In clinical trials, images between participating institutions are usually exchanged on CD media that have to conform to the DICOM (Digital Imaging and Communication in Medicine) standard that is internationally used for medical image interchange.
DICOM provides a standardized image file format and communication services for handling medical images. Hence it is used for exchanging medical images for patient treatment in clinical routine as well as for conducting clinical trials in the area of clinical research, e. g. in order to test the effectiveness of new medicaments or for exploring other problems in research and education.
Within each image file, usually name, birth date and further information about the patient and the context of the image acquisition is invisibly stored next to the actual image data. However, DICOM defines policies for protecting the patients privacy in clinical trials (i.e. removing patient identification information from the images), while keeping information required for clinical trial analysis like maybe the age of a patient.
On September 1st 2010, OFFIS has started the new research project “SWABIK”. SWABIK runs for two full years and it is funded by the German Ministry of Research and Education (grant 01 EZ 1023). Its acronym resolves to the German "Software-Werkzeuge für den Austausch von Bilddatenträgern in der klinischen Forschung" which means "Software Tools for the Exchange of DICOM Media in Clinical Research". The project aims at supporting the exchange of medical images on DICOM media to boost efficiency and effectiveness in clinical research. To reach that goal, OFFIS plans to identify best-practice guidelines for handling DICOM media in clinical research and to develop standardized software tools for creating de-identified DICOM CDs and reading such CDs into image archive systems. Furthermore, software tools are being developed in order to check a DICOM CD for errors with the test results being shown in an appropriate format for doctors, nurses or service technicians.
The SWABIK project is supported by the Working Group for Information Technology (AGIT) of the German Society of Radiology (DRG) and by the Coordination Centers for Clinical Trials (KKS Network). These organizations provide OFFIS with knowledge from their practical experiences in conducting clinical trials. Overall, SWABIK is expected to boost effectiveness and efficiency of exchanging medical images in clinical research and particularly in the context of clinical trials.
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