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The caBIG Strategic Plan

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The caBIG Strategic Plan Powered By Docstoc
					 CTMS November 2006 Face-to-Face
        Welcome and Progress


              November 27, 2006




Meg Gronvall
John Speakman
Christo Andonyadis
Agenda

• Welcome and Introductions
• CTMS Progress
   – Where Have We Been And Where Do We Think We’re
     Going?
   – Progress since July 2006
• CTMS Program Management
• CTMS Strategic Next Steps




                                                      2
Agenda

• Welcome and Introductions
• CTMS Progress
  – Where Have We Been And Where Do We Think We’re
    Going?
  – Progress since July 2006
• CTMS Program Management
• CTMS Strategic Next Steps




                                                     3
CTMS Core Team

• NCICB
   – John Speakman, Associate Director, Clinical Trials
     Products and Programs; Workspace Lead
   – Christo Andonyadis, Associate Director, Clinical Trials
     Application Engineering

• BAH
   – Meg Gronvall, Workspace Lead
   – Charlie Mead, Technical Lead
   – Julie Holtzople, Delivery Management




                                                               4
Agenda

• Welcome and Introductions
• CTMS Progress
  – Where Have We Been And Where Do We Think We’re
    Going?
  – Progress since July 2006
• CTMS Program Management
• CTMS Strategic Next Steps




                                                     5
 What John has learned since moving to NCICB

• For every conference call caBIG™
  has, we have three
• The reason that things sometimes
  move very slowly isn’t that there’s a
  conspiracy to hide stuff - in fact the
  opposite is true
• So… if you feel that there’s something
  in CTMS that hasn’t been
  communicated to you, or something
  doesn’t sound right, don’t just
  complain to each other, let us know!


                                               6
John Speakman, NCICB

• E-mail:
  john.speakman@nih.gov
• Cell phone:
  301 256 7342
• Office:
  301 451 8786
                          7
    Clinical Trials Management Workspace
    Goals, Circa 2004
•   Improve clinical research productivity
•   Integrate the clinical trials infrastructure with the research
    infrastructure
•   Allow sharing of de-identified data across trials and sites
•   Facilitate greater standardization of coding, vocabulary,
    nomenclature and data collection methods as part of clinical trials
•   Define specifications to be followed by developers of new or
    existing clinical trials systems intended to be compatible with caBIG
•   Consistency with NIH Roadmap direction

                                      caBIG – Applications Overview, S. Dubman, February 19, 2004



                                                                                               8
Our Delivery Challenge

                           Nixon’s “War on
                           Cancer” and the
                      Clinton-era doubling of
                     the NIH budget enabled
                           us to figure out
                       “How Cancer Works”
                        (Lauren Sompayrac)
                      but we cannot deliver
                         the full fruits of this
                      knowledge to patients

                                               9
      Enabling Translational Research

                             Translational
                             Research
Information




                   Understanding of Cancer




                              Management of Cancer Patients
                   Time         (from Robert C. Bast, Jr., MD)

                                                                 10
     February 2004 CTMS Prioritization
•   List of Community Needs
1. CDUS/CTMS reporting
2. Adverse event reporting
3. Laboratory interface module
4. Financial and billing system
5. Reporting to the FDA, IND Holder, and hospitals
6. Automatic grading of toxicities for CTC
7. Support multiple destination formats for reporting
8. Protocol management
9. Data conversion tools
10.Patient eligibility filtering and tracking
11.Patient matching to clinical trials
12.Systematic lay summaries
13.Investigator registry
14.Outcomes assessment
15.Participant registry
16.Summary 4 reporting

                                                        11
Current CTMS SIGs
 CTMS WS


                                  Routine Data      Financial Billing
                                   Exchange                                Structured
               Study Calendar                                               Protocol
                                                                         Representation



    Adverse Event
                                                                                      Laboratory
      Reporting                                                                       Interfaces

                                CTMS Steering Committee
     Investigator
         And
         Site                                                                   Best Practices
    Credentialing

                         CRF
                    Standardization                           Clinical Trials
                                          Systems               Database
                                            I/H




