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Clinical Data Interchange Standards Consortium

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Cancun, Mexico, 12-14 February 2002. Rebecca Kush, PhD, CDISC and Catalysis, Inc. ... Stephen Ruberg, PhD, Eli Lilly & Company. Charles Jaffe, MD, PhD, ... – PowerPoint PPT presentation

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Title: Clinical Data Interchange Standards Consortium


1
  • 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

2
Its All About the Data
  • The Potential Impact of
  • Clinical Data Standards on
  • Your Organization

3
Data Information, the Essence of Clinical
Research
Data
Molecule Value
?The more data collected, the higher the
potential value of the molecule.
4
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).

5
How Important is Metadata?
6
In this case 125,000,000,the price of a Mars
Climate Orbiter
7
A Case for Data Standards
8
Current State Costly and Time-consuming
9
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)
10
Desired State
Pharma
Labs
Tech/Software
CDISC Data Standards
Other Vendors
Biotech
Regulatory
Patients
CROs
11
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.

12
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)

13
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
14
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

15
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.

16
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)
17
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

18
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.)
19
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.)
20
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)
21
Old Aventis Adverse Event Data Collection Form
22
New Aventis AE Form
Includes only the items we NEED
Codelists match CDISC
23
CDISC Web Survey - Respondents
37 CDISC Sponsors
24
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)

25
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.

26
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.

27
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

28
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.

29
Standards to Enable Seamless Data Flow .from
Patient to Reviewers
30
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

31
  • CDISC has been made possible by
  • NUMEROUS companies and individuals
  • who have dedicated their
  • time and expertise.
  • Thank you!

32
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 512-341-9885
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