prof. dr. c. ohmann coordination centre for clinical trials (ccct) heinrich-heine-university...
TRANSCRIPT
Prof. Dr. C. OhmannCoordination Centre for Clinical Trials
(CCCT)Heinrich-Heine-University
Düsseldorf, Germany
Primary and secondary use of EHR:Enhancing clinical research11 October 2007, Brussels
Data interoperability – short term practical solutions:
IT perspective
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Prof. Dr. C. Ohmann, CCCT
Data interoperability – short term practical solutions : IT perspective
- aim of the presentation -
differences between medical care and clinical research
status of interoperability
benefits/challenges of interoperability
models and standards for data interoperability
examples of data interoperability
summary
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: different worlds
different targets
different regulations
different processes, actors, roles
different ontologies, classifications,
terminologies
different and distributed databases
different software solutions
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: different worlds
medical care
EHRbasic
research
clinical research
HL7 XDT DICOM
ICD OPS MeSH
....
CDISC SAS
MedDRA LOINC SNOMED ....
BSML MAGE-HL XMLgene
HGNC GO MGED ....
EHR and clinical research: current status of interoperability*
*Turisco et al., J Investig Med 2005; 53: 425-433
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: promising examples
single source project (CDISC/HL7)
centralized clinical research data warehouses- Mayo Clinic: Life Science System-IBM- Partners Health Care: University of Pittsburgh‘s Medical Archival System- Information Warehouse of Ohio State University Medical Center- Mount Sinai‘s General Medicine Outpatient database- etc.
Siemens Medical Solutions (TU Munich)
support of patient recruitment in clinical trials- Mayo Clinical System- Kaiser EHR System health connect
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: support of patient recruitment*
„Integrating EHRs with clinical trials has major potential to increase recruitment rate,
as could be demonstrated in first studies“
*Ohmann, Kuchinke:Meeting the challenges of patient recruitment. A role for electronic health records.Int J Pharm Med 2007; 21: 263-270
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: support of patient recruitment by a clinical trial alert system*
*Embi et al., Arch Intern Med 2005;165:2272-2277
parameter Clincal Trial Alert System
before after
no. of referrals (per month)
no. of enrollments (per month)
5.7
2.9
59.5
6.0
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: benefits of interoperability
similar needs and goals of healthcare industry and biopharmaceutical industry
improve patient safety and access to treatment
reduce costs for clinical trials(reduce redundant data entry, queries, source data
verification)
speed up trials by improving patient recruitment with access to clinical data
improve workflow and increase quality of clinical trials(e.g. reduce data transcription errors, improve
timeliness of data, facilitate information flow, increase personnel efficiency)
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: requirements/challenges
harmonisation of standards between health care and research
(common data standards, data transfer standards, standard interfaces, etc.)
common regulations and guidelines for privacy, security, record integrating
cooperation between biopharmaceutical and healthcare industries, between EDC and EHR System vendors
modification of regulatory guidelines to support the use of eSource
application of FDA 21 CFR part 11 and other rules/regulations fo EHR
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Prof. Dr. C. Ohmann, CCCT
investigator final report
monitor sponsorstudy manager data manager
integration
queries
Database
study software
Clinical research: flow of information and user rolesClinical research: flow of information and user roles
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Prof. Dr. C. Ohmann, CCCT
EC 2001/ 20/ EG Guideline (04.04.2001) EC 2005/28/EC Guideline (084.04.2005) Arzneimittelgesetz (12. Gesetz zur Änderung des AMG vom 06.08.2004) ICH E6: Good Clinical Practice (Mai 1996) ICH E9: Statistical Principles for Clinical Trials FDA 21 CFR Part 11: Electronic Records: Electronic Signatures (March 1997) FDA Guidance for Industry: Computerised Systems used in Clinical Trials (April 1999) Annex 11 – European Commission Directive
2003/ 94/ EC
Clinical research: regulatory requirementsClinical research: regulatory requirements
Industry standard:
GAMP Guide for the Validation of Automated Systems, Version 4
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Prof. Dr. C. Ohmann, CCCT
Technologies to capture clinical trial data*
Paper Medical Record Case Report Form (CRF)
- Paper CRF- eCRF
- Thin (Web Browser) Client- Thick Client
Diaries- Paper Diary- eDiary
- Connected System- Semi Connected System- Disconnected System
Electronic Health Records- Printed Records from an Electronic Health Record
(EHR) system- EHR System Used to Capture CRF Data
*CDISC Electronic Source Data Interchange Group:Leveraging the CDISC standards to facilitate the use of electronic source data within clinical trials, 2006
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: BRIDG*
A clinical research domain analysis model (UML) bridging organisations (CDISC, HL7, FDA, NCI) standards research and healthcare (CDISC and HL7)semantic foundation for application and message development in HL7, caBIG and CDISC
*Biomedical Research Integrated Domain Group (BRIDG) Model
http://www.bridgproject.org
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: HL7/IHE
Health Level 7 (HL7)
regulated Clinical Research Information Management (RCRIM)Technical Committee
(focus on standards that involve clinical research liaison to CDISC) version 3 based on Referenz Information Model (RIM) HL7 Clinical Document Architecture (CDA)
(exchange model for clinical documents)
Integrating the Healthcare Enterprise (IHE)
technical framework for implementation ofestablished messaging standards (e.g. HL7)
specification of Integration Profiles based onactors that interact through transactions
Integrated Profile „Refrieve Form for Data Capture (RFD)“
(gathering data with a user‘s current application to meet the requirements of an external system)
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Prof. Dr. C. Ohmann, CCCT
EHR and clinical research: solutions for interoperability
recording care data with EDC system and transfer to EHR
local site system with copy to EDC/EH
incorporation of EDC into EHR
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Prof. Dr. C. Ohmann, CCCT
The vision: EHR and electronic clinical research data capture*
*eClinical Forum and PhRMA EDC/eSource Taskforce:The future vision of electronic health records as
eSource for Clinical Research, Vers. 1.0, 2006
EHR and clinical research: - “single source project”*
*Kush et al., Implementing Single Source: The STARBRITE Proof-of-Concept Study. JAMIA 2007; 14:662-673
increasing efficiency in clinical research with an integrated trial platform based on
electronic and integrated data acquisition / management
optimized processes and information flows integrating clinical practice and clinical research.
Benefits for the Medical Center:
All data are electronically available, fast availablity
Research data are integrated High-quality data Adapted to workflow of users Standardization of internal processes Transparency Data security considers high efficiency Attractive for external Sponsors
Benefits for external sponsors:
All data electronical with Audit Trail Verifable quality High satisfaction of users
TUM
HIS
PACS
Clinical Routine
Processes
Clinical Research
Processes
Lab
Mapping/ Filtering
IntegrationEngine
Validation Buffer
Research-Portal = User Interface
EDC
Research
DB
Non-Image-Data Image-Data
External Center
Oct - 07 Siemens Medical SolutionsCopyright © Siemens AG 2007. All rights reserved.
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Prof. Dr. C. Ohmann, CCCT
Data interoperability – short term practical solutions: IT-perspective
- summary/ conclusions -
major differences between health care and clinical research
data interoperability of EHR and EDC rarely implemented
major benefits but demanding requirements/challenges for interoperability
systematic approaches for data interoperability between EHR and EDC available/under development and promising show-cases/proof-of-concept studies performed
major activities and ressources needed in the near future to come to practical solutions working in routine