Clinical Data Interchange Standards Consortium

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• Clinical Data Interchange Standards Consortium
• Pharma R D Directions Conference
• Cancun, Mexico, 12-14 February 2002
• Rebecca Kush, PhD, CDISC and Catalysis, Inc.
• Stephen Ruberg, PhD, Eli Lilly Company
• Charles Jaffe, MD, PhD, AstraZeneca

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Its All About the Data

• The Potential Impact of
• Clinical Data Standards on
• Your Organization

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Data Information, the Essence of Clinical
Research
Data
Molecule Value
?The more data collected, the higher the
potential value of the molecule.
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Data Interchange

• Data Interchange - the exchange of information
  between two or more parties.
• The CDISC Glossary Group distinguishes data
  interchange from simple data transfer in that it
  requires that the integrity of the contents of
  the data must be preserved and that it serves the
  intended purpose.
• It is also important that the information
  transferred be readily comprehended by the
  recipient, which may require that the information
  be accompanied by metadata (data about the data).
  

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How Important is Metadata?
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In this case 125,000,000,the price of a Mars
Climate Orbiter
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A Case for Data Standards
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Current State Costly and Time-consuming
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CDISC Value Cost of Clinical Data Interchange
in Clinical Trials

• 7,000-8,000 clinical studies/year
• 30 outsourced and 5-10 EDC
• Estimated cost of 35,000 for EDC transfers,
  25,000 for CRO data transfers, and 10,000 for
  lab data transfers
• Conservative Annual Cost to the Industry
• 156 million
• NOTE The costs incurred with development
  partners or merged
• companies sharing data and the cost of preparing
  data for eSubmissions
• are not addressed in this set of calculations,
  nor are other costs such as
• training, planning or equipment.

CDISC White Paper on Website Source CenterWatch
(v.7, issue 11)
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Desired State
Pharma
Labs
Tech/Software
CDISC Data Standards
Other Vendors
Biotech
Regulatory
Patients
CROs
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Clinical Data Interchange Standards Consortium

• CDISC is an open, multidisciplinary, non-profit
  organization committed to the development of
  worldwide industry standards to support the
  electronic acquisition, exchange, submission and
  archiving of clinical trials data and metadata
  for medical and biopharmaceutical product
  development.
• The CDISC mission is to lead the development of
  global, vendor-neutral, platform-independent
  standards to improve data quality and accelerate
  product development in our industry.

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History of CDISC

• Initiated 1997 as a volunteer organization
• Invited to be a DIA SIAC for 2 years
• Incorporated as non-profit organization in
  February 2000 and funded by Corporate Sponsors
  that year
• gt 60 Sponsors and Members
• International presence (liaison groups in Europe
  and Asia-Pacific Region)

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CDISC Scope and Strategic Direction for
Modeling Efforts

• Data Sources
• Site CRFs
• Laboratories
• Contract
• Research
• Organizations
• Development
• Partners
• Discovery Data

• Operational
• Database
• Study Data
• Audit Trail
• Metadata

• Submission Data
• CRT Datasets
• Analysis datasets
• Metadata

ODM LAB
SDM ADaM
ODM Operational Data Modeling LAB Laboratory
Data Modeling SDM Submissions Data
Modeling ADaM Analysis Data Modeling
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CDISC Teams - Recent Accomplishments

• SDS - Metadata Models for eSubmissions, completed
  Version 2.0 November 2001
• ADaM - Guidelines for the Creation of Analysis
  Filesfor Submissions examples of analysis
  dataset models - October 2001
• ODM - XML-based Model, completed Version 1.1,
  supports Electronic Data Exchange and Archive for
  operational data October 2001
• LAB Completed Content Data Model for Clinical
  Laboratory Data Exchange November 2001

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Implementing CDISC Data Standards

• Submissions Data Standards (SDS)
• FDA pilot for Patient Profile Viewer (PPV)
  Because a limited number of voluntary
  participants are needed, the agency will use its
  discretion in choosing volunteers, based on their
  experience with providing CRTs and their
  familiarity with the standards recommended by
  CDISC. Federal Register / Vol. 66, No. 237
  / Monday, December 10, 2001
• Version 2.0 is compatible with the ICH E2B
  standard for adverse event reporting
• Analysis Dataset Models (ADaM)
• CBER and CDER Statisticians have indicated their
  interest in this important work and are testing
  models.

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Improving Case Report Tabulation (CRT) Review
Depends on Data and Metadata Standards

• Patient Profile Viewer Pilot
• ADaM (Analysis Dataset Models)
• Update current guidances (and regulations?)
• CDISC it!