                                                                                                   12
   CTMS Vision Statement (May 5, 2004)
“…develop a comprehensive set of modular, interoperable and
standards based tools designed to meet the diverse clinical trials
management needs of the Cancer Center community. The tools
developed will be configurable to meet the needs of Cancer Centers
with little or no clinical data management systems in place as well as
those with robust systems, and will take into account the diversity of
clinical research activities and local practices that exist among these
Cancer Centers. The caBIG core principles of open source, open
access, open development and federation of data sources will guide
all new tool and product development. In particular for this Workspace,
interoperability and modular development are key, as solutions are
likely to consist of a flexible assembly of compatible tools pulled from a
rich collection of tools developed by the Workspace, as well as
existing commercial and locally developed solutions that have been
made caBIG compatible by the community.”


                                                                             13
    Current Vision (up for discussion)

• Supporting a Broader Community
   – Cooperative Groups, SPOREs, CCOPs, Cancer Centers
   – Investigators, Data Managers, Statisticians
• An End-to-end Data Pipeline
   – From Point-of-care Systems (Clinical and Scientific) through
     sponsor submission to regulatory submission
• A Modular Architecture
   – Enabling rapid technological adaptation to new science
• Data Sharing Without Manual Intervention
   – Common Data Elements
   – Common APIs
   – Robust yet flexible security system

                                                                    14
      “End-to-End”
•   Inputs:
     – caXchange (aka the Lab Hub) is a model for a flexible infrastructure that
        will allow any data source (clinical or otherwise) to supply clinical trials
        with data (e.g., surgery, pathology, imaging, gene expression)
•   Outputs:
     – To enable new science through
        data mining
     – To simplify submissions to sponsors
        (e.g., NCI, pharmaceutical
        companies, others)
     – To streamline regulatory
        submission by sponsors (e.g.,
        from pharmaceutical companies
        to the FDA)




                                                                                       15
    Adventures in Regulatory Submission

Problems
• Time-intensive, paper-intensive, labor-intensive regulatory
   submission process
• Not just an FDA/pharma problem: This is slowing the delivery of
   innovative therapies to patients
Approach: Inter-Agency Operational Task Force (IOTF)
Solution: CRIX (Clinical Research Information eXchange)
• Facilitate adoption of electronic data standards, standardized
   terminologies, and electronic submissions
• Reduce the cost of information gathering,
   submissions and analysis / review
• Allow secure transmission/sharing of clinical
   research data

                                                                    16
    FIREBIRD

• Automates/centralizes investigator registration and accreditation
  process (currently uses FDA Form 1572 – cumbersome, repetitive)
• Enables investigators
  to register online
• Digital signature
  technology
• Now in operational
  pilot with NCI, FDA,
  selected medical
  centers/investigators
  and selected
  pharma companies


                                                                      17
     “Modular”
• NCI does not want to prescribe a single clinical trials software
  solution
• NCI does want to foster an infrastructure where everyone can take
  advantage of caBIG™-developed software modules
   – whether they buy, build, obtain
     an open source solution, etc.
• NCI especially wants to
  foster an infrastructure
  where computable, semantically
  interoperable data are easily shared
• NCI proposes a modular
  infrastructure to support
  cancer clinical trials as they
  adapt to changing science
                                                                      18
    Getting There From Here

• Modular and interoperable is not how it works currently
  at Cancer Centers and Cooperative Groups
   – Selecting a CTMS is an enterprise-level decision
• NCI’s job is to identify and build a long-term
  architecture that will support the
  changing needs of science
   – If you’re buying or building, we’d like to
     work with you and/or your vendor
• Modular and interoperable is also not
  how it works currently within the NCI
   – We expect CTWG to be a driving force


                                                            19
 CTMS: We have built a community

• Our immediate challenge is to extend the CTMS
  community to
  include more
  “trialists”:
   – Investigators
   – Community
     Oncologists
   – Data
     Managers
   – Statisticians




                                                  20
Agenda

• Welcome and Introductions
• CTMS Progress
  – Where Have We Been And Where Do We Think We’re
    Going?
  – Progress since July 2006
• CTMS Program Management
• CTMS Strategic Next Steps




