Webinar on Risk Management in Clinical

W E B I N A R

By Jane Tucker

Stay Tuned…

What are we going to cover

• Introduction

• DDi & TULA

• Topics in Risk Management in Clinical Trials

Basic risk management methodologyBasic risk management methodology

Utilize the basic principles to take a 'risk-based approach' to a clinical trial

Document risks identified

Prioritize risks and plan mitigation actions where necessary

Tools utilization for effective management & automation

• Q & A

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Our Speaker - Jane Tucker

• 30 years in the pharmaceutical industry• 30 years in the pharmaceutical industry Jane has been involved in a number of different disciplines

• Jane specialized in Quality Risk Management, facilitating risks assessment sessions, documenting and managing risks and training staff in risk management

• More than 5 years hands on experience risk• More than 5 years hands on experience risk management within clinical trials, process improvement and software development projects

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DDi & TULA

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Operation in 7 Key Countries across GlobeOperation in 7 Key Countries across Globe

750+Successful Clinical Trials

Smart Products: mEDC, mIRT, mPORTAL, safeXchange

Smart Solutions: ClinMetanoia, TULA, dattasa

55 Copyright @ 2015 DDi. All Rights Reserved

• TULA is an effective Risk Management Solution that aids conversion of risks into opportunities.

• A Solution which will focus on areas that present the greatest

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risk to human safety and data integrity.

Copyright @ 2015 DDi. All Rights Reserved

BenefitsFeatures

A platform to monitor full cycle of a project or portfolio of projects

Reduce number type and severity of

All Risk management activities at 1 place

Reduce number, type and severity of events

Interactive dashboards and reports

Timely alerts and escalation

Standardizing Risks

Effective Metrics management

Timely alerts and escalation

Audit trails and role based accountability

Easy integration

Reduce Compliance issues


Basic Risk Management Methodology

8

Regulatory Background to Risk Management and MHRA Expectations

ICH Q9 Quality Risk Management

Two principles

The evaluation of the risk to quality should be based on scientific knowledge and ultimately linked to the protection of the patients

The level of formality, and the documentation of the quality risk management process should be commensurate with the level of risk

9 Sue Fitzpatrick Associates 2015

ICH Q9

Overview of a typical Quality Risk Management Process

InitiateQuality Risk Management Process

Overview of a typical Quality Risk Management Process

Risk Assessment

Risk Identification

Risk Analysis

Risk Control

ation

Risk Ma

Risk EvaluationUnacceptable

Risk Com

mun

icanagem

ent Tools

Risk Reduction

Risk Acceptance

Output/Result of theQuality Risk Management Process

1010

Risk Review

Review Events

Sue Fitzpatrick Associates 2015

What is Risk Management?g

1 1 -- IdentifyIdentify

22 Anal sisAnal sis

5 5 -- ControlControl

2 2 -- AnalysisAnalysis

4 4 -- TrackTrack

Sue Fitzpatrick Associates 2015 11

3 3 -- PlanPlan

What is Risk Management

• Risks assessment to identify risks

• Analysis to priorities the risks

I t ( )Impact (or consequence)

Likelihood (or probability)

.. and now Detectability

• Planning to manage ONLY the most significant

• Track …... then Control

• NOT a tick box exercise!!!NOT a tick box exercise!!!


What is Risk Management

Ri k i di i li h dd• Risk management is a discipline that adds benefit to any activity

• Risk management ensures that all available resources are utilized where they add the greatest benefit

• Risk management ensures that tasks that areRisk management ensures that tasks that are 'always done', but may not necessarily be mitigations for a significant risk, can justifiably be left undone


The 5 Steps of Risk Management?

1 Id if1 – Identify

• What is the root cause?

• What is the risk?

2 – Analysis

• What is the impact/consequences?

• What is the likelihood?

Communicate at all times


Risk of Scoring Matrix

VERY HIGH (5) 9 16 20 23 25

HIGH (4) 13 18 22 247

LIHOOD MEDIUM (3)

LOW (2)

4

2

11

6

15

12

19

14

21

17

LIKE

LOW (2)

VERY LOW (1)

2

1

6

3

12

5

14

8

17

10

IMPACT

VERY LOW (1) LOW (2) MEDIUM (3) HIGH (4) VERY HIGH (5)

1515

IMPACT

Sue Fitzpatrick Associates 2015


3 – Plan ‐ ONLY for the most significant risks

• What can be done to lessen the impact?p

• What can be done to reduce the likelihood?

