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Michelin Star in endpoint adjudication…are we there yet?
Maria Ali Global Head, Medical and Safety Services and Scientific Leadership (Olivia Szeto, Andrea Yong)
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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Sources of Event Identification
Report Design Study Set-up Edit checks in eCRF Voting Form Design
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Minimising Unreported Endpoints
EAC Training Sources of Event Identification Relationship between Endpoint and PV Teams Utilise Medical Monitors and EAC Even in studies where we’ve seen with sophisticated trigger systems with automated sweeps of the SAE there are still a number of events being identified by MM narrative review or EAC members.
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Sources of Event Identification
Relationship between Endpoint and PV Teams EAC Training Utilise Medical Monitors and EAC
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Edit checks in eCRF Minimising Unreported Endpoints
System Error Generation Checks “Potential Endpoint Flags” Automate EAC or Medical Monitor Identified Events Automatic Generation of Endpoint Pages Automatic generation ensures that events are not reliant on sites to enter. Decreases the likelihood of missing events We are used to placing flags on obvious events such as MI. But we should explore broader flags such as con meds such as diuretics being an indicator of heart failure, or electrolyte changes for potential renal events.
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Edit checks in eCRF Minimising Unreported Endpoints
Automate EAC or Medical Monitor Identified Events Automatic Generation of Endpoint Pages System Error Generation Checks “Potential Endpoint Flags” Minimising Unreported Endpoints
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Voting Form Design Edit Checks in Adjudication Platform
Form Intricacies leading to contradictory reviews Voting Form Design Form Logic Forms can be complex and by the time you’ve drilled down you can lose perspective. Dynamic forms have rigorous logic and only provide applicable sub-options e.g. dialysis form: endpoint yes but why was dialysis ceased: patient recovered.
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Voting Form Design Edit Checks in Adjudication Platform
Form Intricacies leading to Contradictory Reviews Form Logic
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Create reports that provide meaningful data for effective quality and process management
Report Design Click while speaking Looking at average times is insufficient must create meaningful reports that generate medians and IQR e.g.
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Report Design Create reports that provide meaningful data for effective quality and process management
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Sources of Event Identification
Report Design Study Set-up Sources of Event Identification Voting Form Design Edit checks in eCRF
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Sources of Event Identification
Study Set-up Sources of Event Identification Report Design Voting Form Design Edit checks in eCRF
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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Ongoing Study Maintenance
Workflow Development Modelling Projections Ongoing Study Maintenance Report Processing Review Comments
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Ongoing Study Maintenance
Workflow Development Ongoing Study Maintenance Report Processing Review Comments Modelling Projections
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Set up clear escalation timelines to ensure expedited clearance of events
Query reports generated regularly to filter and process answered queries Workflow Development Set up workflows that are designed to continuously sweep work Adjudication Workflow Generation of query Aging of the query Reports to review answered queries Escalations and the responsible parties (Stakeholder management) Escalations = implement automation to increase efficiency but must be balanced with effective stakeholder management. Regularly reported adjudication metrics to increase engagement
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Workflow Development Set up workflows that are designed to continuously sweep work Query reports generated regularly to filter and process answered queries Set up clear escalation timelines to ensure expedited clearance of events Adjudication Workflow Regularly reported adjudication metrics to increase engagement
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Adjudication Workflow
Enforce comments in voting forms Flag case complexities Compulsory review of comments during event closure Request panel review Highlight concerns regarding case trends Analysis of adjudication to highlight discrepancies in responses Comments and comment review: Highlight concerns regarding cases trends e.g. when something is unknown and it is unclear on how to interpret that data. E.g. use of F1 (safety follow-up) visit in confirming renal events Development of adjudication and disagreement metrics QC Rounds Prompt and responsive system to ID and mitigate discrepancies
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Adjudication Workflow
Compulsory review of comments during event closure Flag case complexities Request panel review Highlight concerns regarding case trends Enforce comments in voting forms Analysis of adjudication to highlight discrepancies in responses QC Rounds Development of adjudication and disagreement metrics Prompt and responsive system to ID and mitigate discrepancies Adjudication Workflow
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Regularly reported adjudication metrics
Enables informed data sweeps that can be adapted to suit study needs Regularly reported adjudication metrics Disagreement metrics – highlight needs for re-training
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Regularly reported adjudication metrics
Enables informed data sweeps that can be adapted to suit study needs
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Workflow Development Set up workflows that are designed to continuously sweep work Query reports generated regularly to filter and process answered queries Set up clear escalation timelines to ensure expedited clearance of events Adjudication Workflow Regularly reported adjudication metrics to increase engagement 100% data entry QC checks
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Workflow Development 100% data entry QC checks Set up workflows that are designed to continuously sweep work Query reports generated regularly to filter and process answered queries Set up clear escalation timelines to ensure expedited clearance of events Adjudication Workflow Regularly reported adjudication metrics to increase engagement
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Modelling Projections Modelling Projections
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Modelling Projections
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Ongoing Study Maintenance
Modelling Projections Workflow Development Ongoing Study Maintenance Report Processing Review Comments
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Ongoing Study Maintenance
Modelling Projections Workflow Development Ongoing Study Maintenance Report Processing Review Comments
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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Study Close Development of export outcome reports that capture the comments FDA may utilise reports to review information Prompt generation of outcome reports that capture entirety of adjudication forms Silent MI example (if time permits) Enables swift response of Sponsor to FDA enquiry
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Study Close Prompt generation of outcome reports that capture entirety of adjudication forms Enables swift response of Sponsor to FDA enquiry Development of export outcome reports that capture the comments FDA may utilise reports to review information
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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Ongoing Study Maintenance
Quality Checkpoints Study Set-up Ongoing Study Maintenance Study Close Quality Reviews Edit checks Quality checks across adjudication forms Stat checks Free text review Open and Answered queries Study set-up Edit checks in eCRF Voting form design Report design Ongoing study maintenance Workflow development Report processing Review comments Study Close Development of export outcome reports that capture the comments FDA utilitses these to capture information Audit Readiness
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