Clinical Trial Management Systems Workspace Newcomer Session by NIHhealth

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									National Cancer Institute

                            The caBIG™ Clinical Trials
                            Management Systems

                            John Speakman
                            Memorial Sloan-Kettering Cancer
National Cancer Institute
                            Translating Molecular Understanding to
                            Patient Outcomes – how are we doing?
                            • Deaths per 100,000 people declining 1% per year
                            • Five year survival 63%; ten million cancer survivors
                              in USA (Note: early detection doesn’t mean a longer

                            • Cancer is now #1 cause of death in Americans
                              under age 85 (age-adjusted)
                            • 1,500 Americans die of cancer every day
                            • 1.5 million new cases every year
                            • Cost of cancer in USA estimated by NIH in 2004 at
                              $190bn/yr (medical costs, lost productivity)
National Cancer Institute
                            FDA (Innovation or Stagnation, aka
                            Critical Path, Woodcock 2004):
                            • Explosion of knowledge from biological research,
                              continued growth in research spending
                            • Slowdown in innovative therapies reaching
                               – as measured by the number of new submissions to FDA
                            • “The [drug development] process has not kept up
                              with basic scientific innovation”
                            • 8% of drugs entering Phase I get to the market
                            • “For drugs entering human clinical trials for the
                              first time between 1989 and 2002 [average] cost
                              per new drug [was] $868 million […] $500 million
                              to more than $2,000 million […]
                               – Health Affairs 25, no. 2 (April 2006)
National Cancer Institute
                            National Cancer Advisory Board Clinical
                            Trials Working Group Report (July 2005)
                            • “Re-engineering the Cancer Clinical Research
                            • Initiative: Promote the establishment of national clinical trial
                              information technology infrastructures that are fully
                              interoperable with NCI’s cancer Biomedical Informatics Grid
                                – “The long-term goal is for all clinical trial sites either to migrate
                                  to the caBIG™ architecture or to develop interfaces and other
                                  required enhancements such that their IT architecture is fully
                                  interoperable with the caBIG standards-based infrastructure.”
                            • Initiative: Establish a comprehensive National Clinical Trials
                              Database, developed in concert with caBIG™, to hold:
                                – Descriptive information on trial status, clinical trial results, links
                                  to published or presented data
                                – Site submission will be “routine” within three years (i.e., by
                                  Sept. 2008)
National Cancer Institute
                            CTWG Standardization Initiatives
                            • Create Standard Clinical Research Tools
                              – Establish national cancer clinical trials IT
                                infrastructure – standards and standards-based
                                tools – (i.e., caBIG™)
                            • In consultation with industry and FDA,
                              develop standard Case Report Forms
                              incorporating Common Data Elements
                              – Accessible through caBIG™ for unrestricted
                            • Build a credentialing system for
                              investigators and sites recognized by NCI
                              and industry
                              – Firebird
National Cancer Institute
                            • Automates and
                              centralizes the

                            • Enables
                              investigators to
                              register online
                              with sponsors

                            • Proves the
                              feasibility and
                              value of CRIX
National Cancer Institute
                                What’s CRIX? Clinical Research
                                Information Exchange
                            •   Grew out of       Global
                                NCI-FDA Inter- Data
                                                  Sources                       Regulated Data Flow
                                Oncology Task
                                Force (IOTF) Bio-Tech/Pharmaceutical/ Medical                                 Regulators
                                                            Device Mfrs

                            •   Collaboration
                                to implement a
                                common,                     Regulated
                                                                                   CRIX                         Regulated
                                standards-                    Flow                                                Flow
                                for regulatory        Regulated
                                submission,           Flow                       Regulated Data Flow
                                review and
                                                               CROs                                     Investigators/Physicians
                                                     (industry/Academia/Govt)                          (Industry/Academia/Govt)
National Cancer Institute
                                       CRIX Objectives
                            • Less manual, paper processing in FDA
                            • Less time on orientation to data by FDA
                            • More auditable data
                            • Less ambiguity in communications of information
                            • More efficient submission based on standards
                            • Reproducible, custom datasets for analysis
                            • Reusable tools for analysis and review
                            • Easier cross-study analyses
                            • Less data redundancy
                            • Use of common standards across the entire
                              community (government, industry, academia)
                            • Interoperability with caBIG data sets, tools,
National Cancer Institute
                            President’s Cancer Panel Report
                            • There is “no academic base” to the
                              conduct of clinical trials
                            • Translation: the discipline needs to have
                              some formality imposed
                            • One part of this is harmonizing best
                            • Our attempt to impose formality within data
                              representation is called BRIDG
                              (Biomedical Research Integrated Domain
National Cancer Institute
                            What is BRIDG?
                            • A strategic initiative involving caBIG™ and:
                               – the Clinical Data Interchange Standards Consortium
                               – Health Level Seven (HL7)
                              to develop a single domain representation
                              standard for clinical research
                               – i.e., a formal domain analysis model of the shared
                                 semantics of clinical research
                               – Will ensure semantic interoperability, e.g., “what’s a
                            • BRIDG will incorporate existing CDISC
                            • In caBIG™, BRIDG will form the basis of
                              interoperable clinical trial tool development
National Cancer Institute
                             Today’s Clinical Trial Protocol
                            One full-text source presented several ways