• What can be done to increase the detectability?

• Can someone else handle this better?

Communicate at all times



4 T k4 – Track

• Are the planned actions being implemented?

• Are the responses effective?p

5 – Control

• Is the original risk under control?

• Have any changes occurred?

• Are there any new risks?

Communicate at all timesCommunicate at all times


How to structure a Risk Statement

Risk statements need a root cause ‐ Because of .....

• Because of• Because of .....

• … there is a risk that .............

• … resulting in ........................

• Because eDiaries may not be accepted by patients there is a risk that vital data are not collected resulting in compromised statistical analyses

• Because stocks and shares can go up as well as down there is a risk that the value of investments may decrease resulting indecreased capital



What are the advantages of a statementWhat are the advantages of a statement structure?

Detailed enough to be understood by anyone who reads itby anyone who reads it

Risk Registers or Risk Logs may need to be passed down through

b f j t t dmembers of a project team and can stand the test of time



How the statement structure can add benefit

The relationships between risks arising from the same root cause arearising from the same root cause are clear

It can clearly been seen where one iti ti ti t llmitigation action can actually

mitigate a number of risks


How to Structure a Risk Statement

• Because of .....

• … there is a risk that .............

• … resulting in .......................

• Because eDiaries may not be accepted by• Because eDiaries may not be accepted by patients there is a risk that vital data are not collected resulting in compromised statistical analysesanalyses

• Because eDiaries may not be accepted by patients there is a risk that Investigator sites may not want to be involved resulting in lack ofmay not want to be involved resulting in lack of power for the statistical analysis


Utilize the Basic Principles pto take a ‘Risk-Based Approach' to Clinical Trials and Programs

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How to utilize Risk Management in a Clinical Trial

Clinical trials involveClinical trials involve

• Human subjects/patients

• Unlicensed chemical entities

• Scientific advancements

• Contractual agreements

• Huge amounts of time/money/resources• Huge amounts of time/money/resources

• Corporate investment

• Public perceptions/opinions

• ............................!!!!!!!!!!


Why & How

• Patients want to know they are safe

• Regulatory authorities need assurancesg y

• Contracts/legal requirements must be met

• Approval for budgets must be obtained

• Corporate image must be maintained

• Public opinion must be shaped


How to get started

Any time!!


Integration into a clinical trial

Write protocol and IBStart to identify root causes

Select sites and gain approvalsIdentify all risks, analysis and plan responses

Recruit patients Track responses and identify/analyse/plan

Collect/clean data and monitor sitesCollect/clean data and monitor sites

Control responses and identify/analyse/plan

Finalise databaseStats Analysis and report


Initiate Project


How to Utilize Risk Management in Clinical trial

• Start with identifying the 'stakeholders'Start with identifying the stakeholders

Study team lead

Data management

Clinical trial supplies

Monitor

StatisticianStatistician

Principle Investigator

Representatives of contractors

..... etc


How to Utilize Risk Management in Clinical trial

• IdentifyP t ti l R t C l t d tPotential Root Causes related to clinical studies

RecruitmentUse of technologyUse of technologyResources.... etc.

Then brainstorm risks related toThen brainstorm risks related to each root cause

• AnalyseAgree Impact/Consequence and LikelihoodDerive the Risk Score or Risk Level


How to Utilize Risk Management in Clinical Trials

• Plan ‐ ONLY for the most significant risksIdentify the actions to be takenIdentify the actions to be takenIdentify who will actually perform those actionsWhen does the action need to be reviewed?

• TrackAt regular intervals the Study Team should review progressshould review progress

• ControlAs the study progresses regularly review the Risk Register or Risk Log and check for any risks that can be closed or new risks arising


When & Who?

• Write Protocol and IB

Who is involved at this stage?

Core trial team members

Drug development team representatives

.... any others?

Risk Management activities

What risks have been identified by the drugWhat risks have been identified by the drug

development team that need addressing?

Identify risk triggers related to phase, study

population and locations, PK and PD results,

etc.......


When & Who?

• Select sites and gain approvals

Risk Management activitiesTake all previously identified risk triggers and

use those as a basis for a brainstorm on

potential risks

Once brainstorm is complete risks should be

scored and prioritized

Responses should then be agreed ONLY for the most significant

Ownership of the responses and time‐frames should be documented in the risk register/log etcshould be documented in the risk register/log etc


When & Who?

R i P i• Recruit Patients


• Collect/clean data and Monitor sites/


• Finalize Database


• Stats Analysis and Report

Who is involved at this stage?Who is involved at this stage?


