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IT for clinical trials

Development of a new medical device is usually followed by clinical trials with the aim of establishment of the standard operating procedures (SOP) for clinical application of the device. SOP can be established only by performing comprehensive statistical analysis of the data collected during the trials, which is difficult to perform on paper, especially if the trials are carried out at several clinical institutions. Within the ESOPE project of the 5th European Framework we have developed a web-based system for electronic data collection from electrochemotherapy applications performed with the Cliniporator device in four EU countries into a central database. The clinical forms can be filled (Fig. 1), tumor nodules marked on an interactive human map, and tumor data (Fig. 2) and images (Fig. 3) stored and reviewed. Users can also upload the device settings, electrodes properties, and current and voltage measurements from the local Cliniporator databases (Fig. 4). Animated charts (Fig. 5) provide the insight into some basic statistics of the collected data. The Cliniporator manufacturer can also query the central database for the data uploaded from the local databases, and download selected pulse data (Fig. 6).

A thorough statistical analysis of the collected data will provide the guidelines for establishing the SOP for electrochemotherapy with the Cliniporator device. Occasionally, we also upgrade the system with new functionalities, and we are also developing similar systems for other clinical trials.

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