(S. Wilson, FDA Reviewer)
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Implementing CDISC Data Standards

• Operational Data Model (ODM)
• Demonstrated connectivity
• 23 participants (pharmaceutical companies, CROs,
  technology providers) for Connectathons
• US July 2001 and Europe - October 2001
• Lower rates offered by Electronic Data Capture
  (EDC) technology providers for data transfers
  using CDISC model
• Laboratory Data Model (LAB)
• Has been tested between pharmaceutical companies
  and clinical laboratories
• One Clinical Laboratory 1200 interfaces to
  support data transfers incentive for standards

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Eli Lilly Experience

• Global standards - a cornerstone in the
  foundation of the Eli Lilly e-data management
  program.
• Developing standards initially perceived as a
  long task, with difficulty in reaching agreement
  across geographies.
• Created 138 CDISC-based safety standards in 10
  weeks, using more than 70 reviewers around the
  world.
• Recently delivered initial set of efficacy
  standards.
• Now 95 of initial standards work is complete.

(P. Hrubey, Eli Lilly Co.)
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Eli Lilly Unleash the Power of Data

• eBusiness is creating an environment
• that fosters innovation around
• the molecule not around the
• data or the process.

(P. Hrubey, Eli Lilly Co.)
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Aventis Experience

• Why CDISC?
• The Origins
• The Focus
• The Participation
• The Philosophy
• The Timing
• XML CDISC Compliance are Part of the Criteria
• in Evaluation of Potential CRO Partners
• Choice of 3rd Party Service Providers (Central
  Labs)
• New Technologies

(E. Job, Aventis Pharmaceuticals)
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Old Aventis Adverse Event Data Collection Form
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New Aventis AE Form
Includes only the items we NEED
Codelists match CDISC
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CDISC Web Survey - Respondents
37 CDISC Sponsors
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Use of CDISC Models

• Plan to use the CDISC Models
• ODM 65 (tested or used 29)
• SDM 66 (tested or used 22)
• ADaM 45 (tested or used 5)
• LAB 51 (tested or used 11)
• Two respondents have submitted data to the FDA
  using the CDISC models.
• 79 are willing to require CRO or vendor to use
  CDISC models (or comply with models as a CRO or
  vendor)

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CDISC Principles

• Lead the development of standard data models that
  improve process efficiency while supporting the
  scientific nature of clinical research.
• Recognize the ultimate goal of creating
  regulatory submissions that allow for flexibility
  in scientific content and are easily interpreted,
  understood, and navigated by regulatory
  reviewers.
• Acknowledge that the data content, structure and
  quality of the standard data models are of
  paramount importance, independent of
  implementation strategy and platform.

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CDISC Principles

• Maintain a global, multidisciplinary,
  cross-functional composition for CDISC and its
  working groups.
• Work with other professional groups to encourage
  that there is maximum sharing of information and
  minimum duplication of efforts.
• Provide educational programs on CDISC standards,
  models, values and benefits.
• Accomplish the CDISC goals and mission without
  promoting any individual vendor or organization.

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Alliances

• Alliance Principles
• CDISC has a goal to collaborate with other groups
  interested in standards development
• CDISC does not wish to duplicate efforts
• FDA - has appointed Liaisons to CDISC
• Current collaborations - National Cancer
  Institute, Global Data Management Organizations
  (SCDM, NCDM, ACDM, DMB, ARCS), Drug Information
  Association (DIA), I3C (genomics)
• Formal association with Health Level 7 (March
  2000)
• Active FDA-HL7-CDISC Working Group
• Opportunity to bring healthcare together with
  clinical research
• Opportunity for accreditation of CDISC standards

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CDISC Near-Term Objectives

• Continue to support needs of regulatory agencies
  for electronic submission of data.
• Continue to support, educate and increase use of
  CDISC operational models.
• Develop additional standards as appropriate to
  support clinical trials.
• Increase collaboration with other organizations
  interested in standards and harmonization to
  improve the clinical development process.
• Expand activities in Europe and Asia.

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Standards to Enable Seamless Data Flow .from
Patient to Reviewers
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Reasons to Participate Actively

• Maximizing your input by contributing to the
  development of the standards at an early stage
• Obtaining early access to the evolving models
• Receiving hands-on experience for corporate
  personnel on implementation, methodology and
  nuances of the models
• Providing strategic direction to CDISC
• Realizing earlier financial benefits (avoiding
  the price of indifference.)
• Collaborating with others who wish to improve
  drug development

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• CDISC has been made possible by
• NUMEROUS companies and individuals
• who have dedicated their
• time and expertise.
• Thank you!

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CDISC Contact Information

• Website (www.cdisc.org)
• Models for review
• Presentations
• Updates and White Papers
• Coming Events
• E-Mail
• Swilliams_at_cdisc.org
• rkush_at_cdisc.org
• Phone [phone]