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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. Presentation contents. Common application of IVR/IWR in today’s clinical 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.


Presentation contents
Presentation contents

  • Common application of IVR/IWR in today’s clinical trials

  • Why integrate EDC and IVR?

  • Integration overview

  • Case study: Procter & Gamble Pharmaceuticals

  • Demonstration movie

  • Conclusions


Common ivr iwr application

Common IVR / IWR application

Typical application areas in today’s clinical trials


Ivr iwr application
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


Recent survey clinphone webinar april 2005 n 300
Recent SurveyClinPhone webinar April 2005 (n=300)

What is the largest issue or challenge you face with randomisation and blinding in today’s 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


Recent survey clinphone webinar april 2005 n 3001
Recent SurveyClinPhone webinar April 2005 (n=300)

What is the largest issue or challenge you face with medication management in today’s 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


Medication labelling dispensing ivr iwr approach
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


Medication dispensing and re supply

Investigational site

ClinPhone Inventory

database

Drug distribution

depot

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


Why integrate

Why Integrate?

The benefits of eClinical integration


Eclinical solutions

CTMS

Safety

System

DSMS

IVR

CDMS

EDC

eClinical solutions


Why integrate1
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


Integration principles
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


The breadth of integration example 1 patient enrolment

CTMS

Patient Identifiers, demography and visit frequency data

Drug supply / re-supply request

Safety

System

DSMS

IVR

Randomisation Event

Data for randomisation (eg. stratification variables)

Randomisation and Pack Number

CDMS

Drug Shipment

Patient Data

EDC

Patient Enrolment

The breadth of integrationExample 1: patient enrolment


The breadth of integration example 2 ivr diary call

CTMS

Tracking Primary Efficacy data

Safety

System

Drug re-supply request

DSMS

IVR

Safety alerts

Data validation

Diary Data

CDMS

Patient completes IVR Diary

EDC

Diary Data

Data validation

The breadth of integrationExample 2: IVR diary call


Common overlap of data

ePRO

Randomization

Dispensing

Site contact details

Screening data

IVR

CTMS

EDC

Common overlap of data


Integration overview

Integration overview

How real-time eClinical integration is achieved at ClinPhone


FTP

site

Application-specific message

format

XML message

Event

Exporter

IVR / IWR

database

Application

database

F I R E W A L L

F I R E W A L L

Importer

XML message

Database update

Application-specific

Message

format

FTP

site

Application

Data interchange overview

Transformer


Ivr ctms integration

CTMS

Safety

System

DSMS

IVR

CDMS

EDC

IVR-CTMS Integration


Integration touchpoints ctms

Ethics approval

Regulatory approval

Site details

Delivery addresses

Patient number ranges

Site initiation / qualification

Study timeline

IVR / IWR

CTMS

Site activation

FSFV (screening)

Patient tracking data

Patient tracking data

Patient tracking data

Patient tracking data

Date first drug shipped

Patient tracking data

Randomisation

Re-dispensing

Withdrawal / completion

LSLV

Site de-activation

Site / study close

Integration touchpoints: CTMS


Ivr edc integration

CTMS

Safety

System

DSMS

IVR

CDMS

EDC

IVR–EDC integration


Integration touchpoints edc

Subject no.

Initials / d.o.b.

Stratification data

Site initiation / qualification

Study timeline

IVR / IWR

EDC

Site activation

FPFV (screening)

Initial shipment?

Pack dispensed

Randomization

Re-dispensing

Pack dispensed

Diary data

Withdrawal / completion

LPLV

Withdrawal

Site / study close

Integration Touchpoints: EDC


Case study ivr edc integration

Case studyIVR-EDC integration

Procter and Gamble Pharmaceuticals



Case study overview
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 Forward’s InForm)


Integration objective 1
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


Integration objective 2
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


Integration objective 3
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


P gp key benefits realised
P&GP key benefits realised

  • Site coordinators have less data entry to perform

  • The P&GP 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


Demonstration movie

Demonstration movie

EDC - IVR integration


Integration example
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



The future of clinical trials
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


EDC

IVR/web

IVR/web

IVR/web

CTMS

IVR /

web

CTMS

DSMS

EDC

DSMS

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

Randomization 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


For more information

For more information

www.clinphone.com

[email protected]


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