RbM Webinar Slides- A Practical Guide for Getting Your RBM Program Up and Running

A Practical Guide for

Getting your RBM

Program Up and

Running

Thursday 21st January 11am ET / 4pm GTM

Getting started with risk assessment

Identifying and designing risk

indicators

Quality oversight and management

Risk Mitigation

Practical application of technology to

support all stages of RBM

Illustrate the process of using the

outputs of protocol risk assessment to

identify protocol risk indicators

Illustrate the process of designing

protocol risk indicators

Explore the characteristics of good

indicators of site quality risk

Explore the practical application of

surrogate risk indicators in RBM

Duncan Hall, CEO, Triumph Research Intelligence

Duncan is the founder of both Triumph Consultancy and Triumph Research Intelligence which have been operating for 14 and 3 years respectively. He has over 15 years of industry experience and has run strategic and operational systems implementation and optimization projects for multiple CRO and pharma companies.

The Risk-basedmonitoring company

Founded in 2013

Sister company to Triumph Consultancy

Entirely Quality Oversight and RBM focused

Creators of OPRA RBM platform

One complete solution

Implementation services

Study specific services

Technology

Hosting

General Consultant14%

Interested Party17%

Expecting to be part of team26%

Part of RBM team43%

Audience Breakdown

Presentation Synopsis

• Your RBM goals and aspirations

• Getting started with risk assessment

• Identifying / designing risk indicators

• Quality oversight and management

• Risk mitigation

• Application of technology






• Risk mitigation


Where do we start and where to

we want to get to?

Risk assessment

Risk reductionRisk

identification/ management

Quality oversight evidence

Informed monitoring

Adaptive monitoring

RBM Maturity

Protocol assessment

and documentation of

risks and risk categories

Mitigating risk through

protocol design and early

risk reduction actions

KRIs and thresholds for

risk identification and

management plans

Centralized evidence of risk

measurement and activity over

time – traceability to risk

assessment

Using information from RBM system to inform

monitor what patients and data to focus on,

and other underlying issues with site

Using data to drive

monitoring patterns

and efficiency

(Top 10 CRO case study)

4x lower error rate

in critical

data compared

to traditional 100%

SDV

45% reduction in

number of

missing

pages 47% higher

Action Item closure

30%reduction in

SDV backlog

4x more study

sites enter data

within 7 days

52% fewer

queries aged

> 10

days

Up to 25%cost savings

What benefits do you want to achieve?

Audience Poll

What are you expecting to get from RBM?

1 - Meet the regulatory requirements for risk

assessment and quality oversight

2 – The above plus improvements in quality

and safety

3 – The above plus efficiency / cost saving






• Risk mitigation


e.g. procedures driving data related to primary objectives

e.g. assessments which don’t relate to core objectives

Which Risks Do We Manage?

Evaluate Protocol Risks

Structural Risks

Essential Risks

Revise Protocol

Plan to manage and

mitigate

What is the process of risk assessment?

Categorized questions

Core KRIs

Pre-defined relationship

Risk Scores

Individual Risk

Category

Protocol

Critical data / processes

Risk management

Summary

Risk Assessment Tool / Engine

KRIs

Thresholds

Category

Hierarchy

Study plans

Data / process monitoring plan

The ‘Goldilocks’ Test

How many

indicators

should I use?0 10 15 20 30+

Not enough information ‘Just right’ Too much noise






• Risk mitigation


Something for Nothing! – Top 10 KRIs

CATEGORY – This tells us the indicator category, and allows us to group indicators according to purpose

DESCRIPTION – How is the KRI derived?

DATA REQUIREMENTS – What data is needed for the KRI and how are the calculations performed?

WHAT ARE WE LOOKING FOR? – What is the KRI telling us in real world terms?

ADDITIONAL COMMENTS – Is there anything else we think you should know?

COMPANION KRIs – Are there any other KRIs we recommend using in conjunction with this one?

Regulatory Guidance

• Need to assess protocol risks.

• Monitoring focus should be on protocol risk factors.

• There should be a relationship between risk assessment and risk measurements or risk indicators.