                                                     21
     Clinical Trials Management Workspace,
     Circa July 2006
• RFPs
   – Patient Study Calendar (Awarded & under development)
   – Lab Hub Interface (Awarded & under development)
   – Protocol Lifecycle Management (Under Evaluation)
• caAERS Release 1 Prototype: submitted and approved
• 7 Cancer Centers utilizing C3D infrastructure (Including 2 C3PR adopters)
• BRIDG Model:
   – Used as modeling foundation for all CTMS development projects
   – Adding the dynamic aspect (Best Practices/SOPs)




                                                                       22
    Clinical Trials Management Workspace,
    Circa July 2006 (continued)
• Clinical Trial Reporting:
   – CDS Pilot testing for Analysis and Reporting module and Protocol
      Abstraction
• Financial Billing
• Standard Operating Procedures: 18 Published SOPs, 8 awaiting approval
• CTWG
   – Clinical Trials Data Base (CTDB) project: Launched
   – Systems Interoperability & Harmonization (SIH) project: Launched
   – Study Initiation Tool (SIT) Project: Launched
   – Case Report Forms (CRF) project: Launched
   – Investigator & Site Credentialing (ISC) project: Planned launch in
      August 2006
• Expanded the Workspace from 7 SIGs to 11 SIGs


                                                                   23
caBIG™ CTMS Critical Path - 2006
        Other
        Input
                             Patient
                             Registry
                             (C3PR)

        Lifecycle
                                 HL7                    Adverse
       Management                                                 ICSR
                                  v3                     Events
                                                       (caAERS)     v3
                              Patient   HL7
                              Study     V3
                             Calendar
                                                                                 NCI




                                              HL7 v3
                                               ICSR
                                 HL7                               HL7 v3     Repository
                    HL7
          Lab                     v3                                “Style”
         System      v2
                                                                    CTOM
                                                                     ICSR

                    v2        Lab
          Lab
                              Data
         System
                              Hub        HL7
                    v2                    v3
                                                         C3D
          Lab                            LAB
         System                          MSG
                                                         Lab
                                         HL7            Loader
                                          v3
                                                        Other
                                         LAB
                                                        CTMS
                                         MSG
                                                       Systems
                   Lab
                Repository




                                                                                           24
    Clinical Trials Management Workspace,
    Circa November 2006
• CTMS Governance
• Development Projects
   – Patient Study Calendar (December 2006 completion)
   – Lab Hub Interface (caXchange) (December 2006 completion)
   – Protocol Lifecycle Management (Inception Phase November 2006
     completion)
• RFPs
   – C3PR Phase 2 (Awarded and under development)
   – caAERS Phase 2 (Awarded and under development)
   – Protocol Lifecycle Management Phase 2 (RFP is on the street)
• CTMS Interoperability Project (under development)




                                                                    25
    Clinical Trials Management Workspace,
    Circa November 2006 (continued)
• CTWG
   – Clinical Trials Data Base (CTDB) project (under development)
   – Systems Interoperability & Harmonization (SIH) project (under
     development)
   – Case Report Forms (CRF) project (under development)
   – Investigator & Site Credentialing (ISC) project
   – Study Initiation Tool (SIT) project
• 7 Cancer Centers utilizing C3D infrastructure (Including 3 C3PR
  adopters)
• BRIDG Model:
   – Used as modeling foundation for all CTMS development projects
   – Harmonized with caXchange and Study Calendar
   – Planned: SDTM (December), C3PR, caAERS, PLT (Q12007)


                                                                     26
     Clinical Trials Management Workspace,
     Circa November 2006 (continued)
• Clinical Trial Reporting:
   – CDS Pilot testing for Analysis and Reporting module and Protocol
     Abstraction
• Financial Billing
• Standard Operating Procedures: 26 Published SOPs, 3 draft




                                                                        27
Agenda

• Welcome and Introductions
• CTMS Progress
  – Where Have We Been And Where Do We Think We’re
    Going?
  – Progress since July 2006
• CTMS Program Management
• CTMS Strategic Next Steps




                                                     28
 How do/will we manage all this ???

• Unified Process Framework
• Layered and cross-project Coordination and
  Management
   – CTMS projects
   – caBIG™ projects




