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Risk Management – Good vibrationsPhUSE 2017
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Risk Management • The art of good vibrations
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A risk under the magnifying glass
Based on
uncertaintyExist in the
future
More things
might happen
than will happen
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Risks vs Issues
Risks
• Might happen
• Uncertainty
• Pro-active
Issues
• Is happening
• Certainty
• Re-active
• Can become an issue
• Can be a former risk
impact on
objectives
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Elements of a risk – The risk bow tie
Cause
Cause
Consequence
Consequence
Consequence
Consequence
Risk event
What can trigger the risk? What can happen if the risk occurs?
Proactive actions Mitigation actions
Recovery actions
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Probability Impact Severity
Understanding the risk
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Risks are not individual problems in a confined space
Risk
Risk
Risk
Risk
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The key to success is a well-crafted web
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The elements of a risk spider web
Risk Appetite Statement
Risk Culture
Risk Management Strategy
Risk Management Plan
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Risk Management is a effort
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Benefits of a great working spider web
Increase the likelihood of realising objectives
Build confidence
Comply with relevant legal and regulatory requirements
Improve resilience and quality
Optimise allocation of resources
Improve organisational learning
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Risk Management is the art of
good vibrations
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Risk Management in Clinical Trials
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ICH E6 (R2) – New Good Clinical Practice
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ICH E6 (R2) – our challenges
The regulators don’t have a consistent understanding of risk
The industry doesn’t understand what risk is and how to manage it.
Agencies will mature their own interpretation over time .
Everyone is starting from a different place
Cultural change takes longer as we have a history of managing issues rather than risks
Each organisation has their own interpretation of the guidance
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Risk Management as an Opportunity
ICH E6 (R2) is an opportunity to implement risk management
Through risk management we can prevent unpleasant surprises
It is not just about being compliant
Increase the quality of our programmes through Quality by Design
Take control over cost and resources when risks turn into issues
Learning cycles will support improved process and trial design
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RISK MANAGEMENT needs to become part of our DNA
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Interpreting ICH E6 (R2)
System Level
• CROs & Vendors• SOPs• Computer Systems• Facilities • Study Design
• Protocol Development• Investigators Role
Trial Level
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Risk Breakdown Structure (RBS)
Aligning Metrics with business need
Data, Metrics &Performance
Quality Management System
Aligning Standards
OrganisationStructure
Documentation
On-Boarding BusinessProcesses
Audit &Compliance
CROSelection
Clinical Trial Conduct
InspectionReadiness
• Social• Technological• Economic• Environmental• Political• Legal• Ethical
CRO GCP Quality Risk
Macro –Environment
Factors
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Pro-active management enables efficiency
Low
High
Time
Proactive Risk Management
Cost of implementation
Potential for mitigation
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Rev
iew
5.0.6 Risk Review
Co
ntr
ol
5.0.4 Risk Control
Adapted Process Flow ICH Q9 (consistent with Addendum ICH E6)
Risk Management Framework – Learning Cycle
Co
ntr
ol
Res
po
nd
Ass
ess
Create Risk Breakdown Structure
Risk Identification
Risk Analysis
Risk Evaluation
Risk Reduction
Risk Acceptance
Output / Results of RM Process
Review Events
Ris
k C
om
mu
nic
atio
n a
nd
Rep
ort
ing
Ris
k M
anag
emen
t To
ols
Un
acce
pta
ble
5.0.1 Critical Process and Data Identification
5.0.2 Risk Identification
5.0.3 Risk Evaluation
5.0
.5 /
7 R
isk
Co
mm
un
icat
ion
an
d R
epo
rtin
g
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Different levels of risk
• Social• Technological• Economic• Environmental
CLINICAL PROGRAM
BUSINESSLEVEL
MACRO ENVIRONMENT
• Business Objectives• Operational Objectives (Cost, Quality, Time)
• Study Set-up• Study Conduct• Study Closure
• Political• Legal• Ethical
Risk is at the heart of what we do
TIME
COST
QUALITY
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The Risk Bow Tie – an example
Trai
nin
g
Reputation
$$$
Power of Trial
Tho
rou
gh
inve
stig
atio
n
What can trigger the risk? What can happen if the risk occurs?
Controls / Proactive actions
Mitigation actions
Recovery actions
Insufficient Systems
Another cause
Syst
em
up
dat
es
Po
licie
s
Ch
ange
m
eth
od
s
Take
ou
t in
vest
ig.
Tigh
ten
d
etec
t.
met
ho
ds
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Multiple connection points, many people
handling data
Sensitive data is disclosed
Vendors’ use of service providers
Loss of sensitive customer data
Regulatory fines
Classifying data for business or regulatory use
Causes
Early warnings for data compromise
Preventative actions / controls
Mitigation Actions Consequences
Risk example
Human error in documenting data
Limited options for vendor selection
Data loss prevention techniques (DLP)
3rd parties to adopt data controls on safeguarding
Vendor assessment process
Data encryption controls
Employee training and refresher education
Checking & verification processes in place
Review sourcing strategy
FDA approvals delayed
Integrity of trial compromised
Time contingency plans
Evidence of oversight in TMF
Extend clinical trial
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25
20
15
10
5
Risks over time
Time related information will support better prediction of risk…
Time
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Technology in Action – the Risk Bow Tie
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Heatmaps Provide a Great Focus for Clinical Teams
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Risk has many facets
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Taking full advantage of ICH E6 (R2)
…of processes to effectively identify and evaluate risk
STANDARDISATION
Implementation of an aligned framework
RISK MGTFRAMEWORK
INDEPENDENT MANAGEMENT
across you as the sponsor and your vendors/CRO’s.
risk register, presentation of risks,
profiles and risk scores.
TOOLS
methods and toolset
TRAINING
Employee involvement towards proactive risk
management
CULTURE
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In the middle of difficulty
lies opportunity. Albert Einstein