rbqm track welcome! - fdanews · mcc ambassador. director, dmpi & digr-act....
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019PHILADELPHIA, PA USA
RBQM Track
Welcome!
Keith DorricottMCC AmbassadorDirector, DMPI & [email protected]
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Intro VideoPlay “MCC Summit RBQM Track Welcome 4Sep2019”
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
What is Risk Based Monitoring (RBM)?• Means different things to different people!• Historically, focus was site monitoring (“little m”)• ICH E6 (R2) uses “Monitoring” to mean both site monitoring and
monitoring of trial risks (“big M”)• Proposal at FDA Summit to use term “Risk-Based Quality
Management (RBQM)” rather than “Risk-Based Monitoring”• Centralized Monitoring is one tool of RBQM
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
What is RBQM?
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5.0.1 Critical Process &Data Identification
5.0.2 Risk Identification
5.0.3 Risk Evaluation
5.0.4 Risk Control
5.18.3 Extent & Nature of Monitoring
5.0.5 Risk Communication
5.0.6 Risk Review
5.0.7 Risk Reporting
5.20.1 Noncompliance
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 1How do you rate your level of experience with Risk-Based Quality Management (RBQM)? A. NoviceB. IntermediateC. Expert
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 2Does your organization conduct formal assessments of project/protocol-level risk prior to study conduct?A. Yes (all studies)B. Yes (most studies)C. Yes (pilot basis)D. Planning to begin in next 12 monthsE. NoF. Not applicable
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 3Does your organization conduct formal assessments of project/protocol-level risk during study conduct?A. Yes (all studies)B. Yes (most studies)C. Yes (pilot basis)D. Planning to begin in next 12 monthsE. NoF. Not applicable
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 2&3 – 2018 SurveyDoes your organization conduct formal assessments of project/protocol-level risk prior to / during study conduct?
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63%
71%
21%
19%
16%
10%
During Study Conduct
Prior to Study Conduct
Yes Plan to in next 12 months NoN=58
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 4What do you find is the best starting point for identifying high priority risks? A. Risks/issues from previous trialsB. Critical data & critical processesC. Pre-existing list of potential risks (e.g. RAMMT)D. Not Sure
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 4 – 2018 SummitWhat do you find is the best starting point for identifying high priority risks?
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 5What level of impact has RBQM had on your organization’s site monitoring practices? A. SignificantB. Some changeC. Minimal changeD. NoneE. Not applicable
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Polling Question 6Enter one word (maximum of three) to describe the most significant challenge in implementing RBQM
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
RBQM Track Agenda – Day 11:30pm Panel – Risk Management Emerging Practices2:30pm Presentation – Normalization of KRIs and QTLs3:00pm Break3:30pm Panel – Risk-Based Site Monitoring Emerging Practices4:15pm Breakout Groups5:30pm Close
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Day 2 MCC Demos 7:30am RBQM
oCost of Poor Quality TooloProtocol Operational Complexity Scoring TooloRisk Assessment & Mitigation Management Tool 2.0oCentralized Monitoring Guidance Document
Vendor OversightoRelationship MetricsoQuality Metrics
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
RBQM Track Agenda – Day 27:30am MCC Demos
8:30am Open8:50am Presentation – RBQM / CM: What skills are needed?9:30am Panel – The future of RBQM10:30am Break11:00 Breakout Groups12:00 Lunch
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CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
One Year Of…
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MCC Centralized Monitoring WG
KRI & Data Monitoring
MCC Study Quality Trailblazers
Risk Assessment & Mitigation
Best Practice Communities
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
One Year Of…
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MCC Centralized Monitoring WG
KRI & Data Monitoring
• Role of CM in oversight• QTLs• FDA Draft Guidance Q&A• Comparison – CM and DM• Skills of the Central Monitor• CM with eCOA and ePRO data
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
One Year Of…
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MCC Study Quality Trailblazers
Risk Assessment & Mitigation
• Implementation of MCC Risk Assessment and Mitigation Management Tool 2.0
• When to use: Protocol Operational Complexity Scoring Tool and RAMMT
• FDA Draft Guidance Q&A• Next: ICH E8 (R1), Risk Libraries,
RAMMT 3.0, POC Scoring Tool review
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
Quality Tolerance Limits
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Week 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20# subjects 0 0 1 2 7 18 47 119 219 420 550 660 750 850 900 950 970 1000 1000 1000# not meeting perprotocol 0 0 0 0 0 0 0 1 2 4 7 11 17 17 17 17 17 17 17 17Parameter (% Not Meeting Perprotocol) 0.0% 0.0% 0.0% 0.0% 0.0% 0.8% 0.9% 1.0% 1.3% 1.7% 2.3% 2.0% 1.9% 1.8% 1.8% 1.7% 1.7% 1.7%
QTL breach – must be reported in CSR if deemed
“important”
QTL breach – must be reported in CSR if deemed
“important”
Action effective
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
QTL breach – must be reported in CSR if deemed
“important”
Action effective
Quality Tolerance Limits
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We are developing an addendum to the MCC Centralized Monitoring Guidance Document on
this and other topics.
Interested in being involved? Reviewing?Let me know!
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4-5, 2019 PHILADELPHIA, PA USA
New Metric Development Work Group• CM Work Group continues best practice focus• New Centralized and Site Monitoring Metrics WG will meet from
Oct 17th
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• RBQM has added complexity:oHow do you know if the new process is working
as it should?oAre you measuring the right things to oversee
and manage the process?oWhat are your peers measuring?
Study Manager
CTMS
Functional Leads
SystemsEDC Safety
Regular Site & CRAVisits
Traditional Approach
Regular
KRIs, SDM, Trending
Study Data
Central Monitor
Risk Review
CTMS
Functional Leads
Study Manager
Systems
Site & CRA
EDC Safety
VisitsTriggeredRemote
Visits
With RBQM
CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT
SEPTEMBER 4-5, 2019PHILADELPHIA, PA USA
RBQM Track
Welcome!
Keith DorricottMCC AmbassadorDirector, DMPI & [email protected]