Transcript 2 Steps Path

Nationwide CCOPD Initiative
Clinical Trial
Management System
Yvan Fortier
Biomedical Telematics Laboratory of the RHN (LTB)
with the collaboration of Steve Bélanger
LGS Group inc
© LTB, June 2006
Presentation plan
Introduction
What are the trends?
Application Portfolio
Solution approach
Existing application in COPD
Conclusion and questions period
© LTB, June 2006
Introduction
The Biomedical Telematics Laboratory (LTB)
Created in 1995
Mission statement: To support the RHN’s
investigators in their projects by doing analysis,
developpement and maintenance of computing
solutions.
Located in Sherbrooke University Medical Centre,
Sherbrooke Qc.
© LTB, June 2006
Introduction
What is the situation now?
What is available now?
What should we do since we know that?
How should we do it?
What we learned with precedent trials?
© LTB, June 2006
What are the trends?
Technology-related insight for IT professionals
3,700 associates
650 research analysts
550 consultants in 75 countries worldwide
Source: Gartner.com
© LTB, June 2006
Business Challenge
Business Challenge
Improve the productivity of
data collection and cleansing
Key Business Benefits and
Metrics
Reduction in time associated
with clinical data collection
Reduction of time-todatabase-lock
Improve process
management and reporting
Redeployment of manual
clinical trial personnel to
electronic based activities
Reduction in full time
equivalent personnel
associated with paper based
activities
Reduction in monitoring fulltime equivalent personnel.
Reduction the number of
queries/exceptions associated
with protocol non
conformance
Reduction time of FDA
approval
Improve the discrimination
power of trials
Source: Gartner Dataquest
© LTB, June 2006
Key Technology Benefits
and Metrics
Elimination of paper based
data collection or double
entries
Real time access/data
manipulation capabilities for
study status for relevant
investigators
Provision of real-time flags for
exceptions
Real-time access of clinical
data to study volunteers
Integration of remote webbased data collection
applications
Deployment of systems
compliant with federal
regulations (21 CFR part 11)
Application Portfolio
Source: Gartner Dataquest
© LTB, June 2006
Application Portfolio
Clinical Trial Management
Clinical trial management system (CTMS)
facilitate the planning, scheduling and tracking of relevant
clinical activities,
provides project and financial management functions
An important extension goingforward is a robust
connection to computer-based patient record systems
© LTB, June 2006
Application Portfolio
Clinical Trial Management (con’t)
Some examples of the capabilities typically provided are:
Tracking of monitoring visits and patient visits
Providing the status of approvals required during the trials
Budgeting and tracking of costs and payments
Forecasting trial requirements (such as clinical supplies)
Representative Vendors and Applications
Oracle — Clinical
Perceptive Informatics — Impact (formerly FW Pharma
acquired by PAREXEL)
Phase Forward — Clintrial
Siebel Systems — Clinical
© LTB, June 2006
Application Portfolio
Study definition and design
This category provides support for:
Developing protocol designs, often using simulation tools to test
assumptions in "virtual clinical trials"
Identifying and selecting the investigators to conduct the clinical
trial
Seeking and gaining approval from an institutional review board
Representative vendor and application
Pharsight's Trial Simulator
© LTB, June 2006
Application Portfolio
Document Management
Document management applications organize, manage
and store records generated during trials.
They must provide robust version control, as well as
check in/check out control. Compliance with good
clinical practices and 21 CFR Part 11 is expected.
Representative Vendors and Applications
BM and Documentum — GXPharma
Open Text — Livelink
© LTB, June 2006
Application Portfolio
Electronic information capture
Two types of electronic information capture systems have
gained traction in the clinical trial market
Electronic Data Capture (EDC) applications
Electronic Patient Diaries (EPD) applications
EDC Representative Vendors and Applications
DataLabs — DataLabsXC; etrials — QuickStudy Capture;
Medidata — RAVE; Phase Forward — Inform; TrialStat ; Scian
EPD Representative Vendors and Applications
CRF Box — TrialMax; etrials — QuickStudy Log; invivodata;
PHT — LogPad
© LTB, June 2006
Application Portfolio
Analysis and Reporting
Analysis tools support scientific investigation, business
examination and data mining. They often provide
multimodal presentation capabilities ranging from formal
standardized reports to ad hoc Web-based queries.
