Healthcare Link Initiatives: Bridging Clinical Research and Healthcare

May 29, 2008Bay Area Users’ GroupLanden BainCDISC Liaison to Healthcare

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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

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Healthcare Link Relationships

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Circa 1998 …..

autoreconciliation

dataconception

(e)CRFs(e)Source

DocumentsEHR

eSourceHealthcare Delivery

Clinical Research

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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.

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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 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.

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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.

1. Identify Interoperability Problem

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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 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

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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 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.

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Healthcare Link Technology

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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

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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

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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

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RFD: A Disruptive Innovation“Two paradigmatic trajectories of progress interact.”

http://www.12manage.com/methods_christensen_disruptive_innovation.html

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lbain@cdisc.org

Strength through collaboration.