The DZHK is organized in a decentralized way. It is made up of 32 partner institutions at seven locations that have a high level of autonomy in their research. They cover the whole spectrum of cardiovascular research and therefore achieve a high standard by international comparison. The partner institutions include 14 universities/university clinics, as well as centers from the Helmholtz Association, Leibniz and Max Planck Institutes and a departmental research institute. In this way, the DZHK combines the work of over 1,800 scientists under one roof and creates synergy effects. A central step for the translation and transfer of results from basic research to application are reliable, high-quality, and well-documented clinical studies. For this, the DZHK relies on TrialComplete as an important component in its system landscape.
TrialComplete is a professional, modern tool we can use to capture clinical image data across locations and make it readily available for research.
With TrialComplete, the DZHK has a professional system to support clinical trials. Scientists can work quickly and easily with the image data they need. Audits are no problem: the data is collected in the standard way for a trial via project-specific electronic case report forms. This ensures the classification and therefore the results are reproducible. Above all, TrialComplete supports collaboration across different locations.
A differentiated roles and rights concept makes the relevant results and raw data (including that of other network participants) available to connected research institutes in a simple and targeted way. New research projects can be created with ease anytime and can be supported with comprehensive functionalities. Now in 2021, the platform is also showing benefits for Covid-19 research: on behalf of the national research network of university medicine (NUM), medical images are captured from 11,000 test subjects for three cohorts that should provide information on the long-term effects of Covid-19 illnesses. The data can also be used for authorized questioning beyond the scope of individual studies.
Progress in research requires reproducible data. And the need for data is always growing: cardiovascular research in particular requires continually larger studies, patient records and biobanks to make further progress. There are specific rules that research institutes need to follow to participate in clinical studies: for example, participants need to hold their trial results over a time period of 10 years in a clear and transparent format. For this, data from numerous sources, including patient, clinic, imaging, and trial data are combined, all whilst complying with data protection requirements.
This is a particular challenge in research projects distributed across different locations: different documentation and archives (including analog) are used in different systems. This is a particular challenge in research projects distributed across different locations: different documentation and archives (including analog) are used in different systems. Critical points include the anonymization of image material and media disruptions caused by distributed teams. The employees working on the trials are often only employed for the duration of the trial, meaning, in the worst case, documents or receipts end up in drawers or on shelves. This hinders the work of the scientists and the future reproducibility of the trial results. In 2017, with its federal structure, the DZHK decided to solve the essence of these challenges: using its professional image data management system for professional research that can be used across locations.
The DZHK chose TrialComplete, developed by Deutsche Telekom Healthcare Solutions. The solution supports the whole trial process from beginning to end. It allows anonymization and archiving of medical and image data in standardized data formats (e.g. DICOM, CDISC ODM). The image data are therefore saved in a central location. All authorized scientists have access to a standardized and consolidated database. As the solution is provided as a web application, no installations are required at the sites.
The application and image data are made available by secure and mirrored German data centers from Deutsche Telekom that comply with data protection regulations. The scientists access TrialComplete as a client using internal institute computers. TrialComplete scales up according to requirements. If multiple researchers access the system simultaneously, further resources are made available to maintain performance. The storage grows with the continually increasing volume of data. At the same time, Deutsche Telekom Healthcare Solutions embedded TrialComplete into the existing system landscape of the DZHK to facilitate consolidated work across different resources.
