1 / 35

Nationwide CCOPD Initiative

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. Presentation plan. Introduction. What are the trends?. Application Portfolio. Solution approach.

kenyon
Download Presentation

Nationwide CCOPD Initiative

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 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

  2. Presentation plan • Introduction • What are the trends? • Application Portfolio • Solution approach • Existing application in COPD • Conclusion and questions period

  3. 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.

  4. 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?

  5. 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

  6. Business Challenge Source: Gartner Dataquest

  7. Application Portfolio Source: Gartner Dataquest

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Preliminary analysis study Define Project Principles Define Technology Principles Principles & Objectives Define Clinical Trial Process Target Define Functionality Requirements Processus & Functionalities Inventory Used Application Inventory Existing Vendor Solution Solution Inventory Write Functional Gap Analysis Recommend Solution Application Selection

  16. 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

  17. 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

  18. Preliminary Analysis Study Define Technology Principles • Define Technology Principles (con’t) • Examples • 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

  19. Preliminary Analysis Study Define Clinical Trial Process Target • Define Clinical Trial Business 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 outfor a specific case?

  20. Preliminary Analysis Study • Example

  21. 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.

  22. Preliminary Analysis Study • Example

  23. Preliminary Analysis Study Inventory Used Application • Inventory Used Application • List of potential applications already used in the organization

  24. Preliminary Analysis Study Inventory Existing Vendor Solution • Inventory Existing Vendor Solution • List of potential applications available onthe market

  25. 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

  26. Preliminary Analysis Study • Example

  27. Existing applications: IRMPOC

  28. Existing applications: IRMPOC v2

  29. Existing applications: IRMPOC v2

  30. Existing applications: COPD-REHAB

  31. Existing applications: COPD-REHAB

  32. 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.

  33. 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.

  34. 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. • …

  35. Questions period ?

More Related