An integrated approach to successful eClinical trials

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An integrated approach to successful eClinical
trials CCRA Seminar Standards in Electronic
Data Capture London 1 November 2005
Dr Bill Byrom Product Strategy Director,
ClinPhone Group Ltd.
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Presentation contents

• Common application of IVR/IWR in todays clinical
  trials
• Why integrate EDC and IVR?
• Integration overview
• Case study Procter Gamble Pharmaceuticals
• Demonstration movie
• Conclusions

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Common IVR / IWR application

• Typical application areas in todays clinical
  trials

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IVR/IWR application

• Secure telephone / web access for the performance
  of various site-based, sponsor-based, or
  patient-based activities.
• Randomization
• Emergency Code Break
• Medication Dispensing and Supply Chain Management
• Electronic Patient-Reported Outcomes (ePRO)
• Patient Pre-qualification and Recruitment

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Recent SurveyClinPhone webinar April 2005 (n300)
What is the largest issue or challenge you face
with randomisation and blinding in todays
clinical trials?

• Ensuring sites follow the randomization process
  correctly
• Preventing tampering of code break envelopes
• Providing 24h on-call code break staff
• Managing more complicated randomization e.g..
  stratification
• Ensuring randomization methods are followed in
  open label studies
• Demonstrating internal staff are blinded to
  randomization schedule
• Other

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Recent SurveyClinPhone webinar April 2005 (n300)
What is the largest issue or challenge you face
with medication management in todays clinical
trials?

• Accurately forecasting the amount of drug
  required
• Managing the logistics of large multinational
  trials
• Managing drug
  expiration
• Limitations on supplies due to manufacturing
• Efficient use of medication in titration studies
• Other

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Medication labelling/dispensingIVR / IWR approach

• Unique Medication Numbering
• Can be applied to Kit of supplies
• Can be applied to the Individual Dispensing Unit
• Any unit can go to any patient(randomised to
  same treatment group)
• Any unit can be used for any treatment period
• Using the smallest dispensing unit gives the most
  flexibility
• Pooling medication across studies possible

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Medication dispensing and re-supply
Notification Arrival / Damaged packs
Dispensing call
Consignment details
Consignment request
Pack numbers
Shipment
A
B
Stock levels fall to trigger level
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Why Integrate?

• The benefits of eClinical integration

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eClinical solutions
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Why Integrate?

• Remove duplication of data and activities
• Ensure all systems contain the most up-to-date
  information at all times
• Simplify processes for the end-user
• Enhanced data access
• Facilitate reporting and consolidation of project
  management data through the solution of choice
• Eliminate manual processes

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Integration principles

• The main objectives of any integrations
• Do each task once remove resource duplication
  and the errors introduced by transcription
• Do it in the place that makes sense decide on
  the best overall process and configure systems to
  fit
• Study specific

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The breadth of integrationExample 1 patient
enrolment
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The breadth of integrationExample 2 IVR diary
call
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Common overlap of data
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Integration overview

• How real-time eClinical integration is achieved
  at ClinPhone

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Data interchange overview
Transformer
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IVR-CTMS Integration
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Integration touchpoints CTMS
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IVREDC integration
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Integration Touchpoints EDC
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Case studyIVR-EDC integration

• Procter and Gamble Pharmaceuticals

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PGPs Best Practices entry
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Case study overview

• Two almost identical study protocols
• IDDM and NIDDM
• Sites
• USA only
• 17 sites
• Patients
• 180 across both studies
• IVR application (ClinPhone)
• Real-time activities whilst with patient
• Randomisation
• Medication dispensing
• Medication supply chain management
• Patient reported outcomes data collection (am and
  pm diary)
• EDC application (Phase Forwards InForm)

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Integration objective 1

• Manage 6 common data points between systems
• Patient demographic information
• Date of birth
• Initials
• Gender
• IVR generated data
• Randomisation number
• Randomisation date
• Randomisation time

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Integration objective 2

• Remove duplication in end-user activities
• Following randomisation call via IVR
• Pass data to InForm
• Enrol an new subject within InForm
• Populate screening and randomisation eCRFs with
  IVR delivered data

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Integration objective 3

• Populate eCRFs with patient diary data in
  real-time
• AM fasting blood glucose reading
• PM sum of three daily dosing insulin volumes
• Eliminate site data entry of paper diary data
• Satisfy regulatory requirements for Investigators
  to take responsibility for diary data
• Monitor diary compliance in real-time
• Review and report diary data alongside other
  clinical data

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PGP key benefits realised

• Site coordinators have less data entry to perform
• The PGP data management group do not have to
  check for discrepancies between common data
  points in the IVR and EDC systems
• Queries from discrepancies are eliminated
• Time and financial benefit for Sponsor and site
  staff
• Patient diary compliance proactively monitored
• Investigators have immediate access to diary data
  via EDC
• Regulatory requirements
• Improvements in patient care and monitoring
• More efficient workflow
• May improve database lock time

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Demonstration movie

• EDC - IVR integration

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Integration example

• Screening data entered within EDC application
• Randomization performed using IWR
• Data received by EDC
• Patient diary event sent from IVR / IWR to EDC

Play movie
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Summary and conclusions
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The Future of Clinical Trials

• A multitude of eClinical technologies are in use
  today
• All are being used in some trials
• Some are tightly integrated with others
• Others still used in isolation
• Integration can provide powerful Sponsor and site
  end-user benefits
• eClinical Trials of the future?
• Evolution not Revolution
• Increased adoption will lead to increased
  requirement to integrate
• Highly integrated seamless solutions

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New study site details Site contact detail
amendments Regulatory / ethics approval
IVR central hub of real-time data
Clinical Trial Management System
Clinical Trial Management System
New patient enrolled / withdrawn/ completed Site
medication inventories Patient tracking data
New study site
Patient withdrawal Patient completion Randomizatio
n data Dose adjustment / calculation data
Electronic Data Capture System
Electronic Data Capture System
Medication pack dispensed
New patient enrolled New study site
Randomization number Medication pack
number(s) IVR diary data
Dispatch notification Pack list and pack list
updates Expiry date updates
New patient enrolled
Drug Supply Chain Management System
New study site / details
Shipment requests
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For more information

• www.clinphone.com
• info_at_clinphone.com