dia issue management ken wu final
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Controlling the Killer KRINew Solutions to Address Protocol Deviations
Kenneth Wu, MS, MBAClinical ConsultantKenneth Wu and Associates, LLC
@kennwu
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• The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated.
• These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, Drug Information Association Inc., DIA and DIA logo are registered trademarks. All other trademarks are the property of their respective owners.
Disclaimer
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I am a subject matter expert consultant to Comprehend Systems, a technology company with a class of cloud software to help Clinical Operations.
Financial Disclosure
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Persistent Key Risk Indicators (KRI) Over Time
Top 3 Critical Findings# 2000-2006 2007-2009 2010-2012
1 IMP Compliance
Patient Selection* Monitoring**
2 Clinical Study Report
Source Documentation
Patient Selection*
3 Safety Reporting* Monitoring** Efficacy
Assessment*
(Source: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/12/WC500178525.pdf)
*Protocol Compliance by Investigator**Trial Management by Sponsor
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Consistent KRIs by Inspectors
Top 3 483 Issued# 2010-2011 2012-2013 2014-2015
1 Protocol Compliance*
Protocol Compliance*
Protocol Compliance*
2 Source Documents*
Source Documents*
Source Documents*
3 IRB Meeting Minutes
Accountability Records
IRB Meeting Minutes
(Source: www:fda.gov/ICECI/Inspections/ucm250720.htm)
*Protocol Compliance and Source Documents by Investigator
Confidential and Proprietary: Not for Distribution
Investigators
Monitors
Safety Reps
Data Managers
Multiple CROs
Slow Investigation
Limited Visibility
Don’t Know Where to Focus
No Audit Trail
Act Slowly
Uninformed Decisions
Distributed ClinOps Teams
Biostaticians
Focus on Sites
SILOED OPAQUE DISTRACTED
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Issue management
Identify
Triage
Validate
CAPA
Implement Four-step Process
Analyze
Continuous Improvement
Clinical Intelligence
Regulatory Risk Operational Risk
Protocol Compliance Enrollment Site Management
Subject Visit FunnelProtocol Deviations
Adverse EventsPrimary Endpoint Data
Site ActivationEnrollment Funnel, based on
patient status:ConsentedScreened
RandomizedEnrolled
WithdrawnEvaluable
Monitoring VisitsData Entry
Query ResolutionIssue ResolutionDrug Inventory
Step 1: Identify KRIs
Step 2: Triage
Risk Type High Risk Low Risk
Operational Risk
Enrollment high screen failure high withdrawal
slow enrollment unknown barriers
Site Productivity non-performing sites high number of queries
low site performance aged queries
Regulatory Risk
Protocol Compliance protocol deviations unexpected events
low data quality missing data
Missed Milestones Milestone Achievement
FDA Action FDA Approval
Step 3: Analyze
Confidential and Proprietary: Not for Distribution
ClinOpsTeams
Fully Defend
See Everything
Focus on What Matters
ActivelyInvestigate
Act Faster
SitesInvestigators
Monitors
Safety RepsData Managers
Biostaticians
multipleCROs
Make Smarter Decisions
operational/clinical data
Step 4: Validation with Clinical Intelligence
Study Coordinators
Clinical Intelligence
Confidential and Proprietary: Not for Distribution
Use Case: Issue Management
1 Identify Real-time alert when deviations breach configured threshold
2 Triage Composite risk score provides a real-time comparison
3 Analyze One-click analysis: study, issue, and site levels
4 Validate Task management and follow up with audit trail
Protocol Compliance KRI
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Protocol Deviation: Alert and Triage
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3
4
2
Process Steps1. Protocol
Deviation
1. Risk Score 18
1. Medtrack Mount Center
1. CRA North America assigned
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Analyses: Study, Category, Trend
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1
3
Process Steps1. Beta 21
Study
1. Prohibited Concomitant Medication
1. June 2015 10 prohibited Concomitant Medications were reported
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Analyses: Outlier and Benchmark
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2
Process Steps1. Single outlier
on Prohibited Concomitant Medications
1. Canadian site was 1300% prohib. con. meds (1000x)
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Analyses: Granular Site Trend
Process Steps1. Prohibited
Con. Meds violations high %
1. Appears to be seasonal trend
1. Implement corrective actions
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2
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Validation: Audit trail, Continuous Monitoring
Process Steps1. Audit trail of
corrective action
1. Continuous monitoring
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© Comprehend 2015, Confidential & Proprietary | Page 18
Operational Risk
Regulatory Risk
High Low
High
Low
Value: Reduce operational and regulatory risks
ClinicalUncertainty
Reactive with high risk exposure
Clinical IntelligenceProactive with risk mitigation
Multiple benefits of this approach
Reduce cost of clinical operations
Minimize trial cycle time
Increase productivity
Mitigate Operational and
RegulatoryRisk
Proactively manage and resolve issues to keep trials on time
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Kenneth Wu, MS, MBAClinical ConsultantKenneth Wu and Associates, LLC@kennwuken@kenwullc.com
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