Transcript Healthcare Link Initiatives: Bridging Clinical Research and Healthcare Clinical Observations Interoperability Telcon 28 August 2007 Landen Bain CDISC Liaison to Healthcare.

Healthcare Link Initiatives:
Bridging Clinical Research and
Healthcare
Clinical Observations Interoperability
Telcon
28 August 2007
Landen Bain
CDISC Liaison to Healthcare
Mission Statement
The mission of CDISC is to develop
and support global,
platform-independent data
standards that enable information
system interoperability
to improve medical research and
related areas of healthcare.
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Clinical Data Interchange
Standards Consortium (CDISC)
• Global, open, multidisciplinary, non-profit
organization initiated in 1997 as a volunteer group
• Incorporated in 2000; now > 170 member
corporations
– Including academic research centers, global
biopharmaceutical companies, technology and service
providers, IRBs….
• Active Coordinating Committees in Europe and
Japan
– Plus 7 User Networks spanning the U.S.
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Integrating the
Healthcare Enterprise
IHE is a collaborative initiative by healthcare professionals and industry to
improve the way computer systems in healthcare share information. IHE
promotes the coordinated use of established standards such as DICOM
and HL7 (and CDISC!).
THE FOUR STEPS OF THE IHE PROCESS
I. Identify Interoperability Problems.
II. Specify Integration Profiles.
III. Test Systems at the Connectathon and Demonstrate at the
Interoperability Showcase at HIMSS.
IV. Publish Integration Statements for use in RFPs.
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Our Use Case
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EDC without data standards,
courtesy Charles Jaffe, MD, PhD
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2/3 of sites have more than one data capture system.
17% have 5 or more!
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50%
40%
32%
30%
24%
20%
20%
17%
10%
7%
0%
eCRF
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Retrieve Form for
Data-capture
• Retrieve Form for Data Capture (RFD), is an IHE
integration profile which enables data capture for
clinical research, drug safety, and other purposes within
an EHR session.
• By collecting two types of data at a single source - the
point of care EHR system--physicians and staff need not
re-enter data into specialized research and surveillance
applications.
• Avoiding redundant data entry reduces data errors and
saves the care provider’s valuable time while allowing
key data to be reported in a timely and accurate manner.
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Problem Focus
• Retrieve form is problem focused:
– Address the multiple data entry systems at sites.
• Retrieve form is experimental :
– Introduce the technique into a site and observe what
happens.
• Retrieve form is developmental:
– Start simple and iterate improvements.
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Start with the Obvious Problem
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Clinical Site
Disease Registry
Entry Form
Clinical Trial
Sponsor
Case Report Form
Public Health Org.
Outbreak Report
Adverse Event
Data
EHR
Safety Org.
•Site
mustengage
engage
•The staff
site staff
with multiple
just one systems.
system: the
•Primary
and secondary
EHR
uses
do nottakes
align.over as
•The EHR
the pivotal data broker
•Primary and secondary
uses of data align
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Retrieve Form for Data-capture
 Archive Form [ITI-d]
Form Filler
Retrieve
Forms
[ITI-a] 
Query Form
Manager
[ITI-b] 
Form Manager
Ex:
Document
Vault
 Submit Form [ITI-c]
Form Receiver
RFD uses the XForms standard to present data capture forms
from external agencies to an EHR.
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Drug
Safety
Clinical
Trial: Lab &
Image Data
Clinical
Trial: Visit
Workflow
Disease
Registry
Sponsored by
Sponsored by
Sponsored by
Sponsored by
BioSurveillance
Sponsored by
RFD Trial Implementation Version
• Approved @ IHE Information Infrastructure
Technical committee, July 2007. Includes
capabilities for data clarification and security.
• Formal testing @ Connectathon 2008
• Content work in Patient Care Coordination
Technical Committee will
– Bind RFD to CDA, ODM, ICSR, CDASH, …
– CDISC’s Terminology project will define code lists
for standard data elements.
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Next Steps: Real World Implementations
• Pfizer: drug safety with Partners - underway
• Eli Lilly: observational trial with Cerner & Quintiles committed
• NIH – Safety Reporting - committed
• Novartis: Images – likely
• Others
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MD Anderson
J&J, Medidata, GE, SAS
AP-HP
Boston Scientific
Genzyme
Parexel
CareSpark
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Parallel Activities
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EHR Vendors’ Association, 30 vendors, organized by HIMSS.
HIT Forum, Suzanne Markel-Fox, GSK and Steve Labkoff, Pfizer.
HIMSS Life Sciences Group, Jeff David.
IMPACC, CIOs’ group within PhRMA. (Will take leadership of HIT Forum.)
EDC task force of bio-stat group (BDM) of PhRMA, Catherine Celignant. White
paper on CDISC web site.
June 13th group: Charlie Saffron of Harvard.
AMIA's Secondary Data Use Group and Clinical Trial workgroup, Charlie Barr.
eHealth Initiative, Janet Marchibroda.
Semantic web life science group of WWW Consortium, Eric Neumann.
EFPIA group in Europe, Isabelle de Zegher, Novartis.
Accenture Slipstream project, John Apathy.
eClinical Forum.
MIT Center for BioMedical Innovation, EHR committee, Hugh Donovan
HL7 RCRIM
Open Group UDEF Health Care Project, Thomas Brunner, Novartis
SAFE
CRIX
OASIS
FDA ePlatform
FDA Sentinel System
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ONLY CONNECT
EHR
CDISC
[email protected]
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