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
