IT & Data sharing
PCM Task force Chair: Michele Masucci
The objective is to collect and disseminate information on ongoing developments within data sharing and informatics for PCM, both on a local level and in a broader international context. The purposes are to monitor, facilitate and engage in projects that forward the capacity for data collection, analysis and visualization within the context of clinical PCM trials.
Completed activities and achieved results
Development and implementation of an online decision support platform, an MTB-portal, for molecular profiling, used during weekly tumor boards for inclusion of patients to the CCE BoB clinical trial. A public version of the tool that does not collect patient data has been made available. Comment in Nature Medicine are published with main author David Tamborero.
Local startup of a CCE initiated cohort study of BRCA 1 and 2 somatically mutated pan-cancer patients. The purpose was to test data sharing methods for CCE. The project has been discontinued in 2023.
Survey of the necessary process and requirements for ISO certification and CE licensing of software used in a routine clinical setting. The process for certification and adherence to IVDR of tools developed within research that will reach clinical settings and are classified as medical devices has been initiated. The work is being conducted by Karolinska University Hospital in assistance by external consultants and PCMs support.
Future planning
Further dissemination of the MTB-portal and iPCM related software in a local and international contexts. Coordination with planned PCM clinical trials in the local context that could make use of the MTB portal and other IT infrastructure and software output from ongoing research projects. Set up of local data collection infrastructure of clinical data and molecular diagnostics data to serve local projects and trials.
Engagement and local implementation of the Virtual Data Centre pillar in the Cancer Core Europe consortium. This comprises comprehensive work on Ks and Stockholm regions resources, methods, interfaces and data infrastructures to facilitate translational research. The VDC is proposed to be a use case for this growing capacity and need. In 2024 substantial progress is projected with concrete data variables identified and an existing funding opportunity that might facilitate the project at a local level.
Information and advice to local PCM researchers on the data infrastructure.
Regular focus groups with end users to continuously survey needs within PCM research and match with existing solutions and role models globally. Disseminate results to key decision makers.
Continuous participation and work with the CCE efforts in data sharing.
Production of tutorial for researchers on legal, ethical and technical aspects of PCM.
