clinical research - present status & future challenges ... · pdf filefuture challenges...
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Clinical research - Present status & future challenges
Applying new technologies forcost effectiveness, high data quality and patient safetyand patient safety
Gunjan JainPre Sales Head, South AsiaOracle Health Sciences
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Analysis & Submission
▪ Deliver cleaner data
faster
▪ Reduce Phase II-III
attrition
▪ Gather and analyze
usable real-world data
▪ Enhance patient safety
▪ Conduct rapid and
▪ Leverage genomic
and biomarker data
▪ Conduct fast and
in-depth data analysis
▪ Predict spend
accurately
▪ Optimize for cost/
schedule/resources
Trial Conduct Post-MarketingPlanning
& Initiation
Key R&D Challenges We Hear From Our Customers
attrition
▪ Make rapid, informed
go/no-go decisions
▪ Conduct rapid and
effective audit defense
in-depth data analysis
▪ Comply with regional
and global standards
schedule/resources
▪ Speed setup and
deployment
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Intensifying the Challenges…
Volume Petabytes of structured and unstructured data
Variety AE/SAE, ConMed, genomic, proteomic, EMR…Variety AE/SAE, ConMed, genomic, proteomic, EMR…
Velocity Demand for increasingly rapid data collection and delivery
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Traditional Solutions Are Lagging Behind Shifts in the Industry
Trial ConductPlanning
& InitiationAnalysis &
Submission Post-Marketing
▪ Inability to mine siloed
and historical trial data
▪ High variance in
cost forecasts
▪ Lack of innovation leads
to focus on incremental
efficiency gains
▪ Shallow functionality
▪ Lack of genomic and
biomarker data
▪ Difficulty validating
against real world data
▪ Inability to capture
usable real-world data
▪ Limited ability to analyze
structured and cost forecasts
▪ Inability to predict FTE
demand by schedule
▪ Lack of ability to
validate protocol and
study design
▪ Shallow functionality
beyond EDC core
▪ Lack of real-time
visibility to data
including dosage
▪ Time-intensive efforts to
collect and clean data
against real world data
▪ Inability to track and
trace data for reanalysis
▪ Data sets don’t support
fast, effective risk/benefit
decision-making
structured and
unstructured data
▪ No way to compare
real-world evidence with
other data sources
▪ Limited capture of AEs
in marketed products
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What’s Required: Transform Current Capabilities
Siloed clinical workflow
Cost benchmarking
Targeted SDV
Activity-based planning
Holistic risk-based monitoring
EDC
Trial evidence
Increase drug and device pipeline
Reduce phase II-III attrition
Deliver personalized therapies
Mine trial data for off-target indications
Improve patient safetyGenomics, biomarker and EMR data
End-to-end clinical data management
Integrated end-to-end workflow
Smartphones and tablets
Real-time, actionable dataStatic data
Improve patient safety
Make precise cost and resource forecasts
Reduce trial timelines by months
Reduce trial cost by millions
Conduct fast, effective audit defense
Machine-to-machine data
Laptops and PCs
Manual data entry
Multi-therapeutic trialsSingle-therapy trials
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The Objective: Clinical Research Process Excellence
High Quality of Data“Single source of the truth” for data and standards
Advanced query management
Design libraries and templates following best practices
Real-time visibility into data
Data resides in silos; limited use of standards
Some design best practices
Target Zone
Paper-based processes
Full source data verification
Functional silos
Limited reporting
Mix of electronic and manual processes
Some communication across silos and with CROs
Mostly electronic processes
Some integration and automation of workflow
Integrated, automated, end-to-end data management
Comprehensive reporting and ad hoc reporting
Targeted SDV
High Efficiency
Data Operations
Low Efficiency
Data Operations
Low Quality of Data
Some design best practices
Mix of automation and manual processes
Limited query management
Poor design of edit checks, rules, and discrepancy mgt
Lack of visibility to data
Manual, duplicative data entry
Standards not used—data fragmented
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Risk Based MonitoringRisk Based Monitoring
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Regulatory Guidance� Flexibility to choose optimal
combination of monitoring strategies
� Critical study parameters
� Appropriate use of centralized monitoring and technological advances
� Risk-based approach to quality management
� Systematic, prioritized risk-based approach
� “Targeted use of resources
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Risk-Based Monitoring Methodology by TransCelerate BioPharmaconsortium (a non-profit org focused on advancing innovation in R&D)
%of SDV-generated queries in critical data = 2.5%
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Purpose of Monitoring (from FDA Guidance)Smart monitoring by QbD!!
