SECURE PROCESSING OF IMAGE DATA IN CLINICAL STUDIES
The German Heart Center Berlin (Deutsches Herzzentrum Berlin, DHZB) is one of the world's largest heart centers and is a leading research center with numerous international partners. In addition to innovations in the field of surgical and cardiac catheter-based procedures, an important research focus at DHZB is non-invasive multimodal imaging. In the Europe-wide Cardioproof trial, the heart center relies on TrialComplete to provide effective processes for implementing the study content. The web-based TrialComplete trial portal enables researchers at the participating study centers to enter and analyze trial and image data, and to carry out quality assurance regardless of their location. With the operation hosted in Deutsche Telekom data centers, access to the portal is easy and secure for everyone involved, while a professional team takes care of data protection. In overview, the capabilities include:
- A study platform with integrated image data management
- Web-based solution also enables decentralized execution of the trials
- Operation on the Dynamic Healthcare Center Platform (DHC) in Germany
- A freely scalable system whereby, for example, costs can be calculated according to the number of subjects and the duration of the trial
The German Heart Center Berlin was founded in 1986 as a foundation under civil law. In its statutes, the DHZB has set itself the goal of "... delivering outstanding quality services in the field of cardiac surgery and cardiology medicine and ensuring state-of-the-art treatments". Up to 3,500 open heart operations are performed annually using the heart-lung machine. In addition, more than 4,000 cardiac catheter examinations are carried out annually in the three cardiac catheter laboratories. More than 2,000 of these are interventions, some of which are highly complex, for example, the replacement of a heart valve using catheter technology. Two high-performance magnetic resonance tomograph systems, a computer-assisted tomography scanner and a large number of the most modern echocardiography systems are available for non-invasive special diagnostics. Another important focus at DHZB is congenital heart defects, in which patients of all age groups - from newborns to seniors - are treated. Each year, 400 operations and around 700 cardiac catheter examinations are performed at the Clinic for Congenital Heart Defects/Pediatric Cardiology, which place it in the absolute top group in Germany and Europe. The German Heart Center Berlin has an extensive national and international collaborative network. There are now over 50 cooperation agreements and related agreements with heart clinics in Germany and abroad, mainly in China, but also in Eastern Europe and the Asia-Pacific region.
"The TrialComplete portal solution is readily set up, scalable to individual requirements and easy to use - this considerably simplifies trial management, and enables me to devote myself more to content-related topics.”
Prof. Dr. Titus Kühne, German Heart Center Berlin
As a top medical center with international cooperation partners, the DHZB carries out a wide range of research activities, has a broad scientific base, and covers the entire spectrum of diagnostic and therapeutic procedures. The increasing importance and further development of imaging is a strong focus at the Center. Non-invasive imaging methods, as used in the EU Cardioproof trial, are an important cornerstone. The Cardioproof trial is coordinated by the DHZB and takes place with the participation of study center partners from England, France, Italy, and Austria. The Cardioproof trial examines innovative imaging and analysis technologies, with the image data passing through a variety of paths from the survey center to assessment. A central concern is to ensure that after the initial assignment to the test person, the image data are further processed reliably in their proper context without media disruptions, so that the linkage of the image data to the test participants is retained at all times. A further challenge was to have a solution that can adequately record, process and make decentralized image data available, enabling an easy and secure data exchange.
TrialComplete is a platform for image-based clinical studies with the necessary functionalities such as role and rights concepts, and audit trails. It provides for the ready mapping of a study design onto the user interface. TrialComplete also records the image material and integrates it into the study in the right context with seamless data processing. Well-engineered “split” and “merge” functions offer the possibility of processing even complex image data sets in a way that is appropriate for the application before they are released for further use by an expert. TrialComplete is able to record DICOM data from a wide variety of modalities and manufacturers, to view and measure them in the integrated DICOM viewer. The image data is reliably available in context for subsequent use even after the trial is concluded. The use of TrialComplete on a "Software as a Service” basis, hosted in the highly secure Deutsche Telekom data centers in Frankfurt, also relieves the DHZB of complex network adaptations that would be required for a secure image data exchange between the external partners involved if each were operating its own data center.
TrialComplete provides the German Heart Center Berlin with an infrastructure for its Cardioproof trial that effectively supports the course of the study. First of all, the simple implementation of the study design offers the option of intensive testing under actual conditions prior to productive use. Image data can be recorded in the survey center during the course of the study, linked to the respective test subject session, and stored. A central quality assurance function releases the image data before it is assessed in other centers, either with an integrated viewer or as an export in specific, partially experimental software systems, and the result is stored in TrialComplete in the proper context. Not only is the entire study process documented consistently in a single system, but also in a way that the image documents that are part of the trial are integrated. This means that the relationship between image data and other study data is retained even after the study has been completed. Both types of data are available for reuse, so that additional knowledge can be generated with little effort.