Trial Outline Builder

The Trial Outline Builder, TOB, was developed to support clinicians when running clinical trials, especially clinical trials on cancer. It supports designing the trial, data collection when running the trial, and data visualization of the data collected in a trial. The TOB normally runs as a plug-in inside the ObTiMA system (also developed in p-medicine).

TOB is intended for users who are not computer experts. It is a very visual system with direct feedback. The design of the trial layout is done by dragging and dropping medical events (such as radio therapy, randomization, surgery, etc.) from an event repository onto a work board. They can then be dragged around, copied, have their properties edited, etc. by simple interaction. The interface was developed with repeated feedback from clinicians, and is intended to mimic the way they usually work, to be intuitive and to have a low barrier to entry.

When designing a trial you also attach data input forms to the events in the trial, and when running a trial it is easy to open the appropriate input forms just by clicking on the events in the patients treatment plan. This helps with improving the quality of the data collected in the trial, avoiding misspelled data input or changing the data in the wrong input form when there are several input forms of the same type for the same patient (e.g. when receiving several cycles of chemo therapy).

The interface is consistent throughout all phases of a trial, so the events and the trial outline look the same when running the trial and collecting data as they did during the design phase. After the trial is finished, the system also supports visualization of the collected data.

The system can easily show differences between different groups of patients and allows many types of visualization and data mining.

Changing the grouping of patients or removing subsets of patients immediately and automatically updates all the visualizations on screen, which allows experts to explore the data interactively.

The TOB is built using “meme media”, a framework of pluggable software components, a kind of intelligent software objects. Meme media is intended to make sharing and reuse of services and functionality as easy as sharing and reuse of data resources such as text and images is with standard technology now. This makes it easy to add new functionality to the TOB, and to test out new ideas that clinicians think could be useful.

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