innovated supply chain management: efficiencies and cost reduction in clinical trials
TRANSCRIPT
Innovative Supply Chain Management
Efficiencies and Cost Reduction in Clinical Trials
Chris WilkeChief Technology Officer
DATATRAK
23rd AnnualEuroMeeting
28-30 March 2011Geneva, Switzerland
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Disclaimer
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Agenda
Review typical challenges
Investigate an innovative approach
Discuss case studies
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Rewarding + Invigorating + Satisfying
Life Sciences Product Development
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Challenging + Costly
Life Sciences Product Development
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Our Challenge
Efficiency
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Cost
Laden with Integrated Silos
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Redundant Processes
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Lost Time
Inhibit Decisions
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Separate Data
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Separate Data Challenges
Poor visibility
Elongated timelines
Lack of accountability
Data invisible until process end
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Is there a better way?
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Yes. We can leverage our EDC investment.
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EDC can unlock this…
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Unified Data
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Benefits
Data are visible during trial
Direct export to analysis set
Visibility of data management
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IBM wrote a paper on it.
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The FDA has draft guidance on it.
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Case Study 1
Phase III Double-Blind Dose-Escalation
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Dose Escalation Challenges
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4 different drugs
Complex escalation criteria for each drug
Kit-based supply
Unevenly scheduled visits (16 kit types)
Investigator decision
Which 16 kits do we ship?
How many of each kit?
And when?
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Optimal Supply Chain Factors
Cost of drug
Cost of shipment
Availability of drug to ship
Regional depots
Shipment timing
Expiration dates
Estimated site enrolment
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Data Required to OptimizeEDC
Patient demographics
Patient visit vitals
Central Lab
Key lab values
Randomization
Treatment assignment
Drug Supply
Drug inventory
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Optimized SolutionDelay shipments based on visit schedule
Delay shipments based on escalation
Shipment size based on site enrolment
Escalation options restricted to protocol
Combine shipments to reduce costs
All events triggered by eCRF input
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Case Study 2
Phase II Double-Blind
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Challenges
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4-year study
Controlled substance drug
Cost to ship was very high
Multiple dose levels
Initial supply lasts 120 days
Data Required to OptimizeEDC
Number of active patients
Patient demographics
Randomization
Multiple patient doses
Patient dose level
EDC Visit Schedule
Number of visits in next 120 days
Drug Supply
Site inventory levels
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Optimized SolutionSystem performs 120-day Inventory
Evaluation– Number of enrolled patients– Multiple patient doses– Number of visits in the next 120
days– Site inventory levels
System determines how many additional vials are required for each site over the next 120-day period
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SummaryTraditional data collection works
Unified data is a growing trend
Unified data unlocks optimization
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