Risk Documentation

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Remember to Structure Risk Statement

• Because of .....

… there is a risk that .............

… resulting in ........................

• Build your risk documentation around that• Build your risk documentation around that structure initially


Risk Identification


What should Risk Documentation look like?

• Whatever works for you!!

• 'Team' friendly

N t t h d t ilNot too much detail

Not too technically complex

Accessible by everyone who is on the team or owns responses

Managed by one person


What should Risk Documentation look like?

• Need some easy way of uniquely identifying

each risk to ease tracking and communication

• Multiple risks in rows per sheet rather than one• Multiple risks in rows per sheet rather than one sheet for each risk

• Spreadsheets make for easy sorting by Ids/ Risk Scores/Owners/Due DatesScores/Owners/Due Dates

• Include a method for tracking ongoing progress

• Call it a Log, Register, RMP .... whatever!!!


When & Who?

• Minimum contents

Risk ID – numeric or alphanumeric, sequential

Risk statement

Risk score

Response (or N/A)Response (or N/A)

Response Owner

Response Actions (if necessary)

Response Due Date


Risk Documentation

Risk Driver Root CauseBecause

...there is a risk that

...resulting in...

Impact(Very Low=1

Low=2Medium=3High=4

Likelihood(Very Low=1

Low=2Medium=3High=4

Risk Score Action Owner(s) Review by(dd/mm/yy)

Because of...

Very High=5) Very High=5)

Because eDiariesmay not

there is a risk that

resulting in

iay obe

accepted by

patients

s avital data are not collected

compromised

statistical analysis

4 3 19


Risk Documentation


Risk Documentation (Register)


How Risk Management adds value

• Everyone who participates in the risksEveryone who participates in the risks assessment will have an understanding of the whole picture and where the problems are likely to be

• The whole team gets to meet at the outset

• There are never adequate resources available, but risks assessments ensure that resources are allocated where they will deliver greatest benefitbenefit


How Risk Management adds value

• Once risks are identified scored and prioritized• Once risks are identified, scored and prioritized, it is then possible to justify to senior management why some actions are NOT being under‐takenunder taken

• The whole team meets, and starts to communicate, from the beginning and as such make a really positive start

• It is a structured process, that sets a good discipline across the team


P i iti Ri k d PlPrioritize Risks and Plan Mitigation Actions where necessaryy

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Prioritization of Risks

• Use that scoring from the Impact and Likelihood

• Sort the list of risks by score to get the biggest at the top

• Review the whole list as a team and determine how far down the list you will aim to go initially (you may only take on the top 10 risks)


What to do about the Risks

• Responses to risks can take 4 forms

Avoid – i.e. make major changes

Mitigate – i.e. take action to reduce likelihood or impactor impact

Accept – i.e. take no further action

Transfer – i.e. pass the risk to someone else


Risk Mitigation


How do you decide What actions to take and How to manage them?

• Only take action if the risk is high priority

• Only take action if it is within your sphere of influenceOnly take action if it is within your sphere of influence

If it's not, can you transfer the response to someone else?

i h ld b d b h i l• Actions should be owned by the appropriate people

The person who will actually do the work

Not the 'Team Leader' for everything!! y g


How do you decide What actions to take and How to manage them?

O i k d l i l i• One risk may need multiple actions

That's OK ‐ but each action needs an owner

Track the progress for each actionp g

• Only allocate one person as many actions as they can actually manage

• Start with the most significant risks and work down the• Start with the most significant risks and work down the list in order of priority, that may mean only tackling

3 or 4 risks at the start


Risk Tracking


Risk Management Results

• Any risk management activity will improve the quality of your trial – mainly by limiting waste of resourcesof resources

• The study team will be focussed on the activities that will deliver maximum benefit

Th t ti b b d th• The team meeting can be based on the progress of risk management activities


Summary

There are 5 steps within risk management andThere are 5 steps within risk management and a regulatory Expectation of a ‘risk based approach'

All members of the clinical trial team should beAll members of the clinical trial team should be involved in the risk management for the trial.

Risk Management should be an ongoing process through‐out the whole trialprocess through‐out the whole trial

Risks can be documented in any way that the team finds helpful, as long as it is regularly reviewed and updatedreviewed and updated


Thank you for your time !Thank you for your time !

For any questions, please email to

5454

For any questions, please email [email protected]

Webinar on Risk Management in Clinical

Health & Medicine

Transcript of Webinar on Risk Management in Clinical