Future Developments of Medical Informatics from the Viewpoint of Networked Clinical Research

Summary

Objectives: To be prepared for future developments, such as enabling support of rapid innovation transfer and personalized medicine concepts, interoperability of basic research, clinical research and medical care is essential. It is the objective of our paper to give an overview of developments, indicate problem areas and to specify future requirements.

Methods: In this paper recent and ongoing large-scaled activities related to interoper-ability and integration of networked clinical research are described and evaluated. The following main topics are covered: necessity for general IT-conception, open source/open community approach, acceptance of eSource in clinical research, interoperability of the electronic health record and electronic data capture and harmonization and bridging of standards for technical and semantic inter-operability.

Results: National infrastructures and programmes have been set up to provide general IT-conceptions to guide planning and development of software tools (e.g. TMF, ca BIG, NIHR). The concept of open research described by transparency achieved through open access, open data, open communication and open source software is becoming more and more important in clinical research infrastructure development (e.g. ca BIG, ePCRN). Meanwhile visions and rules for using eSource in clinical research are available, with the potential to improve interoperability between the electronic health record and electronic data capture (e.g. CDISC e SDI, eClinical Forum/PhRMA EDC/eSource Taskforce). Several groups have formulated user requirements, use cases and technical frameworks to advance these issues (e.g. NHIN Slipstream-project, EHR/CR-project, IHE). In order to achieve technical and semantic interoperability, existing standards (e.g. CDISC) have to be harmonized and bridged. Major consortia have been formed to provide semantical inter-operability (e.g. HL7 RCRIM under joint leadership of HL7, CDISC and FDA, or BRIDG covering CDISC, HL7, FDA, NCI) and to provide core sets of data collection fields (CDASH).

Conclusions: The essential tasks for medical informatics within the next ten years will now be the development and implementation of encompassing IT conceptions, strong support of the open community and open source approach, the acceptance of eSource in clinical research, the uncompromising continuity of standardization and bridging of technical standards and the widespread use of electronic health record systems.

Keywords

Interoperability - open source - eSource - electronic health record - electronic data capture - standards - CDISC - caBIG - HL7

