Medical imaging research often involves interdisciplinary teams, each performing a separate task, from acquiring datasets to analyzing the processing results. The number and size of the datasets continue to increase every year due to continued advancements in technology. We support federated imaging archives with a variety of informatics services (software tools) that facilitate the development and evaluation of new candidate products. This public resource might be accessed by developers at various stages of their development cycle. Some may need to access the scans and data at the outset of their development process, whereas other innovators might have access to internal resources and need to access this resource later in their cycle to document performance.
The BSB describes public resources for methods and services that may be used for the assessment of imaging biomarkers that are needed to advance the field. It sets out the problem space and the goal for these informatics services. Specifically, sections are included to address the following topics:
- background on regulatory and biomedical concepts that comprise the key areas for the areas we are exploring,
- identify the initial focus on selected test bed applications,
- identify how this relates to activities in modeling business logic and analyzing the domain in terms of data abstractions to provide a basis on which the development will proceed.
A core concept is the "Reference Data Set." This is intended to include both images and non-imaging data that are useful in either the development or performance assessment of a given imaging biomarker and/or specific tests for that biomarker. A given biomarker must have at least one test that is understood to measure it, but in general there may be many tests that are either perceived or in fact measure the biomarker at various level of proficiency. The utility of a biomarker is defined in terms of its practical value in regulatory and/or clinical decision making, and the performance of a test for that biomarker is defined in terms of the accuracy with which it measures the biomarker. This gives rise to a high-level representation of workflows defined for this area.
The EUC describes public resources for methods and services that may be used for the assessment of imaging biomarkers that are needed to advance the field. It sets out the workflows that are derived the problem space and the goal for these informatics services as described in the Basic Story Board.
The system use cases desacribe the principal workflows which have been identified. The sequence in which they are presented is set up to draw attention to the fact that each category of workflows builds on others. As such, it forms a rough chronology as to what users do with a given biomarker over time, and may also be useful to guide the design in such a way as it may be implemented and staged efficiently.
The Laboratory Protocol provides user-level instructions on how to use the pieces. It is constructed so as to allow the analyses to provide a high level of traceability for provenance and reproducibility of results.