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WEB-BASED SYSTEMS FOR CLINICAL TRIALS DATA COLLECTION
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).
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.
- Pavlovic I, Kramar P, Corovic S, Cukjati D,
Miklavcic D. A web-application that
extends functionality of medical device for tumor treatment by
means of electrochemotherapy. Radiol.
Oncol. 38: 49-54, 2004. [PDF]
- Pavlovic I, Kramar P, Corovic S, Cukjati D, Miklavcic D.
The web-based medical record system to support clinical
trials. Proceedings of the IEEE 12th Mediterranean
Electrotechnical Conference MELECON 2004, Dubrovnik, Croatia,
12-15 May, 2004.
- Pavlovic I. Web-based medical
record system for clinical trials. M.S. thesis, Faculty of
Electrical Engineering, University of Ljubljana, 2004.