CHALLENGES OF SHARING DATA FROM MEDICAL IMAGING TRIALS
Our five major tasks in GUIDE-IT
There are five major challenges for sharing data from clinical imaging trials which are closely related to the FAIR guiding principles for scientific data management (findability, accessibility, interoperability, and reusability), but are regrouped here in 5 work packages (WP 1-5) to focus on the aspects most relevant for the project.
WP1 - Stakeholder Acceptance
Sharing medical images between different institutions has high potential to advance medical care, but stakeholders, such as patients, participating clinicians and institutions, trial sponsors and policy makers may have relevant concerns which need to be addressed to make these stakeholders accept image sharing.
WP2 - Use and Access
There is a notable cultural change in the medical imaging community towards greater willingness to share data. An important challenge that remains to be solved is the implicit re-identification potential of medical images. Furthermore, intellectual property aspects complicate the situation.
WP3 - Data Quality
Quality of data is key to rendering them suitable and useful for sharing. Meaningful reuse of shared data requires disclosure of all information relevant for interpretation explicitly present in the metadata, i.e., image acquisition parameters, in a commonly understood form.
WP4 - IT Resources
Medical imaging typically creates very large datasets, which are quite heterogeneous compared to more commonly shared genomic data. Furthermore, the nature of imaging data requires large storage and computational capacities that need to be flexible and extensible to incorporate the requisite analysis tools.
WP5 - Sustainability
Due to the large and heterogeneous amount of data, provision of a sharing infrastructure for scientific medical imaging initially requires considerable investment costs. Our intention is to create such an infrastructure for academic use, which requires a model for sustainability. Thus, it is important to consider costs and value beyond the project horizon.
Our Goal
Our intention is thus to create such an infrastructure with a model for sustainability considering costs and value beyond the project horizon. Furthermore, gender aspects and societal and ethical implication will be determined. All concepts will be adjusted to the current national and international developments of interoperable data sharing and the medical informatics initiative to facilitate future affiliation with existing structures. Anticipated Gain of Knowledge: After having completed the pre-project, we will be prepared to enhance the long-term preservation of imaging trials data by setting up an infrastructure project that meets the requirements of the national and international scientific community. A sustainability plan for this infrastructure will be put in place at the host institution to achieve an efficient, accessible, and sustained use of research data from randomised imaging trials which will contribute to scientific discoveries, digital medicine, and improved patient outcomes.
GUIDE-IT Pilot
Currently we are working out a GUIDE-IT pilot to test data sharing with data from the DISCHARGE Trial coordinated by Marc Dewey's team at the Charité with data from the SCOT HEART Trial coordinated by Prof. Dr. Michelle William's team from the University of Edinburgh. Prof. Williams is also Associate Director of the British Heart Foundation Data Science Centre. Both trials investigate the role of coronary computed tomographic angiography for the diagnosis of coronary artery disease and were published in the New England Journal of Medicine (DISCHARGE Trial in NEJM, SCOT HEART Trial in NEJM).