© ltb, june 2006 nationwide ccopd initiative clinical trial management system yvan fortier...

© LTB, June 2006

Nationwide CCOPD InitiativeNationwide CCOPD Initiative

Clinical TrialClinical TrialManagement SystemManagement System

Yvan FortierYvan Fortier

Biomedical Telematics Laboratory of the RHN (LTB)Biomedical Telematics Laboratory of the RHN (LTB)

with the collaboration of Steve Bélangerwith the collaboration of Steve Bélanger

LGS Group incLGS Group inc

© LTB, June 2006

Presentation planPresentation plan

IntroductionIntroduction

What are the trends?What are the trends?

Application PortfolioApplication Portfolio

Solution approachSolution approach

Existing application in COPDExisting application in COPD

Conclusion and questions periodConclusion and questions period

© LTB, June 2006


The Biomedical Telematics Laboratory The Biomedical Telematics Laboratory (LTB)(LTB)

Created in 1995Created in 1995

Mission statement: To support the RHN’s Mission statement: To support the RHN’s investigators in their projects by doing investigators in their projects by doing analysis, developpement and maintenance of analysis, developpement and maintenance of computing solutions.computing solutions.

Located in Sherbrooke University Medical Located in Sherbrooke University Medical Centre, Sherbrooke Qc. Centre, Sherbrooke Qc.

© LTB, June 2006


What is the situation now?What is the situation now?

What is available now?What is available now?

What should we do since we know that?What should we do since we know that?

How should we do it?How should we do it?

What we learned with precedent trials?What we learned with precedent trials?

© LTB, June 2006

What are the trends?What are the trends?

Source: Gartner.com

Technology-related insight for IT Technology-related insight for IT professionalsprofessionals

3,700 associates3,700 associates

650 research analysts 650 research analysts

550 consultants in 75 countries worldwide550 consultants in 75 countries worldwide

© LTB, June 2006

Business ChallengeBusiness ChallengeBusiness Challenge Key Business Benefits and

Metrics Key Technology Benefits

and Metrics Improve the productivity of data collection and cleansing

Reduction in time associated with clinical data collection

Elimination of paper based data collection or double entries

Reduction of time-to-database-lock

Real time access/data manipulation capabilities for study status for relevant investigators

Redeployment of manual clinical trial personnel to electronic based activities

Reduction in full time equivalent personnel associated with paper based activities

Reduction in monitoring full-time equivalent personnel.

Provision of real-time flags for exceptions

Improve process management and reporting

Reduction the number of queries/exceptions associated with protocol non conformance

Real-time access of clinical data to study volunteers

Reduction time of FDA approval

Integration of remote web-based data collection applications

Improve the discrimination power of trials

Deployment of systems compliant with federal regulations (21 CFR part 11)

Source: Gartner Dataquest

© LTB, June 2006


Source: Gartner Dataquest

© LTB, June 2006


Clinical Trial ManagementClinical Trial ManagementClinical trial management system (CTMS) Clinical trial management system (CTMS)

facilitate the planning, scheduling and tracking of facilitate the planning, scheduling and tracking of relevant clinical activities,relevant clinical activities,

provides project and financial management functionsprovides project and financial management functions

An important extension goingforward is a robust An important extension goingforward is a robust connection to computer-based patient record connection to computer-based patient record systemssystems

© LTB, June 2006

Clinical Trial ManagementClinical Trial Management (con’t) (con’t)Some examples of the capabilities typically provided Some examples of the capabilities typically provided are:are:

Tracking of monitoring visits and patient visitsTracking of monitoring visits and patient visits

Providing the status of approvals required during the trialsProviding the status of approvals required during the trials

Budgeting and tracking of costs and paymentsBudgeting and tracking of costs and payments

Forecasting trial requirements (such as clinical supplies)Forecasting trial requirements (such as clinical supplies)


Representative Vendors and Applications Representative Vendors and Applications Oracle — ClinicalOracle — Clinical

Perceptive Informatics — Impact (formerly FW Pharma Perceptive Informatics — Impact (formerly FW Pharma acquired by PAREXEL)acquired by PAREXEL)

Phase Forward — ClintrialPhase Forward — Clintrial

Siebel Systems — ClinicalSiebel Systems — Clinical

© LTB, June 2006

Study definition and designStudy definition and designThis category provides support for:This category provides support for:

Developing protocol designs, often using simulation tools Developing protocol designs, often using simulation tools to test assumptions in "virtual clinical trials"to test assumptions in "virtual clinical trials"

Identifying and selecting the investigators to conduct the Identifying and selecting the investigators to conduct the clinical trialclinical trial

Seeking and gaining approval from an institutional Seeking and gaining approval from an institutional review boardreview board


Representative vendor and applicationRepresentative vendor and applicationPharsight's Trial SimulatorPharsight's Trial Simulator

© LTB, June 2006

Document ManagementDocument ManagementDocument management applications organize, Document management applications organize, manage and store records generated during trials.manage and store records generated during trials.

