The caBIG Clinical Trials Management Systems Workspace John Speakman Memorial SloanKettering Cancer

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The caBIG Clinical Trials Management Systems
WorkspaceJohn SpeakmanMemorial Sloan-Kettering
Cancer Center(SpeakmaJ_at_mskcc.org)
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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 doesnt
  mean a longer life)
• BUT
• 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)

3
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
  patients
• 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)

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National Cancer Advisory Board Clinical Trials
Working Group Report (July 2005)

• Re-engineering the Cancer Clinical Research
  Enterprise
• Initiative Promote the establishment of
  national clinical trial information technology
  infrastructures that are fully interoperable with
  NCIs 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)

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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 use
• Build a credentialing system for investigators
  and sites recognized by NCI and industry
• Firebird

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Firebird

• Automates and centralizes the 1572 registration
  process
• Enables investigators to register online with
  sponsors
• Proves the feasibility and value of CRIX

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Whats CRIX? Clinical Research Information
Exchange

• Grew out of NCI-FDA Inter-Agency Oncology Task
  Force (IOTF)
• Collaboration to implement a common,
  standards-based electronic infrastructure for
  regulatory submission, review and analysis

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CRIX Objectives

• Less manual, paper processing in FDA
• Less time on orientation to data by FDA reviewers
• 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,
  capabilities

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Presidents Cancer Panel Report 2005

• 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 practices
• Our attempt to impose formality within data
  representation is called BRIDG (Biomedical
  Research Integrated Domain Group)

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What is BRIDG?

• A strategic initiative involving caBIG and
• the Clinical Data Interchange Standards
  Consortium (CDISC)
• 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.,
  whats a protocol?
• BRIDG will incorporate existing CDISC standards
• In caBIG, BRIDG will form the basis of
  interoperable clinical trial tool development

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Todays Clinical Trial Protocol
One full-text source presented several ways
Full-text protocol
Protocol Database
Paper
PDF
RTF
Adapted from Greg Anglin, Eli Lilly
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Example BRIDG ApplicationTomorrows Clinical
Trial Protocol could be a data layer in the
full-text source
Consistency guaranteed
Protocol Document
ProtocolDatabase
BRIDG Data Layer
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Domain priorities for caBIG pilot
Database Datasets
Imaging Tools Databases
Integration
High Performance Computing
Pathways
Licensing Issues
Laboratory Information Management Systems (LIMS)
Meeting
Microarray Gene Expression Tools
Proteomics
Remote/Bandwidth
Visualization Front-End Tools
Statistical Data Analysis Tools
Vocabulary Ontology Tools Databases
Meta-Project
Common Data Elements (CDE) Architecture
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
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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

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2006 Clinical Trial Tools Development Activities

• Cancer Adverse Event Reporting System (caAERS)
• Patient Study Calendar System
• Laboratory Data Hub
• Making other CTMS systems caBIG compatible

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Whats available today

• Cancer Central Clinical Database (C3D)
• A soup-to-nuts clinical trial data management
  system
• 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

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Clinical Trials Management Three Levels of
Interaction Based on Institutional Readiness
No Existing System
Additional Functionality
C3D Adoption
Existing System Change Imminent
exchange data
New caBIG modules
caBIG Open Source Core Functionality
Interoperable caBIG Community
Existing System No Change
caBIG compatibility efforts with vendor
Additional Functionality
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Pilot Project caMATCHPersonalized 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

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caMATCH www.breastcancertrials.org
Database
Trial Criteria
1. Patient self-reports medical history
2. BCT returns matches with trial
summaries, contact information
3. Patient calls 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
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Thats it!

• SpeakmaJ_at_mskcc.org

http//integratedtrials.nci.nih.gov/ict/CTWG_repor
t_June2005.pdf