                                                       Database           Protocol
                                                        Creation          Database
                                                      And Curation
                            RTF     PDF       Paper

                                                       Adapted from Greg Anglin, Eli Lilly
National Cancer Institute
                            Example BRIDG Application:
                            Tomorrow’s Clinical Trial Protocol could be
                            a data layer in the full-text source

                                         Consistency guaranteed

                             Protocol                             Protocol
                            Document                              Database
National Cancer Institute
                                     Domain priorities for caBIG™ pilot
                                                              Database & Datasets
                                                      Imaging Tools & Databases
                                                    High Performance Computing
                                                                         Pathways                          Clinical Trial
                                                                  Licensing Issues                         Management
                             Laboratory Information Management Systems (LIMS)                              Systems
                                           Microarray & Gene Expression Tools
                                                                       Proteomics                          Tissue
                                                                Remote/Bandwidth                           Banks
                                                  Visualization & Front-End Tools                          & Pathology
                                                    Statistical Data Analysis Tools
                                        Vocabulary & Ontology Tools & Databases                            Integrative
                                                                      Meta-Project                         Cancer
                                    Common Data Elements (CDE) & Architecture                              Research
                                                Center Integration & Management
                                                      Tissue & Pathology Tools
                                                                   Access to Data
                                                  Translational Research Tools
                            Distributed General Data Sharing & Analysis Tools
                                                                   Staff Resources
                                  Clinical Data Management Tools & Databases
                                                                                   0   5   10   15    20   25      30       35
                                                                                            Number of Needs Reported
National Cancer Institute
                            Priority Areas Within CTMS
                            • Adverse Event Reporting
                            • Laboratory Interface
                            • Routine NCI Reporting (i.e., CDUS /
                              Theradex, Summary 3 and 4)
                            • Financial / Billing
                            • Structured Protocol Representation
                            • Study Calendar
                            • Best Practices
National Cancer Institute
                            2006 Clinical Trial Tools Development
                            • Cancer Adverse Event Reporting
                              System (caAERS)
                            • Patient Study Calendar System
                            • Laboratory Data Hub
                            • Making other CTMS systems caBIG
National Cancer Institute
                            What’s available today
                            • Cancer Central Clinical Database (C3D)
                              – A soup-to-nuts clinical trial data management
                              – Based on common data elements
                              – Host-it-yourself or ASP (hosted at NCI)
                              – Not free (based on Oracle®)
                              – Automatic lab values loading and CTC grading
                              – Extraction to Theradex and CDUS
                              – Based on template forms composed of CDEs
National Cancer Institute
                             Clinical Trials Management: Three
                             Levels of Interaction Based on
                             Institutional Readiness
                             No Existing System

                                                                  C3D Adoption                    Additional

                            Existing System:                     exchange data
                            Change Imminent

                                                                             New caBIG modules      caBIG Open Source
                                                                                                     Core Functionality     Interoperable
                                                                                                                          caBIG Community
                            Existing System:      caBIG compatibility
                               No Change          efforts with vendor
National Cancer Institute
                            Pilot Project : caMATCH
                            Personalized matching of patient
                            medical histories to clinical trials
                            • A patient-centric online clinical trials matching
                              program in a pilot project for breast cancer
                              patients in the San Francisco Bay Area

                            • Sponsored by the University of California San
                              Francisco and caBIG™

                            • 2007 Relaunch: Nationwide listing of trials
National Cancer Institute

                                                     Personal Health
                                                      Trial Criteria

                                                     Matching Rules
                            1. Patient self-reports              2. BCT returns matches
                            medical history                      with trial summaries,
                                     3. Patient calls            contact information
                                     research site, sends
                                     Personal Health
                                     Record securely
                                          4. Patient Visits research site,
                                          research staff determine
                                          eligibility, patient elects
                                          whether to enroll         Source: Elly Cohen, UCSF
National Cancer Institute

                                                    That’s it!



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