Clinical Trial Working Group Business Meeting and Panel Discussion

1
Clinical Trial Working GroupBusiness Meeting and
Panel Discussion

• AMIA 2006 Annual Symposium
• Hilton Lincoln West
• November 14, 2006
• Tuesday 515 715 PM

2
Agenda

• 2006 Review Charlie Barr
• 2007 Preview Stan Kaufman
• Panel Research Informatics Initiatives and
  Opportunities for AMIA
• Group Discussion Philip Payne, Peter Embi

3
2006 Officers

• Charlie Barr, Chair
• Stan Kaufman, Chair-Elect
• Judy Logan, Secretary

4
2006 Changes

• Officers Team structure for outreach input
• Communications Listserv, website,
  teleconferences
• CMS Policy on Clinical Research
• Usability labs
• Ontologies for representing clinical trial
  eligibility criteria
• Goals and projects Collective input review
• Educational Outreach Web Seminars (AMIA, CDISC)
• Collaboration Panel, Book, CDISC CDASH
• Proposed Names for CT-WG
• Clinical Research Informatics (CRI-WG)
• Clinical Research (CR-WG)
• Clinical Translational Research (CTR-WG)

5
AMIA / CDISC Webinar Series

• Ida Sim WHO International Clinical Trial
  Registry Platform
• Ed Helton, Steve Wilson, Cathy Barrows
  Regulatory Submission using the CDISC SDTM and
  ADaM
• Charles Jaffe Global Trial Bank
• Why Clinical Development Teams Should Care about
  Data Standards
• Becky Kush, Ed Helton, Sally Cassells, Dave
  Iberson-Hurst Part I. An Introduction to the
  CDISC Operational Data Model (ODM)
• Becky Kush, Ed Helton, Sally Cassells, Anthony
  T Friebel. Part II The Inner Workings of the
  ODM
• Becky Kush, Ed Helton, Bill Qubeck, Gary Walker,
  Armando Oliva. Part III Real World Experiences
  with the ODM
• Doug Fridsma The Biomedical Research
  Integrated Domain Group (BRIDG) Model

6
2006 CT Expo

• Review Committee
• Judy Logan, Chair
• Stan Kaufman
• Peter Embi
• Philip R.O. Payne
• 16 demos and posters
• Section of Exhibit Hall, concurrent with posters

7
CDISC CDASH

• Clinical Data Acquisition Standards Harmonization

8
2007 Officers

• Stan Kaufman, Chair
• Peter Embi, Secretary
• Members-At-Large
• Charles Jaffe
• Stephen Johnson
• Judith Logan
• Philip R.O. Payne
• Justin Starren
• Frank Sullivan

9
2007 Plans

• Annual Fall Symposium
• Scientific Sessions Papers, posters, panels
• Proposals due in March
• Expo
• Position paper for JAMIA
• Book - Clinical Research Informatics

10
Panel Planning Committee

• Philip R.O. Payne, M.Phil.
• Charlie Barr, MD, MPH Chair, CTWG
• Peter Embi, MD, MS
• Stan Kaufman, MD Chair-Elect, CTWG
• Judith Logan, MD, MS Secretary, CTWG

11
Panel - Presenters

• Ida Sim, WHO, UCSF Global Trial Bank
• Doug Fridsma, U. Pitt. BRIDG
• Steven Johnson, Columbia U. NIH Roadmap, CTSA
• Joyce Niland, City of Hope caBIG
• Amar Chahal, Velos IT industry
• Becky Kush, CDISC Data standards
• Ed Sequine, Fast Track IT industry

12
Panel - Objectives

• Describe goals, learnings, barriers, status
• Compare to other initiatives identify
  links/gaps viewpoint of overall framework
• Identify roles for AMIA and the WG

13
Critical Success Factors

• Landscape or framework for perspective
• Facilitate determining What is an important,
  big (but potentially solvable) problem
• Prioritize and focus energy, expertise, and
  resources
• Build the solution

14
PANEL DISCUSSION
15
Discussion - Objectives

• Define the position of AMIA / CTWG on fostering
  such collaboration / integration
• Establish a core group and set of topics and
  tasks for the preparation of a position paper for
  submission to JAMIA

16
Expected Outcomes

• Identify key initiatives to evaluate
• Potential projects or activities
• Identify potential collaborators (AMIA WGs,
  industry, etc.)
• Identify funding needs and potential sources

17
Panel - Discussion Topics

• What are the goals and synergies of the major
  initiatives?
• What are the gaps, key obstacles, and barriers?
• What are the opportunities? Is it in standards,
  infrastructure, coordination,
• How could an organization like AMIA CTWG provide
  value?
• What precautions do you have? How should AMIA
  avoid duplication?