They must provide robust version control, as well as They must provide robust version control, as well as check in/check out control. Compliance with good check in/check out control. Compliance with good clinical practices and 21 CFR Part 11 is expected.clinical practices and 21 CFR Part 11 is expected.


Representative Vendors and ApplicationsRepresentative Vendors and ApplicationsBM and Documentum — GXPharmaBM and Documentum — GXPharma

Open Text — Open Text — LivelinkLivelink

© LTB, June 2006

Electronic information captureElectronic information captureTwo types of electronic information capture systems Two types of electronic information capture systems have gained traction in the clinical trial markethave gained traction in the clinical trial market

Electronic Data Capture (EDC) applicationsElectronic Data Capture (EDC) applications

Electronic Patient Diaries (EPD) applicationsElectronic Patient Diaries (EPD) applications


EDC Representative Vendors and ApplicationsEDC Representative Vendors and ApplicationsDataLabs — DataLabs — DataLabsXCDataLabsXC; ; etrials — QuickStudy Capture; etrials — QuickStudy Capture; Medidata — RAVE; Phase Forward — Inform; TrialStat ; ScianMedidata — RAVE; Phase Forward — Inform; TrialStat ; Scian

EPD Representative Vendors and ApplicationsEPD Representative Vendors and ApplicationsCRF Box —CRF Box — TrialMax TrialMax; ; etrials — QuickStudy Log; etrials — QuickStudy Log; invivodata; invivodata; PHT — LogPadPHT — LogPad

© LTB, June 2006


Analysis and ReportingAnalysis and ReportingAnalysis tools support scientific investigation, Analysis tools support scientific investigation, business examination and data mining. They business examination and data mining. They often provide multimodal presentation often provide multimodal presentation capabilities ranging from formal standardized capabilities ranging from formal standardized reports to ad hoc Web-based queries.reports to ad hoc Web-based queries.

Representative Vendors and ApplicationsRepresentative Vendors and ApplicationsSAS Institute — SAS Drug DevelopmentSAS Institute — SAS Drug Development

CognosCognos

MS ExcelMS Excel

MS AccessMS Access

© LTB, June 2006

Solution ApproachSolution Approach

1st step - Preliminary Analysis Study1st step - Preliminary Analysis StudyDefine Project PrinciplesDefine Project PrinciplesDefine Technology PrinciplesDefine Technology PrinciplesDefine Clinical Trial Process TargetDefine Clinical Trial Process TargetDefine Functionality requirementsDefine Functionality requirementsInventory Already Used ApplicationInventory Already Used ApplicationInventory Existing Vendor SolutionInventory Existing Vendor SolutionWrite Functional Gap AnalysisWrite Functional Gap AnalysisRecommend SolutionRecommend Solution

2 StepsPath

2nd step - Package Products and 2nd step - Package Products and Services AcquisitionServices Acquisition

To be done after step 1To be done after step 1

© LTB, June 2006

Preliminary analysis studyPreliminary analysis study

Define ProjectPrinciples

DefineTechnologyPrinciples

Define Clinical Trial Process

Target

Inventory Used

Application

InventoryExisting Vendor

Solution

Write Functional Gap Analysis

RecommendSolution

DefineFunctionalityRequirements

Principles &Principles &ObjectivesObjectives

Processus &Processus &FunctionalitiesFunctionalities

SolutionSolutionInventoryInventory

ApplicationApplicationSelectionSelection

© LTB, June 2006

Define Project PrinciplesDefine Project PrinciplesTo describe the business objectives, scope, and To describe the business objectives, scope, and critical requirements for the information system.critical requirements for the information system.

To describe the users' critical requirements and To describe the users' critical requirements and design principles for the information system.design principles for the information system.

To define global quality criteria against which To define global quality criteria against which the users will measure the information systemthe users will measure the information system

Define ProjectPrinciples

Preliminary Analysis StudyPreliminary Analysis Study

ExamplesExamplesStandard conformity (CFR 21, others)Standard conformity (CFR 21, others)Data Location (Canadian vs US)Data Location (Canadian vs US)Buy or host software package preferenceBuy or host software package preferenceInternet usage / Web applicationInternet usage / Web application

© LTB, June 2006

Define Technology PrinciplesDefine Technology PrinciplesPrinciples governing the technology infrastructure Principles governing the technology infrastructure configurations (computers, peripherals, configurations (computers, peripherals, communication equipment and system software), communication equipment and system software), the communication protocols, the security the communication protocols, the security implementation, the distribution of functionalityimplementation, the distribution of functionality

InteroperabilityInteroperabilitySecurity CriteriaSecurity CriteriaReliability CriteriaReliability Criteria

• Robustness, detection, correction and recovery from errors.Robustness, detection, correction and recovery from errors.

Efficiency CriteriaEfficiency Criteria• Capacity, response time, activation frequency, resources Capacity, response time, activation frequency, resources

used.used.• Analyzability, changeability, stability, testability.Analyzability, changeability, stability, testability.

