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Research & Development ProcessResearch & Development Process

Target Identification

& Prioritization

Drug Discovery Pre-Clinical Clinical

Development

Governance & Risk Management

Regulatory Affairs (incl. FDA, SOX and SPL)

Manufacturing Scale-up

Portfolio and Project Management (incl. Budgeting Process)

Presentation FocusPresentation Focus

Marketing

Today's Challenges in Managing Clinical Trials

Horst Nowak

Director Data Management & Biostatistics

Omega Mediation – Clinical Research Services

Bingen/Offenbach/Athens

Digital Pharma: Effiziente Forschungs- und Entwicklungsprozesse in der Pharma-/Life Science-Industrie

Wiesbaden, November 24, 2005

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Definitions

Clinical Trial Management (CTM)management data (e.g. times, resources, responsibilities, budget),trial meta data (e.g. from protocol, CRF, standards)

Clinical Data Management (CDM)patient data (e.g. from CRF, diaries, electronic devices)

Toolse.g. dictionaries, codelists

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Requirements

Clinical Trial Management (CTM)- project management on study and project level- status reports (availability and distribution of docs, trial progress)- key performance indices (benchmarks)- forecasts for other studies/projects - link to document management system (scanning, imaging)

Clinical Data Management (CDM)- exchange (CROs, license partners, authorities)- establishment of a clean database, incl. validation/query process- availability of valid data for analysis and report- long term availability of data (audits, inspections)- link to document management system (scanning, imaging)

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CDM: Sources for data

pastpast futurefuture

paperpaperdata tablesdata tables

paperpaperCRFCRF

paperpaperdiariesdiaries

CRF: process orientedCRF: process oriented

electronicelectronicdiariesdiaries

electronicelectronicCRF (PC based)CRF (PC based)

electronicelectronicCRF (internet)CRF (internet)

electronicelectronicfile transferfile transfer

electronicelectronicdata uploadingdata uploading

patientspatients

investigatorsinvestigators

labs, deviceslabs, devices

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CDM: Interactions (data flow)

InvestigatorInvestigator Data ManagerData ManagerMonitorMonitor

PatientPatient

DCFDCF (Data Clarification Form) (Data Clarification Form)

CRFCRF

diarydiary

RegulatorRegulator

BiostatisticianBiostatisticianMed. WriterMed. Writer

lab, deviceslab, devices

otherother

AuthorityAuthorityReviewerReviewer

Drug SafetyDrug Safety

SAE formSAE form

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CDM: Cooperations

SponsorSponsor

lab, deviceslab, devices

AuthoritiesAuthorities

CROCROLicense partner(s)License partner(s)

InvestigatorsInvestigators

PatientsPatients

electronicallyelectronicallyvia papervia paper

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CDM and Clinical Operations (COp): new processes

the past- CDM linear to COp: CDM to COp, COp to investigators- CRF development, database design prior to data entry

the future- no need for paper exchange by COp at investigators- need for hot line and technical support- CRF = screen design as part of database design, prior to investigators' training

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Challenges: CTM

hierarchical data condensing real time information (automatic data exchange with CDM) distributed responsibilities: CROs for data delivery multisite access (user roles and rights) tracking of times and budgets focus on key performance indices workflow for defined events portability? validation?

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Challenges: CDM (1)

flexibility for different input data streams linkage to imaged documents (if paper is used) real time information (automatic data exchange with

investigators and labs, e.g. internet) feedback actions, incl. correction request to investigators paper copies (for SDV, for long term documentation) data lock on various levels multisite access (user roles and rights)

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Challenges: CDM (2)

(status) reports in paper and as data exchange to CTM focus on key performance indices workflow for defined events portability (CDISC)! validation!

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Case Study – Microsoft solution @ Merck

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Improved Trial Administration

Business value

Hierarchical overview on all trial related information

Real-time information Distributed roles and

responsibilities for faster results

Direct access to all critical information (costs, enrollement, etc.)

Central administration of role access and security

Direct links to team members

Dashboard allows overview on trial status at-a-glance

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Improved Trial Administration

Business Value

Fast, cost effective training via the participants’ laptops

Training contents can be modularized to allow faster completion

Improved user acceptance Consistent training of all

study team members ensures conformity in study conduct

Improved feedback on training needs and performance

Certification and compliance

Interactive Training modules

Training can be run real-time or archived for self study

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Standardized Data Collection Processes

Business Value Reduced error rate

and high acceptance by guiding users through data entry

Templates based on standards including all FDA relevant fields

Faster CRF generation by distributed authoring processHighly intuitive

design using graphical elements

CRF pages can only modified by authorized users

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More Effective Data Management

Business Value

Real time tracking of patients during the study avoids over-recruitment

Reduced error rates and rapid closure of queries

Rapid freezing of patient data

Real tiome status of all patients in the study

Fast overview on study progress from different perspectives

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Integration: CTM & CDM

CTMCTM CDMCDM

company IT environmentcompany IT environment

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Conclusions and Critics

Establishing modern CTM&CDM needs not only IT decision, but a re-organisation of many processes (across departments).

Modern CTM&CDM solutions will speed up the availability of information for decision. It is in question how far this improvement will also speed up the entire development as there are many externally driven process steps. Shortening the number of trials is more efficient than looking into each trial into details.

Independently from theoretically possible solutions, it must be decided whether an entire electronic solution is desirable. A paper backbone may be favourable with respect to FDA "21 CFR part 11" requirements.

Full electronic solutions in the long-term development of drugs impose the problem of system and release changes.

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Many thanks for your attention!Questions to:

Dr. Horst NowakDirector, Data Management & Biostatistics

Omega Mediation Clinical Research Services GmbH & Co. KGKaiserleistr. 2963067 Offenbach am Main Tel.: +49-69-8509 338-12Fax: +49-69-8509 338-18

www.omega-mediation.com

Ruediger DornDirector Process Manufacturing IndustriesEurope Middle East & AfricaMicrosoft Deutschland GmbH Tel.       +49 (0)89 3176 3780  Fax       +49 (0)89 3176 1000Cell      +49 (0)175 5844 012Mail      rdorn@microsoft.com