• References

• 1 Turisco F, Keogh D, Stubbs C, Glaser J, Crowley JWF. Current status of integrating information technologies into the clinical research enterprise within US academic health centers: strategic value and opportunities for investment. J Investig Med 2005; 53 (08) 425-433.
• 2 TMF.. Telematikplattform für Medizinische Forschungsnetze e. V. (TMF) (accessed: September 23, 2008). Available from:. http://www.tmf-ev.de/Home.aspx
• 3 National Cancer Institute.. The caBIG^M Pilot Phase Report: 2003-2007. (accessed: September 23, 2008). Available from: http://cabig.cancer.gov/resources/report.asp
• 4 e PCRN.. Electronic Primary Care Research Network (ePCRN). (assessed: September 23, 2008). Available from: http://www.epcrn.bham.ac.uk
• 5 Electronic Source Data Interchange Group.. Leveraging the CDISC Standards to Facilitate the use of Electronic Source Data within Clinical Trials (accessed: September 23, 2008). Available from: http://www.ehealthinformation.ca/documents/eSDIv05.pdf
• 6 GCP Inspectors Working Group.. Reflection paper on expectations for electronic source documents used in clinical trials. European Medicines Agency (accessed: September 23, 2008). Available from: http://www.emea.europa.eu/Inspections/docs/50562007en.pdf
• 7 The eClinical Forum and PhRMA EDC/eSource Taskforce.. The Future Vision of Electronic Health Records as eSource for Clinical Research (accessed: September 23, 2008). Available from: http://www.esi-bethesda.com/ncrrworkshops/clinical/Research/pdf/CatherineCeligrantPaper.pdf
• 8 Kush R, Alschuler L, Ruggeri R, Cassells S, Gupta N, Bain L. et al. Implementing Single Source: the STARBRITE proof-of-concept study. J Am Med Inform Assoc 2007; 14 (05) 662-673.
• 9 NHIN Slipstream Project.. Use Case for Connecting Patients to Clinical Trials Using Electronic Health Records (accessed: September 23, 2008). Available from: http://www.eurorec.org/EHRWorkshop/prereads/NHIHN%20Slipstream%20Use%20Case%20for%20connecting%20Patients%20to%20Trials%20using%20EHR.pdf
• 10 NHIN Slipstream Project.. Use Case for Medical Product Safety Surveillance Using Electronic Health Records (accessed: September 23, 2008). Available from: http://www.eurorec.org/EHR/Workshop/prereads/NHIN%20Slipstream%20Use%20Case%20for%20Medical%20Product%20Safety%20Surveillance%20using%20EHR.pdf
• 11 EHR/CR Functional Profile Working Group.. Electronic Health Records/Clinical Research: EHR/CR User Requirements Document. PhRMA EDC/ eSource Task Force (accessed: September 23, 2008). Available from: http://www.eurorec.org/ehrworkshop2/research/EHR-CR%20User%20Requirements%20Document%20Release%201.pdf
• 12 EHR/CR Functional Profile Working Group.. Electronic Health Records/Clinical Research: EHR/CR Functional Profile. HL7 EHR Technical Committee Liaison (accessed: September 23, 2008). Available from: http://www.eurorec.org/ehrworkshop2/research/HL7%20EHRCR%20Functional%20Profile%20Rel%201.pdf
• 13 Siegel EL, Channin DS. Integrating the Healthcare Enterprise: a primer. Part 1. Introduction. Radio-graphics 2001; 21 (05) 1339-1341.
• 14 Channin DS. Integrating the Healthcare Enterprise: a primer. Part 2. Seven brides for seven brothers: the IHE integration profiles. Radiographics 2001; 21 (05) 1343-1350.
• 15 IHE International.. Welcome to Integrating the Healthcare Enterprise (accessed: September 23, 2008). Available from: http://www.ihe.net
• 16 ACC/HIMSS/RSNA.. IHE IT Infrastructure Technical Framework Supplement 2007-2008 (accessed: September 23, 2008). Available from: http://www.ihe.net/Technical_Framework/upload/IHE_ITI_TF_Supplement_Appendix_V_TI_2007_08_15.pdf
• 17 Business Wire.. CDISC Showcases Interoperability Prototype between Medical Research and Health-care. Business Wire (accessed: September 23, 2008). Available from: http://www.thefreelibrary.com/CDISC+Showcases+Interoperability+Prototype+between+Medical+Research...-a0161797466.
• 18 The Innovative Medicine Initiative.. Creating Biomedical R&D Leadership for Europe to Benefit Patients and Society. The Innovative Medicine Initiative (accessed: September 23, 2008). Available from: http://imi.europa.eu/docs/imi-gb-006v2–15022008-research-agenda_en.pdf
• 19 Innovative Medicines Initiative.. Innovative Medicines Initiative Joint Undertaking (accessed: September 23, 2008). Available from: http://www.imieurope.org/Pages/default.aspx
• 20 Kush R. CDISC & the World of Health Information Technology. Applied Clinical Trials 2007 (accessed: September 23, 2008). Available from: http://appliedclinicaltrialsonline.findphama.com/appliedclinicaltrials/IT+Articles/CDISC-amp-the-World-of-Health-Information-Technolo/ArticleStandard/Article/detail/401625?contextCategoryId=44910.
• 21 CDISC.. Clinical Data Interchange Standards Consortium (CDISC) (accessed: September 23, 2008). Available from: http://www.cdisc.org
• 22 Souza T, Kush R, Evans JP. Global clinical data interchange standards are here!. Drug Discov Today 2007; 12 (3-4): 174-181.
• 23 HL7.. Health Level Sevel (HL7) (accessed: September 23, 2008). Available from: http://www.hl7.org
• 24 openEHR (accessed: September 23, 2008). Available from: http://www.openehr.org/home.html
• 25 Electronic Health Record Communication (EHRcom).. EHRcom – EN 13606 – Parts 1 and 4 now officially approved as European Standards (accessed: September 23, 2008). Available from: http://www.eurorec.org/services/EHMcom%20-%20EN%2013606.rtf
• 26 Weng C, Gennari JH, Fridsma DB. User-centered semantic harmonization: a case study. J Biomed Inform 2007; 40 (03) 353-364.
• 27 BRIDG.. Biomedical Research Integrated Domain Group (BRIDG) (accessed: September 23, 2008). Available from: https://cabig.nci.nih.gov/inventory/infrastructure/bridg
• 28 CDISC CDASH Team.. Clinical Data Acquisition. Standards Harmonization: Basic Data Collection Fields for case Report Forms (accessed: September 23, 2008). Available from: http://www.cdisc.org/standards/cdash/downloads/CDASH_Draft_Post_Version.pdf
• 29 Ohmann C, Kuchinke W. Meeting the challenges of patient recruitment: A role for electronic health records. Intern J Pharm Med 2007; 21: 263-270.