healthcare link initiatives: bridging clinical research and healthcare may 29, 2008 bay area...
TRANSCRIPT
Healthcare Link Initiatives: Bridging Clinical Research and Healthcare
May 29, 2008Bay Area Users’ GroupLanden BainCDISC Liaison to Healthcare
2
NIH / DCRICDASH
Data Collection Stds(FDA Critical Path) • Integration Profile
• Healthcare Link DemoCV/ TB Data Stds
Terminology
WHO International Clinical Trial Registry Platform
• Submission Standards• Protocol Representation• Critical Path Initiative
• Liaison Status to ISO/TAG215• Submitted CDISC Standard as New Work Item
• Protocol Representation w/ elements mapped to EudraCT• Discussing all CDISC projects
BRIDG
PhRMA
EFPIA
• Shared Information• Business Case• CDASH• IA Project• eSubmissions
3
Healthcare Link Relationships
4
Circa 1998 …..
autoreconciliation
dataconception
(e)CRFs(e)Source
DocumentsEHR
eSourceHealthcare Delivery
Clinical Research
5
Patient CarePatient CareWorldWorld
Clinical ResearchClinical ResearchWorldWorldSingle Source 2003
An industry initiative that has successfully demonstrated clinical information interoperability between physician clinical systems (EHR) and pharmaceutical clinical trials systems based on open standards.
-Duke Medical Center, Duke Clinical Research Institute, CDISC, Novartis, Merck, J&J, Microsoft
JAMIA article to be published.
6
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 PROCESSI. 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.
7
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.
1. Identify Interoperability Problem
8
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 PROCESSI. 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.
2. Specify Integration Profiles
Retrieve Form for Data Capture
9
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 PROCESSI. 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.
3. Test Systems at the Connectathon and Demonstrate at the HIMSS Interoperability Showcase.
11
12
Healthcare Link Technology
13
Medical Research
Healthcare Link
Healthcare
Form Filler
DataArchiver
FormManager
Data Receiver
RFD’s Four Actors enable:• Visual integration of eCRF into the EHR• Creation of an eSource document independent of the EHR• Integration of workflow while maintaining separation of data
EHR
Protocol
14
ASTER is mentioned twice:
p. 7 & p. 20
p. 7, note 12: “CDISC has developed a tool that converts source data from a clinical information system to a format that can be transmitted to regulatory authorities to report clinical trial adverse events. “
Current paper-based practice.
How RFD mimics the paper flow.
Physician/investigator photo-copies a page out of medical record, eyeballs it, edits it, derives needed data for submission, and files it as a
paper source document. The chain of custody is severed at that point, and the source is now the paper copy, not the original from the paper
chart.
Form Filler
Form Mgr
3. Form with ‘photocopy’ of EHR data returned to EHR
2. Form Mgr ‘pastes’ the ‘photocopy’ into the form.
4. Investigator eyeballs form, verifies copy, edits, submits
data, and saves as eSource,
cutting chain of custody.
Healthcare Research
1. Electronic ‘photocopy’ of a medical summary
(CCD) routed to Form Mgr
16
Retrieve Form Transaction
IHE Grouping Model: Bind content creators and consumers to a single integration profile transaction
Content Profile: Clinical Trial Data
Integration Profile: RFD
Form Manager
Content Consumer
Standard CRF
ODM/CDASH
Mapping
CCD In CDASHOut
Content Creator
HL7 CDA Medical Summary (CCD)
Form Filler
17
RFD: A Disruptive Innovation“Two paradigmatic trajectories of progress interact.”
http://www.12manage.com/methods_christensen_disruptive_innovation.html