Guide to Data Sharing of Imaging Trials (GUIDE-IT): Pre-Project Concept Phase

• Applicants: Professor Dr. Felix Balzer; Professor Dr. Marc Dewey; Professor Dr. Martin Gersch; Professorin Dr. Dagmar Krefting
• Subject Area: Medical Physics, Biomedical Technology
• Term: since 2022
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 495697118

Background and Objectives: Medical imaging is essential for diagnosis and treatment. Randomized trials of medical imaging are pivotal for advancing medical care. Data from such trials and registries are well structured but rarely shared because they are typically very large and challenging to curate. We suggest addressing these barriers in this pre-project by developing data sharing concepts for improved transparency, reproducibility, patient privacy, and medical guidelines. Enabling data sharing would also be extremely useful for the development of novel imaging biomarkers using artificial intelligence and radiomics. Methods and Work Programme: In the GUIDE-IT pre-project we propose to develop the conceptual basis and requirements for a medicaln imaging trials data sharing infrastructure. We will tackle the following challenges: 1) Stakeholder Acceptance: Sharing medical images between 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. 2) 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 is the implicit re-identification potential of images. Furthermore, intellectual property aspects complicate the situation. 3) Data Quality: Quality of data is key to rendering them suitable and useful for sharing. Meaningful reuse of shared data requires disclosure of metadata information relevant for interpretation. 4) IT Resources: Medical imaging typically creates very large datasets, which are quite heterogeneous. Furthermore, the nature of imaging data requires large storage and computational capacities that need to be flexible and extensible. 5) Sustainability: Due to the large and heterogeneous data, provision of a sharing infrastructure requires considerable investment costs. 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.

• DFG Programme: Research data and software (Scientific Library Services and Information Systems)