RBM is a logical next step to enhance efficiency and quality
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• Holistically identifies risk of failure
• Designs monitoring approaches to prevent or mitigate risk
• Differentiates critical vs. non-critical
• Delivers fit for purpose quality –flexible to study and regulatory need
• End to end trial conduct transformation
• An extension to smart study design
Confidential – For Internal Use Only
Covance RBM: Transformation – and Continuity
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Prediction
Primary Prevention
ProactiveDetection
Secondary Prevention and Repair Patient Safety
Data Integrity
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FDA Final Guidance on RBM
EMA Draft Reflections Paper and FDA Draft Guidance on RBM
TransCelerate Updated Paper on RBM
Predictive, proactive and preventative
operational platform established
Various academic research model studiese.g. more than 8,000 patientstargeted monitoring
More than 8,000 patients cardiovascular trialReduced source data verification analytics: data action reports targeted & reduced monitoring
Strategic partner portfolio ‘Fit-for-purpose’ monitoring tailored monitoring & SDV in multiple therapy areas and studies
More than 12,000 patientsFull RBM implementation incl. tSDV web-based analytics solution
New clinical quality control process
2012 20142011201020092005
New site quality risk reports
Expanded informatics capability
2013
Launch of Covance RBM dashboard and process
The Journey to Develop RMB Core Expertise and Systems
Confidential – For Internal Use Only
Governance: Defining the Team to Get Us There
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Core DevelopmentTeam
Process & Documents
Organization Design
Functional Teams
CommercialIT & Technical Requirements
Business-Led Transformation Team
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PROCESS: TYING IT ALL TOGETHEROR -STARTING WITH THE END IN MIND
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Start with the End in Mind
Design & Delivery: Fit for purpose throughout the continuum
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Clinical Operations
RegulatoryMedical & Statisticsl
Data Management
Data Management
Medical
ProtocolDesign
CRFDesign Monitoring Data
CleaningMedical & Statistical
ReviewNDA/MAA
Submission
Confidential – For Internal Use Only
RBM – If You Start with Monitoring it’s Too Late
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Starts with designing out risk: the protocol is the blueprint for qualityStart with the end in mind: reliable data withstanding Agency scrutiny
Feedback throughout study
ProtocolDesign
1Risk
Assessment
2Monitoring
Plan
3Performance
Analytics
4 Monitoring Interventions
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Issue Resolution
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Translating Risk into Action
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Appropriate risk management: Not ‘one size fits all’
Examples Management ApproachesIntrinsic
Risks• Maturity of safety profile• Phase of development
• Average on-site visit interval• Source Data Verification level• Proportion remote/on site visits
Design Risks
• Clarity of protocol• Primary endpoint approach• Fit vs. standard of care
• Quality by design improvements• Central data surveillance• Supplementary training (Site & CRA)
In-Flight Risks
• Site experience• Protocol deviation rate• Investigator oversight
• Adjusted site-specific intervention levels• Turnover management & training plans• Issue management plans
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Full Portfolio of Actionable Tools
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Site Risk Dashboards
RBM Templates
ProcessIntegrations
Functional Process Tools
Web-Based Visualizations
ControlCharts
Training Materials
Clinical Data Repository
RBMTeams
Implementation-Ready, Tried and Tested
Process Manuals
RiskLibraries
Risk Assessment
Tools
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TECHNOLOGY:A KEY ENABLER
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Effective RBM is Multifaceted –Technology is Not the Be All And End All
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Risk Assessment
Technology Platform
Adaptation & Control
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IMPLEMENTATION:EXAMPLES & LEARNINGS
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Overcoming Functional Barriers
Focused change management
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• “RBM is all about clinical cost reduction”
• “Quality will suffer on variables not monitored” – risk prevention not considered
• “There is nothing wrong with how we’ve done things before”
• ‘Burning platform’ challenge is only for Clinical Operations
Functional View
• Quality of critical data & processes enhanced through preferential focus
• Cost saving is a consequence of monitoring what matters
• Focus on Quality by Design and Risk, not SDV reduction
• Areas reduced are not critical from an outcome perspective
Holistic View
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• Cardiovascular outcomes study• Full RBM Design• tSDV implemented• Ongoing, enrolling
Example #1
Experiences from Implementation
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• Partner portfolio• ‘Fit-for-purpose’ monitoring• Tailored RMV/SDV• Multiple studies and TAs
Example #3
• Phase III Pivotal Study• Reduced SDV• Targeted RMV strategy• NDA/MAA approved
Example #2
Confidential – For Internal Use Only
Implementation Learnings
2020
• Variable needs and priorities• Tailored solution needed, consistent but flexible
Sponsor
• Managing monitor support expectations• Expectation-setting and alternative methodologies
Site
• Resource management• Change management• Access to information
Monitors
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VALUE:WHAT IS THE ‘RETURN ON RBM’?
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RBM Value, It’s All In The Design
• Protocol simplification• Quality-by-design• Risk-based site selection• Systematic mitigation• Centralized data surveillance• Risk-targeted on-site review
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EFF I C I ENCY
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QUA L I T Y
Quality and Efficiency go Hand-in-Hand
Confidential – For Internal Use Only23
RBM can transform risks into returns• Effective, adaptive resources allocated targeting maximum impact and value• Proactive planning and focus on primary quality and state of control• Efficiency gains a consequence of fitness-for-purpose
Mutually Beneficial Implementation
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• Fit for purpose quality
• Alignment with regulators
• Demonstrated state of control
• Timely delivery
• Improved efficiency
SPONSOR PRIORITIES
COVANCEPRIORITIES
Confidential – For Internal Use Only
For more information please visitwww.covance.com/RBM
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