CDISC Inclusion/Exclusion Standardized Coding Project:

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CDISC Inclusion/ExclusionStandardized Coding
Project

• ASPIRE
• Agreement on Standardized Protocol Inclusion
  Requirements for Eligibility

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ASPIRE Project Participants

• Joyce Niland, Lead City of Hope jniland_at_coh.o
  rg
• Elly Cohen, Co-Lead UCSF Elly.cohen_at_ucsfmedct
  r.org
• Greg Eoyang, Admin Lead Digital Infuzion
• grege_at_digitalinfuzion.com
• Lakshmi Grama NIH
• lgrama_at_mail.nih.gov
• Cortney Hayflinger GSK
  Cortney.d.hayflinger_at_gsk.com
• Robert Wang ClinTrialStat
• clintrialstat_at_yahoo.com
• Jeffrey Suico LLCR
• suicoje_at_lilly.com
• Charles Barr Roche Laboratories Inc
  charles_e.barr_at_roche.com

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The Challenge We FaceStatistics from Oncology

• According to the research literature
• Over 1.2 million patients are diagnosed with
  cancer in the U.S. each year
• Somewhere between 12 and 44 of all
  cancerpatients are eligible for clinical trial
  enrollment
• Only 1 to 3 of eligible patients
  actuallyparticipate
• If only 10 of eligible patients participated
  inoncology clinical trials, trials could be
  completedmuch more rapidly than the current 3-5
  years
• Corresponding increased rates of new
  drugdevelopment and availability

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Potential Questions to be Answered via
Standardized Coded Eligibility Criteria

• Patients/Providers/Family Members
• Does a specific center have an open trial formy
  condition?
• Investigators
• Who and where are my potential collaborators and
  competitors?
• Sponsors
• Where can I run my new trial so that it
  doesntoverlap with a centers other trials?
• Centers
• How can we disseminate information to increase
  and/or expedite patient accrual?

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Charter Mission of the ASPIRE Subcommittee

• Charter
• To serve as a subgroup of the CDISC Protocol
  Representation Committee, charged with developing
  proposed standardized method(s)of encoding
  protocol eligibility criteria, using accepted
  medical terminology and vocabulary standards
• Mission
• To facilitate more rapid efficient screening of
  potential participants for available clinical
  trials worldwide, to help speed the discovery of
  new interventions to treat, prevent or screen
  for disease among patients, and to serve as the
  underpinning for various technical
  implementations to facilitate subject screening
  and recruitment

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Key Deliverable Pan-Disease and Disease-Specific
Coded Core Eligibility Criteria

• Agreement upon a core set of standardized
  eligibility codes, pan-disease and
  disease-specific, that cut across many studies
• Not an attempt to fully code or automate full
  inclusion/exclusion criteria for protocols
• Augments protocol registration data
• Facilitates disease-specific coded searches to
  filter available protocols based on patients
  presenting characteristics

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Sample Use Case City of Hope Breast
Cancer-Specific Protocol Search Filter
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Pros/Cons of Disease-Specific Coded Core
Eligibility Criteria

• Advantages
• Facile / practical to code new protocols becomes
  part of electronic instantiation of protocol
• Rapidly enhances patient/provider capability to
  identify potential trials while eliminating
  inappropriate studies, or data mining to ID
  patients (cast wide net, avoid false
  negatives)
• Disadvantages
• Doesnt automatically match patient to protocol
  (very difficult to achieve, timing of tests,
  experimental tests, etc.)
• Requires much work to cover many diseases

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Activities to Date and Future

• To Date
• Submitted as official sub-project with HL7 RCRIM
• Held numerous conference calls to discuss core
  eligiblity criteria
• Completed pan-disease criteria, and
  disease-specific criteria for breast cancer and
  diabetes
• Vetted twice with CDISC Protocol Representation
  Group
• Harmonized with WHO registry elements, STDM,
  CDASH Pkg. 2 (and BRIDG in future)

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Activities to Date and Future

• Future
• Tackling pediatric hypertension as next disease
  (per CDISC pilot)
• Joining HL7/OMG Clinical Research Filtered Query
  project to provide sample use case to exercise
  the filter message
• Conducting an evaluation plan using breast cancer
  criteria
• Propose to code all breast cancer trials in PDQ
  for core eligibility
• Requesting permission to utilize NCCN database of
  gt30,000 coded breast cancer patients from last 10
  years
• Apply filter algorithm to match patients to
  open protocols and determine yield
• Follow with bootstrapping technique to drop out
  one criterion at a timeand reevaluate protocol
  match yield

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3 Tiers of Clinical Trial Objects
ProtocolRegistered
Higher RiskProtocol
Available for Accrual
Available for Accrual
ProtocolTier
Conditions met,N slots available
Registration
Consentmodification
N 1slots Available
ConceptApproved
Suggestedfor Protocol
PatientRegistered
FullyEligible
Consented
RXHeld
Study ConductTier
On-Study
.
Treatment Monitoring
AE
Eligibility Screening
ConsentingProcesses
AccessioningProcesses
Eligibility Filtering
Data Tier
ConsentForm
SAEReport
Eligibility Checklist
Form A
City of Hope
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Questions/Discussion