Maintainability CriteriaMaintainability CriteriaPortability CriteriaPortability Criteria



© LTB, June 2006

Define Technology Principles (con’t)Define Technology Principles (con’t)ExamplesExamples

A configuration consistent with IT strategies.A configuration consistent with IT strategies.Turnkey solutions.Turnkey solutions.Multilevel system security.Multilevel system security.Communication standards (e.g., Health Level 7, TCP/IP, DICOM).Communication standards (e.g., Health Level 7, TCP/IP, DICOM).Simplified documentation and inputs.Simplified documentation and inputs.A graphical user interface.A graphical user interface.An open systems architecture.An open systems architecture.Scalability to meet the CDO's current and potential needs.Scalability to meet the CDO's current and potential needs.The ability to operate in a geographically dispersed The ability to operate in a geographically dispersed environment.environment.Networking.Networking.Relational database storage.Relational database storage.Broad interfacing.Broad interfacing.Flexible report writing.Flexible report writing.Standard and programmable reporting.Standard and programmable reporting.A Web-enabled design.A Web-enabled design.A growth path open to future enhancements and technologyA growth path open to future enhancements and technology



© LTB, June 2006

Define Clinical Trial Business Define Clinical Trial Business Process TargetProcess Target

A business process model shows the following A business process model shows the following design decisions:design decisions:

Who are the actors involved in the operations?Who are the actors involved in the operations?

Which operational activities can be distinguished?Which operational activities can be distinguished?

Which activities are executed by which actors?Which activities are executed by which actors?

What are the inputs and outputs of activities?What are the inputs and outputs of activities?

What is the sequence of activities to be carried outWhat is the sequence of activities to be carried out

for a specific case?for a specific case?

Define Clinical Trial Process

Target


© LTB, June 2006


ExampleExample

© LTB, June 2006

Define Functionality RequirementsDefine Functionality RequirementsTo identify the major aspects that a project is To identify the major aspects that a project is looking for in different products and services.looking for in different products and services.

To identify the functional criteria that will serve To identify the functional criteria that will serve as a basis for selecting products and services.as a basis for selecting products and services.

Preliminary Analysis StudyPreliminary Analysis StudyDefine

FunctionalityRequirements

© LTB, June 2006


ExampleExample

© LTB, June 2006

Inventory Used ApplicationInventory Used Application

List of potential applications already used in the List of potential applications already used in the organizationorganization

Preliminary Analysis StudyPreliminary Analysis StudyInventory

Used Application

© LTB, June 2006

Inventory Existing Vendor SolutionInventory Existing Vendor Solution

List of potential applications available onList of potential applications available onthe marketthe market

Preliminary Analysis StudyPreliminary Analysis StudyInventory

Existing Vendor Solution

© LTB, June 2006

Write Functional Gap AnalysisWrite Functional Gap Analysis

To identify the criteria and method for To identify the criteria and method for evaluating suppliers' product.evaluating suppliers' product.

To produce a comparative assessment of To produce a comparative assessment of suppliers' proposals, products, and services.suppliers' proposals, products, and services.

To provide a basis for product or service To provide a basis for product or service selectionselection

To identify the products and services that best To identify the products and services that best meet the project’s requirementsmeet the project’s requirements

Preliminary Analysis StudyPreliminary Analysis StudyWrite Functional

Gap Analysis

© LTB, June 2006

At a user point of view…At a user point of view…it is important to:it is important to:

inform users on where they are, where they inform users on where they are, where they come from and where they can go in the tools come from and where they can go in the tools they use;they use;

allow users to navigate smoothly between allow users to navigate smoothly between subjects, projects or forms;subjects, projects or forms;

favorise the usage of combo box instead of favorise the usage of combo box instead of radio buttons in the application;radio buttons in the application;

match as close as possible the design of the match as close as possible the design of the computer based tool if it is use computer based tool if it is use in conjonction in conjonction with paper formswith paper forms..

What we learned?What we learned?

© LTB, June 2006

At a coordination point of view…At a coordination point of view…it is important to:it is important to:

minimize the time invested in tracking datas minimize the time invested in tracking datas associated with protocol non conformance by a associated with protocol non conformance by a solid and early validation of the datassolid and early validation of the datas

maximize the usage of preformated combo box maximize the usage of preformated combo box instead of clear text instead of clear text

integrate the concept of missing datas to allow integrate the concept of missing datas to allow users to enter datas in multiple sessions.users to enter datas in multiple sessions.


© LTB, June 2006

At a management point of view…At a management point of view…it is important to:it is important to:

always keep a full control on the application always keep a full control on the application developpment and data storage.developpment and data storage.

……


© ltb, june 2006 nationwide ccopd initiative clinical trial management system yvan fortier...

Documents

rhn ltb

clinical trial management

application portfolio

virtual clinical trials

gartner dataquest slide

questions period slide

good clinical practices

trial requirements