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Lessons learned from risk-based monitoring deployments

Using on-demand data to optimize trial execution

Dan White
VP, Global Operations

Amanda Sax
Sr. Director, IPT Quintiles

Copyright 2013 Quintiles

The New Health demands change


Trial complexity Regulatory scrutiny Development cost

Reimbursement Pipeline of compounds Physician pool

Competition for subjects

Post approval commitments

R&D spend
ROI Probability of success


Data-driven Trial Execution

Whos Ready for RBM?

Moving through Early Adoption Phase

From recent market research: Risk-based monitoring (RBM) has a high level of awareness among key decision makers in the biopharma industry (79%), up from 65% one year ago.
> Half have already implemented some aspect of RBM The major benefit is the promise of reduced costs (78%). Triggered monitoring (monitoring that responds to operational/data signals) is the most commonly-adopted aspect of RBM About 60% of non-users plan to implement RBM in the next 2 years. Within the next three years, 81% of non-users expect to be using RBM. in a clinical trial

Data-driven Trial Execution

So why isnt everyone using RBM?

Potential Barriers

While both users and non-users agree that RBM contributes to quality control and data accuracy (73%), there is also consensus that RBM involves at least some sort of trade-off between risk & quality (76%). For users, the major barriers to RBM implementation are concerns over investigator compliance if not visited every 6 weeks (49%), and the lack of face time between on-site CRA and investigator (44%). For non-users, the biggest barrier is the organizations corporate culture (52%). concern over being an early adopter / guinea-pig (40%).

Data-driven Trial Execution

Experiences Speak Loudly

From 10+ years of RBM deployments

This presentation provides insights into experiences in developing, refining, and implementing risk-based monitoring, and the role of such monitoring in data-driven trial execution. These represent lessons learned from more than a decade's employment of risk-based monitoring strategies including:
the selection of a core monitoring triggers, the articulation and continuing re-articulation of the thresholds employed, the role of technology and automation, and achieving the optimal balance of standardization and customization on a trialby-trial basis

Data-driven Trial Execution

rSDV in Late Phase Outcomes

Use Case #1: Trend Detection

The monitoring option chosen involved conducting SDV of a subset of selected subject visits only, chosen at random prior to onsite visit.
Some potential quality issues and trends went undetected. SDV strategy was revised and centralized trend analysis introduced utilizing aggregated data.

Lessons Learned: Random sample SDV by visit alone doesnt allow for onsite monitors to effectively detect quality trends at a site level. Sites' compliance monitored through aggregated data, has now become a core component of RBM.

Data-driven Trial Execution

Study Quality
Protocol Deviations Solution

Identify sites with quality risks and implement mitigation strategies Early signaling of site compliance to the protocol, GCP compliance Early signaling of study risks in trends; potential protocol adjustments can be identified Early signaling of under-reporting
Data-driven Trial Execution

Deploying Triggers
Use Case #2: Development program across a single compound

Assumption of high number of triggers ensures you wont miss quality issues. Triggers lead to excessive noise and loss of operational efficiency

Lessons learned were threefold:

> Focus on a few core triggers to drive quality and efficiency > Conduct upfront risk assessment to identify focused custom triggers > Find ways to harness technology, i.e., automating and aggregating data in a model was likely to be the optimal approach

> obtains the correct balance between the standardization, or industrialization, of the process and the customization needed for each study on a trial-by-trial basis. > allows for laser focused modifications to be made as needed in a particular study or development program.

Data-driven Trial Execution

Getting Smarter
Use Case #3: Large morbidity and mortality outcomes study

Next generation of study requirements: a 'smarter' approach

> Automatic triggering of onsite visits > Carefully chosen, critical set of thresholds > Deployment of resources solely dependent on trigger tool

SDV backlog grew at excessive rates! Lessons learned

> Technology can be utilized effectively if set up appropriately > Automated triggers still require some manual oversight > Reassessment of trigger thresholds is required with preference for assumption to be based on a statistical foundation

Data-driven Trial Execution

Data-driven Trial Execution

Data-driven Trial Execution begins with an in-depth risk assessment, where our team of experts evaluates the scientific and operational risk of each protocol.


Quintiles Infosario

Data surveillance allows us to optimize and adapt monitoring throughout the trial, re-assessing risk and applying the right action at the right time.

We use the right type of monitoring at the right time (on-site, remote, centralized), monitoring sites, data, patients and events that require more attention and focus.

Data-driven Trial Execution


New Monitoring Model

Focus resources based on risk

Balanced relationship between on-site and centralized monitoring improves delivery & quality, leading to better trial performance
Centralized Monitoring On-site Monitoring
Informed Consent Process & IP On-Site Relationship Source Document Protocol Medical and Data Monitoring Virtual Relationship Site Progression Management

Site Risk




Responsive Action Based on Level of Site Risk

Data-driven Trial Execution

The Benefits
Data-driven Trial Execution enables better, faster decisions, increased transparency, improved patient safety and quality, and more efficient trial management.

KnowledgeDriven Trials

Better, Faster Decisions


Quality Efficiency & Productivity

Efficiency & Productivity

Based on the experience and scientific knowhow of Quintiles

Immediate access and interpretation of trial, patient and other relevant data

A data-driven, near real-time view into data

Maintains quality, patient safety and regulatory compliance

Reducing the resources, time or cost required

Data-driven Trial Execution


Questions & Wrap-up

Thank you for your interest today!

Real Case Studies what are your experiences? What elements of RBM have you implemented? What approach is optimal for what types of studies?

Data-driven Trial Execution