RBQM Track Welcome! - FDAnews · MCC Ambassador. Director, DMPI & DIGR-ACT. [email protected]. CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4 -5, 2019

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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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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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


Polling Question 1How do you rate your level of experience with Risk-Based Quality Management (RBQM)? A. NoviceB. IntermediateC. Expert

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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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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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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


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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Polling Question 4 – 2018 SummitWhat do you find is the best starting point for identifying high priority risks?

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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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Polling Question 6Enter one word (maximum of three) to describe the most significant challenge in implementing RBQM

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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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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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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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One Year Of…

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MCC Centralized Monitoring WG

KRI & Data Monitoring

MCC Study Quality Trailblazers

Risk Assessment & Mitigation

Best Practice Communities


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


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


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”


“important”

Action effective



“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!


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]

Documents

RBQM Track Welcome! - FDAnews · MCC Ambassador. Director, DMPI & DIGR-ACT. [email protected]. CLINICAL TRIAL RISK AND PERFORMANCE MANAGEMENT SUMMIT SEPTEMBER 4 -5, 2019