Embracing Risk in Clinical Trial Monitoring James Streeter Senior Director Life Sciences Product...

Embracing Risk in Clinical Trial Monitoring

James StreeterSenior Director Life Sciences Product StrategyHSGBUOctober 2, 2014

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Safe Harbor StatementThe following is intended to outline our general product direction. It is intended for information purposes only, and may not be incorporated into any contract. It is not a commitment to deliver any material, code, or functionality, and should not be relied upon in making purchasing decisions. The development, release, and timing of any features or functionality described for Oracle’s products remains at the sole discretion of Oracle.

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Copyright © 2014, Oracle and/or its affiliates. All rights reserved. | 4

Strategy

Life Sciences

Healthcare

Convergence

• Accelerate clinical development• Support entire drug safety lifecycle• Enable clinical data aggregation

• Power enterprise healthcare analytics • Enable provider/payer integration• Drive personalized medicine

• Intersection of clinical trials and clinical care• Develop collaboration networks for providers

and life sciences companies

Copyright © 2014, Oracle and/or its affiliates. All rights reserved. | 5

Oracle delivers advanced transformative value for clinical R&D in a modular, integrated and scalable cloud environment and helps you:

Clinical Research and Development Solutions

Delivering End-to-End Value

Optimize OperationsWith technology that helps you maximizeefficiency across your clinical life cycle

InnovateBy incorporating genomics, biomarkersand real-world patient data

Future-Proof your BusinessWith a platform that evolves and grows with you and the industry

Gain Actionable InsightsFrom aggregated clinicaland healthcare data


Risk Based Monitoring• Embracing Risk in Clinical Trial Monitoring

– Current state of risk-based monitoring– Why sponsors and CRO’s are shifting to comprehensive, real-time analytics –

• Integrated with trial management• Mobility• Data from any standards-based EDC system – • The technology backbone to effectively conduct a strategic risk-based monitoring program.

– KRI’s– Limitations of current eClinical technology– Challenges– Summary


Risk Based Monitoring• Why Monitoring is required?

– Patient safety– Eligible patient enrollment– Protocol compliance– Accurate data collection

• Paradigm shift…a more targeted, centralized, and risk-based approach to Monitoring– Improve resource efficiency– Increase quality of trial conduct and data collected– Maintain or reduce study timelines– Reduce overall study costs

• An industry that has been risk adverse


Key Drivers for RSDV through technology–Only 2.4% of critical data is queried on average–Quality focus

• Site and data• Increasing safety

–Streamlining drug development• Getting more drugs to market to help patients

–R&D pipeline• Reducing risk for financial investment• 10 to 40% cost savings needed over the next 3 to 5 years

–Travel cost –Resource cost–Site time


RSDV Industry Investments• CRO’s and sponsors investing millions to implement RSDV– Standardizing data and processes– Creating KRI’s

• Operational focused• Infancy in what is working and what is not.

– Introducing new business process and change management• Business Intelligence (BI)tools

– Integrating systems and data – platform approach

• Next focus– Focus on data quality algorithms, not just operational data– Business process management tools– Artificial intelligence


Industry Initiatives

• Regulatory drivers– FDA, MHRA, EMA

• Guidance document on eSource Data Collection• Oversight of Clinical Investigation – A Risk-Based Approach to Monitoring

• Clinical Trials Transformation Initiative (CTTI)– Quality by design (QbD)

• Transcelerate– Building QbD into trials– Early and ongoing risk assessment– Focus on critical processes and d– Use of risk Indicators through trial


Risk Based Monitoring Platform from a Technology / platform perspective (Current)

Analytic SystemsCTMS

Monitoring (if separate from

CTMS)

Paper, EDC / IVRSCDM

eTMF

Safety / Surveillance Systems


Risk-Based Monitoring Oracle’s Multi-System Holistic Approach

Siebel CTMS Suite Integration & Open Interfaces

External 3rd Party Data, ProgramsInForm

Argus

OC/RDC

Life Sciences Data Hub

Empirica Study Empirica TopicsRisk Analysis

Argus AnalyticsClinical Development Analytics

Customer PortalMobile CRA

Clinical Dashboards & Reports

ClearTrial

Provide continuous monitoring of study and site data

Support multiple methodologies for streamlining site monitoring through

targeted SDV

Single global safety repository ensuring risk monitoring of subject safety

Access to historical quantitative and qualitative site and investigator performance;

Lower costs leveraging Oracle’s pre-built integrations and open

interfaces to enable RBM Plans

Extensibility to incorporate data and programs from customer applications in

the clinical ecosystem (e.g. EDC, CTMS, Lab, ePro, eTMF, etc.)

Over 80% OOTB coverage of risk indicators identified in TransCelerate

position paper

Incorporating customer specific systems and processes via open interfaces

Enabling real-time access to actionable insights for decision making through

Mobility

Upfront risk based trial planning via ClearTrial


Siebel CTMS Suite Integration & Open Interfaces

External 3rd Party Data, ProgramsInForm

Argus

OC/RDC

Life Sciences Data Hub

Empirica Study Empirica TopicsRisk Analysis

Argus AnalyticsClinical Development Analytics

Customer PortalMobile CRA

Clinical Dashboards & Reports

ClearTrial

Risk-Based Monitoring Oracle’s Multi-System Holistic Approach

Provide continuous monitoring of study and site data

Support multiple methodologies for streamlining site monitoring through

targeted SDV

Single global safety repository ensuring risk monitoring of subject safety

Access to historical quantitative and qualitative site and investigator performance;

Drive down costs leveraging Oracle’s pre-built integrations and open interfaces to enable RBM Plans

Extensibility to incorporate data and programs from customer applications in the

clinical ecosystem (e.g. EDC, CTMS, Lab, ePro, eTMF, etc.)

