Signal Management with agSignals

Signal Management with agSignals
Dr. Yusuf Tanrikulu
[email protected]
Director, Signal Management
Merck Serono | Global Drug Safety
„Merck – Living Innovation“
ArisGlobal UGM, 11-Sep-2014
Introduction
 Web-based tool for signal management from ArisGlobal
 Customized towards Merck Serono‘s signal management process
 Workflow system to support timely signal management activities
 Ability to attach external files into the process
 Documentation of signals and traceability of annotations/comments/decisions
 Signal detection via scheduled reports
 Signal detection incorporated into workflow system
 Integration of ad hoc searches and analysis features
Signaling data, documentation and decisions made
are located in one place and are easily retrievable.
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Signal Management (SM) Process
Detection
Ongoing signal
detection activities
i.e. agSignals reports,
HA requests,
literature, …
 Product leads & therapeutic heads ongoingly
review any internal and external sources for new
potential associations of products and events.
Potential
association
Timing is driven by specifics of each drug
(maturity, # of cases, # of risks, AESIs)
Validation (Day 0)
Signal
 Findings are presented at management board and
either validated as a signal or not.
Evaluation (Day 0-70)
Signal
Evaluation
Report
 Signal evaluation reports are prepared in a
cross-functional team recommending an outcome.
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Identified Risk
Decision (Day 70-80)
Potential Risk
 CMO board finally decides on signal.
Signal Refuted
Signal Management with agSignals | Dr. Yusuf Tanrikulu
SM Process to agSignals Workflows (WF)
Detection
Process
 agSignals reports automatically appear in inbox
 Direct case annotations (stored in system)
 Case details and CIOMS I available
agSignals
Triage WF
- List of cases
Potential
association
- Statistical report
- Close monitoring
Validation
SM WF
 Signals are entered manually as SM workflows
and also appear in inbox until closure
Signal
VALIDATION
Validated/Not-Valid.
 Documentation of signal validation (minutes)
Evaluation
 SER is attached to signals
Signal
Evaluation
Report
EVALUATION
Recommendation
on signal
Decision
 Decision is documented in the system
(email or minutes)
Identified Risk
Potential Risk
Signal Refuted
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DECISION
Final status of
signal
Manually
created WFA
Application Structure
WORKFLOW
Inbox (tasks) | History List
QUERY: General or Statistical Analysis
Triage WF (30d)
automatically
Triage
Periodic
GA: List of cases
Dataset x

manually
Sig. Management WF (90d)
Validation

Evaluation

Decision

Ad hoc
GA or SA
External sources, e.g. HA requests
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Dataset
optionally
SA: Statistical reports
agSignals Signal Detection Reports
Time, e.g. one quarter of a year
Qualitative Review
Weekly listing of cases approved
Quantitative Review
Statistical reports using iPRR
on monthly basis
W1
W2
W3
Wx
…
Cases approved within last week
Frequency „in period“
Frequency of PT in „before period“
iPRR
Close Monitoring Events
CME reports listing cases
with AESIs only
Cumulative listing of AESIs
Can be grouped in custom
MedDRA query (CMQ)
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
Library of Products & CMQs
Product Groups
 Products can have multiple trade names
 For every product, a Product Group has to be defined
 Product Groups can only contain: Intl. trade name = Preferred Product Description (PPD)
 Example:
PG_CETUXIMAB
CETUXIMAB MERCK
ERBITUX
CMQs
 Besides SMQs, medical concepts may be defined by custom MedDRA queries (CMQs)
 CMQs can be used for close monitoring event reports
 Reports always use up-to-date CMQ from library
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
List of Cases
4 Complete activity
2
1 Annotate
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
3
Statistical Report
4 Complete Triage activity
3
2
1 Annotate
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
In-App Documentation
Comments
 Free text comments saved with
each accomplished step.
History list
 Signals and accomplished reports
are maintained in history list
 Comments, case annotations,
decisions can be easily retrieved by
time, product or event focus
External files
 Minutes, emails or PPTs can be
attached any time to signals and
reports
 Attachements are stored in the
database.
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
Training Plan
 Intense training needed
 Whole day training
 Hands-on exercises are essential
Introduction to agSignals
• Signal management process at Merck
• Signal management workflows in agSignals
• Periodic Reports
• Application structure
• Ad hoc analysis features
Q&A
Live Demo & Request Forms
Lunch Break
Exercise A1
Medical triage of list
of cases
Q&A
Exercise A2
Medical triage of
statistical report
Q&A
Exercise A3
Medical triage of
CME reports
Q&A
Break
Exercise B1
Sig. management
WFA for a
Validated Signal
Q&A
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agSignals Training | Dr. Yusuf Tanrikulu
Exercise B2
Ad hoc GA search
Q&A
Exercise B3
Generation of a
tabular summary of
signals (PBRER)
Q&A
User Support
 agSignals Forum
 Always on the same week day
 Always in the same room
 Always at the same time
 Parallel video confernce session for global users
 Users can stop by for feedback
 Ask any kind of questions
 Assistance in performing tasks
 [email protected]
 Main communication channel
 Remote control and telephone support
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
Summary
 Introduction of our signal management process
 Configuration in agSignals and benefits
 Standard agSignals reports for periodic medical review
 User training and support
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
End
Acknowledgements
Dr. Kristina Strutt (MS GDS)
Dr. Hans-Jörg Römming (MS GDS Systems)
Margot Stam Moraga (MS PO SM)
Sreeganesh Jaishankar (AG UK)
Manjunath Chekkadeviah (AG UK)
Dr. Dennis Ehlert (MS IS)
Amar Kamble (MS IS)
Mark Loudon (AG)
Anish Anand (AGI)
Nagendra … (AGI)
+ whole team
Q&A
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
Backup Slides
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Signal Management with agSignals | Dr. Yusuf Tanrikulu
Signal Management (SM) Process
Detection
Validation
Evaluation
Decision
Internal
agSignal reports
Identified Risk
External
HA requests,…
Potential Risk
Potential
association
Signal
No
No
No further actions
30 days
Day 0
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Signal
Evaluation
Report
- Risk mitigations
- Benefit-risk
assessment
Benefit-risk
& actions
Signal Refuted
Day 80
+ 10 days
to close
SM Process to agSignals Workflows
Detection
Validation
Triage WORKFLOW
TRIAGE
 List of cases
 Statistical report
 Close monitoring
Decision
Signal Management WORKFLOW
VALIDATION
Automatically
created workflow
Evaluation
EVALUATION
DECISION
Manually
created workflow
Validation status:
Recommended status:
Final status:
Signal Validated
Signal Not Validated
 Identified Risk
 Potential Risk
 Refuted Signal
 Identified Risk
 Potential Risk
 Refuted Signal
Signal detection and management provided within a single workflow system.
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Backup: Intra-Product Reporting Ratio (iPRR)
 Compares reporting frequency
of single drug-event pair
during a defined time period
to number of occurences
before the period
P/E pair
Start of
PVDB
What is known so far
Reviewing period
Events before period
Events in period
-1M
Signal Management with agSignals | Dr. Yusuf Tanrikulu
Today
Examples:
P/E pair
iPRR = 2
P/E pair
iPRR = 0.5
 a1 
 
A
iPRR   
 b1 
 
B
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iPRR = 1
Frequency of PT1
in time period
Frequency of PT1
before time period
Reference: SOP GDS 01 / WI 07 / RT 02

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