Representative Vendors and Applications
SAS Institute — SAS Drug Development
Cognos
MS Excel
MS Access
© LTB, June 2006
Solution Approach
2 Steps
Path
1st step - Preliminary Analysis Study
Define Project Principles
Define Technology Principles
Define Clinical Trial Process Target
Define Functionality requirements
Inventory Already Used Application
Inventory Existing Vendor Solution
Write Functional Gap Analysis
Recommend Solution
2nd step - Package Products and Services
Acquisition
To be done after step 1
© LTB, June 2006
Preliminary analysis study
Define
Technology
Principles
Define Project
Principles
Define Clinical
Trial Process
Target
Inventory
Used
Application
Define
Functionality
Requirements
Inventory
Existing Vendor
Solution
Write Functional
Gap Analysis
© LTB, June 2006
Principles &
Objectives
Recommend
Solution
Processus &
Functionalities
Solution
Inventory
Application
Selection
Preliminary Analysis Study
Define Project Principles
Define Project
Principles
To describe the business objectives, scope, and critical
requirements for the information system.
To describe the users' critical requirements and design
principles for the information system.
To define global quality criteria against which the users
will measure the information system
Examples
Standard conformity (CFR 21, others)
Data Location (Canadian vs US)
Buy or host software package preference
Internet usage / Web application
© LTB, June 2006
Preliminary Analysis Study
Define Technology Principles
Define
Technology
Principles
Principles governing the technology infrastructure
configurations (computers, peripherals, communication
equipment and system software), the communication
protocols, the security implementation, the distribution of
functionality
Interoperability
Security Criteria
Reliability Criteria
• Robustness, detection, correction and recovery from errors.
Efficiency Criteria
• Capacity, response time, activation frequency, resources used.
• Analyzability, changeability, stability, testability.
Maintainability Criteria
Portability Criteria
© LTB, June 2006
Preliminary Analysis Study
Define Technology Principles (con’t)
Examples
Define
Technology
Principles
A configuration consistent with IT strategies.
Turnkey solutions.
Multilevel system security.
Communication standards (e.g., Health Level 7, TCP/IP, DICOM).
Simplified documentation and inputs.
A graphical user interface.
An open systems architecture.
Scalability to meet the CDO's current and potential needs.
The ability to operate in a geographically dispersed environment.
Networking.
Relational database storage.
Broad interfacing.
Flexible report writing.
Standard and programmable reporting.
A Web-enabled design.
A growth path open to future enhancements and technology
© LTB, June 2006
Preliminary Analysis Study
Define Clinical Trial Business
Process Target
Define Clinical
Trial Process
Target
A business process model shows the following design
decisions:
Who are the actors involved in the operations?
Which operational activities can be distinguished?
Which activities are executed by which actors?
What are the inputs and outputs of activities?
What is the sequence of activities to be carried out
for a specific case?
© LTB, June 2006
Preliminary Analysis Study
Example
© LTB, June 2006
Preliminary Analysis Study
Define Functionality Requirements
Define
Functionality
Requirements
To identify the major aspects that a project is looking
for in different products and services.
To identify the functional criteria that will serve as a
basis for selecting products and services.
© LTB, June 2006
Preliminary Analysis Study
Example
© LTB, June 2006
Preliminary Analysis Study
Inventory Used Application
Inventory
Used
Application
List of potential applications already used in the
organization
© LTB, June 2006
Preliminary Analysis Study
Inventory Existing Vendor Solution
List of potential applications available on
the market
© LTB, June 2006
Inventory
Existing Vendor
Solution
Preliminary Analysis Study
Write Functional Gap Analysis
Write Functional
Gap Analysis
To identify the criteria and method for evaluating
suppliers' product.
To produce a comparative assessment of suppliers'
proposals, products, and services.
To provide a basis for product or service selection
To identify the products and services that best
meet the project’s requirements
© LTB, June 2006
Preliminary Analysis Study
Example
© LTB, June 2006
Existing applications: IRMPOC
© LTB, June 2006
Existing applications: IRMPOC v2
© LTB, June 2006
Existing applications: IRMPOC v2
© LTB, June 2006
Existing applications: COPD-REHAB
© LTB, June 2006
Existing applications: COPD-REHAB
© LTB, June 2006
What we learned?
At a user point of view…
it is important to:
inform users on where they are, where they come
from and where they can go in the tools they use;
allow users to navigate smoothly between subjects,
projects or forms;
favorise the usage of combo box instead of radio
buttons in the application;
match as close as possible the design of the computer
based tool if it is use in conjonction with paper forms.
© LTB, June 2006
What we learned?
At a coordination point of view…
it is important to:
minimize the time invested in tracking datas associated
with protocol non conformance by a solid and early
validation of the datas
maximize the usage of preformated combo box instead
of clear text
integrate the concept of missing datas to allow users
to enter datas in multiple sessions.
© LTB, June 2006
What we learned?
At a management point of view…
it is important to:
always keep a full control on the application
developpment and data storage.
…
© LTB, June 2006
Questions period
© LTB, June 2006