                                               29
Program Management: Unified Process
Framework (UPF)
•   Industry Best Practices for solving complex problems
•   UPF Core Principles
     – Multi-disciplinary project teams
         • Clinical Research expertise, informatics expertise,
            leadership expertise
     – Continuous, structured risk management of project risks
         • Early identification of risks to project, formal
            mitigation/contingency plans
     – Iterative/incremental product development
         • Deliver increasingly functional prototypes early and often
     – Focus on underlying architecture as pre-requisite for
        scalability and extensibility of initial product
         • Assume constantly changing functionality




                                                                        30
                             A Unified Process Framework
        (Iterative, Incremental, Risk-Focused, Architecture-Centric)
                                                               Phases
                             Inception     Elaboration              Construction            Transition      Production /
                                                                                                              Support
            Governance

    Project Management

Stakeholder Management

 Business Requirements

  Requirements Analysis

               Analysis

                 Design

        Implementation

       Business Testing

    Performance Testing

  Technical Architecture

       Data Conversion

              Transition

 Operations and Support
                                         Elab.     Elab.   Const.      Const.      Const.   Tran.   Tran.   Prod.   Prod.
                Iterations     Initial
                                          #1        #2      #1          #2          #3       #1      #2      #1      #2

              Milestones




                                                                                                                            31
                                                   Operational Model
                                   Focus on Risk, Relevance, and Quality
                                                         Lifecycle I                       Lifecycle II
                              Inception   Elaboration             Construction   Transition Inception
                                Phase        Phase                  Phase          Phase      Phase
Multi-disciplinary Workflow




                                                 Structured Risk Management
                                                 Structured Risk Management

                                                         Project Plan
                                                         Project Plan


                               Vision
                               Vision
                                and
                                and       Refine Vision and
                                          Refine Vision and
                               Scope
                               Scope           Scope
                                                Scope


                                                   Multi-dimensional Team
                                                   Multi-dimensional Team




                                                                                                          32
 Multiple contributing factors to complexity
  •    The combination of multiple vertical levels of organization and cross-
       organization processes– involving people or systems
        – Problems occur at the ‘crossing points’
             • Understanding: syntax and semantics
             • Politics: responsibility and accountability
  •    Cumulative experience in industry, art, and (cognitive) science has
       repeatedly shown that the best way to deal with complexity is through
       abstraction, layering, and the use of standards.
  •    Disparate (unstructured) approaches to different processes lead to
       unorganized behavior

          Hierarchical
         Accountability




Cross-organization Processes


                                                                                33
Agenda

• Welcome and Introductions
• CTMS Progress
  – Where Have We Been And Where Do We Think We’re
    Going?
  – Progress since July 2006
• CTMS Program Management
• CTMS Strategic Next Steps




                                                     34
      What is the CTMS 3-5 Year Plan?

•   What are the highest priorities for CTMS in the next 3-5 years?
•   Do we continue to build on the projects that are currently underway to add
    additional functionality? Or do we add new projects? Or both?




                                                                                 35
      Summary & Next Steps

•   Begin working under the new governance structure to support the coordination and
    direction of the workspace
•   Impose Best Practices for managing complex problems and building complex
    solutions
     – Unified Process Framework
     – Layered Project Management
•   Continue collaboration with the NCI research community to build consensus on
    priorities
•   SIGs:
     – Do the current SIGs align with CTMS priorities?
     – Continue to focus on requirements
     – Continue to leverage BRIDG in the context of requirements definition of
        specific solutions
     – Test, vet and provide feedback on software that is being built for you – The NCI
        Research Community


                                                                                 36
      Summary & Next Steps (Continued)
•   Expand the community to include:
     – Cooperative Groups, Community Clinical Oncology Programs (CCOPs),
        Specialized Programs of Research Excellence (SPOREs), NCI Intramural and
        Extramural parties
     – Principle Investigators, Research Nurses, Study Coordinators and other “end
        users” from the NCI research community
•   Encourage collaborative partnerships between academic and/or commercial
    organizations combining organizations with deep subject matter expertise with
    organizations that develop software following best practices in software
    engineering




                                                                              37
QUESTIONS
 ANSWERS




            38

				
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