Web-based electronic data collection system to support electrochemotherapy clinical trial.

Many branches of the healthcare industry are being influenced by information and communication technology (ICT). Clinical trials are not an exception. Despite this fact, more than 75% of clinical trials data are being collected on paper records. Recent ICT advances, such as broad acceptance of Internet Technology which are rapidly improving electronic data collection (EDC) tools, however, may soon reduce this percentage of "paper" supported clinical trials. In this paper, we present our Web-based EDC system designed to support a small-scale research-oriented clinical trial for establishing standard operating procedures (SOP) for electrochemotherapy with a new medical device, named Cliniporator. The definition of the SOP can only be based on a comprehensive analysis of collected data and results of clinical trial. Therefore, it is necessary to record treatment efficiency and, in this respect, to carefully follow and collect treatment parameters. We thus established central database and the Web application for filling database with data submitted by users from distant medical centers across Europe. Also, we enabled transmitting of data stored on the local Cliniporator medical devices to the central database as well as submitting of tumor images and marking of tumor nodules on interactive human map developed in Macromedia Flash. We provided users with dynamically generated basic statistics, and, several times during data collection process, we performed statistical data analysis. In order to assure high quality of data in a database, we included several mechanisms: automatic data validation, digital signatures, the form completeness notification system, e-mail alerting of completed forms, and "check tables." After 13 months of using the systems, we performed a simple usability evaluation of the system by asking users to answer to a questionnaire, and here we present the results. With this paper, we try to share our experience and encourage others to exploit Internet and Web technologies to improve clinical trials data collection, follow up, and data analysis.