Focus on:
• Processes that are critical to protecting human subjects
• Maintaining the integrity of study data
The findings should be used to correct investigator and site practices that
could result in inadequate human subject protection and/or poor data
quality.
“What could keep you from including a study in your filing?”
• Compliance with applicable regulations
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Risk-based management technologies must execute three functions well
1. Develop
– Developing an upfront risk assessment that takes into account the critical data
and processes involved in the study
2. Design
– Designing for quality and consistent application of risk assessment practices – Designing for quality and consistent application of risk assessment practices
across the organization
� e.g. people, partners, processes, and investigator sites,
� tracking trial workflow (the clinical systems, protocol design and trial design);
3. Evaluate
– Quickly and easily evaluating the critical data and processes involved in risk
assessment.
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A holistic platform that supports risk based monitoring of clinical trialsThis flexible, cloud-based platform integrates key enabling technologies and has the
flexibility to evolve to meet the changing requirements of clinical trials.
InForm or standards
based EDCbased EDC
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Risk-Based Monitoring by Application
OC/RDC OC/RDC
& InForm or
3rd Party
Applications Presentation
Interactive
OBI-EE
A holistic platform that supports risk based monitoring of clinical trialsThis flexible, cloud-based platform integrates key enabling technologies and has the
flexibility to evolve to meet the changing requirements of clinical trials.
3 Party3rd Party
Ad Hoc Analysis
Proactive Alerts
MS Office Integration
Interactive Dashboards
iPhone / iPad Integration
Clinical Development
Analytics
Argus
Safety
Or 3rd Party Safety
Siebel
Clinical
Or 3rd Party CTMS
Mobile CRA
EmpericaInspections
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Enabling Operational Performance Management from Sites to Execs
ORACLE CLINICAL DEVELOPMENT ANALYTICS
Executive
Team
Head of Clinical
Operations
Organizational
Progress
Departmental /
CRA /
Data Manager
Clinical Sites
Departmental /RegionalProgress
Study Progress
Site Progress
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CRA Overview
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Study Site Milestone
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Risk Based Monitoring in CDASample Study Risk Dashboard
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Tracking Site Performance – Quantitative in CTMS
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EDC platform enables Risk-Based Monitoring
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Mobile Monitoring
•Enable Tablet Only Site Visits • Trip Reporting
• EDC (SDV / Queries) via tablet
• Essential documents
• Contacts / Calendar
Access Anywhere
• Instant access to Site Dashboards
•Configurable KPIsSite-At-A-
Glance•Alerts – For CRAs and Sites
Glance
• Full CTMS site contacts – frequently used and seldom used
• Study, site, patient, and personal calendars
• Synchronize contacts to smartphone or tablet
Easy Collaboration
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Medication adherenceMedication adherence
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Medication Adherence Technology
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eICFeICF
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� Full Signature
eICF technologies
• Podcast
• Embedded comments in ICF
• Videos
• Interactive webpages
For Volunteers For Researchers
� Checkbox
• Interactive webpages
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Fitment of eICF
Online survey studies Patients are asked their activity and pain level 3 months after receiving
composite femoral components for hip arthroplasty
Online screening Potential subjects are asked a series of questions about their health history to
determine eligibility in a study testing a novel drug for Rheumatoid Arthritis.
Since these screening questions do not require an office visit, potential
subjects can be both consented and screened electronically.
Where can it fit ?
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subjects can be both consented and screened electronically.
Submitting Bio Specimens via mail
company conducting genetics research is collecting buccal samples for
analysis
Previously collected tissue research
Cosmetic surgery patients are contacted for their consent to use their
discarded tissue to test a new topical drug for hair growth.
In-person paperless survey research
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Benefits and Challenges of eICF
Benefits for patients Benefits for Researchers Challenges
Convenience Higher Enrollment Expensive
Less pressure and anxiety True Informed Consent Verification
More informed More Compliant Participants Compliance
26
More informed More Compliant Participants Compliance
More engaged Convenience
Paperless
Increased capability
Trust factor
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eSourceeSource
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eSource
Database
28
ase
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eSource and Data Verification
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How much is right ?
The Shuttle Atlantis Cockpit
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Thank YouThank You