Over 80% OOTB coverage of risk indicators identified in TransCelerate position paper

Incorporating customer specific systems and processes via open interfaces

Enabling real-time access to actionable insights for decision making through

Mobility

Upfront risk based trial planning via ClearTrial

GOAL: Enable Life Sciences customers to deploy Centralized

and Risk Based Monitor Strategies

By leveraging existing investments and Oracle technology to drive

down costs

While ensuring data integrity, subject safety and compliance


Risk Based Monitoring stages

•Planning–Identify, plan, and prioritize risk of studying the investigational product.

•Design–Define protocol eligibility criteria, efficacy, and safety risk factors during design; for inclusion in the eCRF edit build, as well as define key protocol deviations anticipated for study.

•Execution:–Clear direction in the oversight and monitoring of parameters leading up to study endpoints, integrated study level monitoring plan, clear direction on evaluating fraud.

•Analysis: –Clear definition of data measurement and reporting, defined elements of statistical analysis of protocol endpoints, safety, etc.

•Disclosure–Publish outcome data, bringing all the above together in the clinical study report (CSR).


Risk Assessments of investigators, site staff, and sites are key

• Protocol, a comprehensive risk assessment is essential to ensuring your risk based – Identify the risk factors unique to the investigational product, the program and

the protocol. – Define a risk based strategy,

• Identify the key data,

• Appropriate performance thresholds,

• Determine the appropriate monitoring levels for a specific protocol.

– Risks of the trial only solves part of the equation. • The risks of each individual site.

• Comprehensive risk assessment that focuses on site risk factors,

• Set each site up for success by defining a focused risk mitigation strategy.

– Benefits of a risk assessment that includes the evaluation of each site • improving site selection by stratifying sites based on key risk factors;

• establishing early mitigation plans for sites with higher risk;

• determining a site-specific monitoring level (prior to the study start) that is based on actual data; and

• assigning monitors and site managers appropriately, based on site risk.


Access to DataWe need data at it’s point of origin, original source.

This allows for real time analysisStill using manual/paper/independent collection rather than central sources for collectionsSites are beginning to have their own EMR, so need ways to communicate with their EMR

Collect on a central device that can be attached to their EMR and viewed by CRA remotelyAccess to their EMR – however, there EMR may not capture data in the form as specifically as we require


Subject Safety

Compliance & PerformanceDataIntegrity

Protocol Deviations

Data Entry & Approval

Data Cleanliness

Follow Up Items

Site Visit Frequency

Screen Failure Rate

Subject Withdrawal Rate

TMF Compliance

Clinical Supplies

SDV

Enrollment Rate

Subject Visits Out of Window

Visit Report Contents

Historical Clinical Data

Risk Categories & Key risk Indicators

SAEs

Current Clinical Data

Historical Site Performance

Historical Investigator Performance


Key Risk IndicatorsKey Risk Indicators

Must be in real timeMust be predictive, reliable and sensitiveMust be able to trend over timeMust be able to use data gathered within the study (rates, means, Standard Deviations) until established thresholds can be determinedThresholds may need to be customized by indication, therapeutic area or study phaseNeed to examine source of that data for reliability

Deviations self-reported by site not reliableDeviations captured by CRA’s while onsite not in real time or predictive

Need to be able to tap into historical data (site performance on other studies, similar studies, etc)


New and Changing Roles

Remote/Centralized CRAMonitors data across sites/subjectsCompares sites or subjects to other sites or subjectsMay communicate through onsite CRA or may be primary site contact

Data AnalystMonitors data across the study or a programCompares study against other studies or subjects against other subjectsFraud detectionCommunication passes through PM or CTM to CRA or site

Blurring/Overlapping of RolesDM and CRA PVG and CRA


Challenges to be expectedIntroduction of data with new risks

EMR and Patient devices

Introducing historic data outside of clinical studies

Lack of agreement between clients and vendors on the sharing of data – as a result of multiple service providers

This isn’t just about data, but about process and roles which are different company to company

As a result sharing data means putting differentiators at risk, particularly for vendors

Revenue shift in service providers


Risk-Based Monitoring CoverageOracle’s Platform Approach

Risk-Based Monitoring by Application

OC/RDC & InForm or

3rd Party

Applications Presentation

Ad Hoc Analysis

Proactive Alerts

MS Office Integration

Interactive Dashboards

iPhone / iPad Integration

OBI-EE

Clinical Development

AnalyticsArgus Safety

Or 3rd Party Safety

Siebel Clinical

Or 3rd Party CTMS

Mobile CRA

EmpericaInspections


TransCelerate Risk Based Monitoring White Paper

Solutions supporting Risk-Based Monitoring TodayInForm, CTMS, Mobile CRA, Clinical Development Analytics, Argus Safety, Empirica, Argus Analytics

Solutions with Risk-Based Monitoring Features PlannedOC/RDC, CTMS, Clinical Development Analytics, Trial Analyzer

Coverage of TransCelerate’s Risk-Based Monitoring Methodology by Oracle SolutionsOver 90% coverage of risk indicators identified in position paper with functionality and metrics found out-of-the-box in Oracle’s Analytics solutions

Clinical Development AnalyticsArgus Analytics

Additional or custom indicators can be easily added to the CDA Warehouse and/or Dashboard

Overview of Oracle Coverage


RBM SummaryRisk based monitoring is in its infancy

Regulatory agency are key supporter

Investments in RBM will continue, standardization is key

Key Stages- Planning, Design, Execution, Analysis, and Disclosure

Process and change management investments

New and changing role

Real time and historical data access is key

Platform approach is required

There will be challenges

Embracing Risk in Clinical Trial Monitoring James Streeter Senior Director Life Sciences Product...

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