Examples

AE rates

Inclusion / exclusion deviations

Enrolment rates

Early term rates

Data Entry timeliness

Query rates

Image quality assessment

Dose changes

Core KRIs

• Many KRIs used to detect site quality risk will be standard.

• Core KRIs are often associated with safety and performance, but they can also be surrogate markers for quality risk and should be monitored and managed.

Study KRIs

• Designed to assess and monitor the critical data and processes for a study.

• KRIs may also change during the course of a study, due to risk factors changing as the study progresses e.g. once enrollment is complete.

Core or Study KRIs?

Let’s work through designing a quality indicator to assess risk around the critical data

Endoscopy images

KRI Definition Example

Site creates test image

Site sends test image to central

reader

Image is received

Image quality is assessed

Test image is accepted

T1 Q1T2 T3

Pre FPI

Site conducts subject

endoscopy

Site sends image to central reader

Image is received

Image is assessed

Image is reported

T4 T5 Q2

Post FPI

Image reporting timeliness

Time to image acceptance plotted as % missing or reported after 10 days of procedure

What Should It Look Like?

What Should It Look Like?






• Risk mitigation


How do I get from risk assessment to risk

management?What risks are

we going to

manage, and

which KRIs Do

we use?

What function

is best placed

to manage

that risk?

What does

that function

do when the

risk looks to

be present?

Risk assessment and categorization

Cross functional planning

Functional quality risk management plan

How do I get from risk assessment to risk

management?

What does

that function

do when the

risk looks to

be present?

Functional quality risk management plan

• Monthly team review of patient withdrawal rates

• If site indicator is orange, add observation and review next month

• If site indicator is red, review companion metrics

• If companion metrics indicate abnormal data pattern, review source data

• If source data shows potential issue, add action to review data with site.

Patient Withdrawal Rates

Wit

hd

raw

al /

10

Su

bje

ct V

isit

s






• Risk mitigation


How Do We Use KRIs Practically?

KRI• Does the KRI show risk?

• E.g. Higher than study average withdrawal rate

Companion• Review companion metrics

• E.g. Withdrawal type vs.

study norms

Data • Review data

records

Deeper dives

should be

possible at to

refine the risk

signal and

determine actions

Adverse Events Region 2

What are the main

reasons for patient

discontinuation?

What is the

distribution of

reasons across

all sites?

What is the

distribution for this

site?

Companion

Metrics

Drill down to the

KRI data set

What is the

distribution for this

site?

Sort, group and export

multiple data sets for

comparison

Risk Mitigation – What actions?

Actions will be driven by your data monitoring and risk management plans

Should be driven by what you see in the data – reg authorities want to see traceability

Actions may be:

General – an issue across all sites, or a cluster of sites

Site specific – site has breached a KRI threshold or showing a pattern of behaviour we want to

investigate

Patient specific – we think these patients may be at risk from safety or quality perspective

Data specific – we want to SDR a certain subset of a site or patient’s data

Other – depending on protocol and risk assessment

We need to ascertain if the actions have been executed and whether they were effective –

learn and adjust

Risk Mitigation – Is it working?

Risk Mitigation – Is it working?

Summary

Define what RBM means to you and what benefits you want to achieve

Process of starts with Protocol assessment and design

Remove structural risk early

Define KRIs for essential risk and assign appropriate function

Create functional quality risk management plans

Review data and execute risk manage activity as needed

Use companion indicators and data review to perform root cause

Track everything – build your evidence and learn for the next study

If you want help – ask – we’re here to help!

Questions / Contact Details

Duncan Hall

CEO and Founder

By website:

www.tritrials.com

By email:

[email protected]

TRI – Where’s The Risk?

Join the official LinkedIn RBM Group, Risk-Based Monitoring in Clinical Trials and follow our LinkedIn Page, Triumph Research Intelligence!

Follow us on Twitter @TRI_OPRA_RBM

Visit us on www.tritrials.com or email at [email protected]

Thank You

…the risk-based monitoring company

http://www.tritrials.com/

mailto:[email protected]

Date post:	18-Jan-2017
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RbM Webinar Slides- A Practical Guide for Getting Your RBM Program Up and Running

Health & Medicine