"Making Results of Clinical Studies Comparable"
Interview with Prof. Dr. Markus Löffler on the reasons for and objectives of the BMBF-funded project to develop a national metadata repository in Germany.
Prof. Dr. Markus Löffler
Why do we need a national metadata repository in Germany?
An MDR specifies data elements that are collected in patient-related clinical studies. An extensive database of such data elements helps speed up the development of new concepts for study documentation and assures their quality. Standardized data elements make the results of similar research projects comparable.
How did the project for a German metadata repository arise? How far advanced is the project group with implementation?
In this project, which is funded by the German Federal Ministry of Education and Research, the universities of Leipzig and Munich have been cooperating with TMF since 2009. It is our aim to support the community in developing high-quality data elements and entire core data sets. At present we are working on a software prototype that puts this community scenario into practice.
What are the challenges encountered?
Problems arise from use of the data elements in different research projects, from changes in specification, from local extensions in a project context, in the administration of semantically similar variants, and in mapping between elements. In addition, there is a lack of metrics for the evaluation of quality and processes for harmonization.
What data standards will you be using in the German MDR and why?
Our data model is based on the 3rd edition of the international standard ISO/IEC 11179/3. Import of data elements in the CDISC ODM standard format is implemented. Common medical terminology systems like ICD-10, OPS, MedDRA, TNM, and LOINC can be referenced.
At the TMF workshop in Berlin in September the MDR project group came out in favor of establishing a forum called "Metadata and Linked Data". What does it aim to achieve?
We would like to involve the community more in development in order to ensure the sustainability of the repository. The forum also aims not only to address general issues concerning metadata models and annotations but also to provide space for innovative approaches to semantic technologies and open databases.
Prof. Dr. Markus Löffler is head of the Institute of Medical Informatics, Statistics and Epidemiology at the medical faculty of the University of Leipzig.
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