Web-based electronic data collection system to support electrochemotherapy clinical trial. 2007

Ivan Pavlović, and Damijan Miklavcic
Faculty of Electrical Engineering, University of Ljubljana, SI-1000 Ljubljana, Slovenia. ivan@lbk.fe.uni-lj.si

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.

UI MeSH Term Description Entries
D009369 Neoplasms New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms. Benign Neoplasm,Cancer,Malignant Neoplasm,Tumor,Tumors,Benign Neoplasms,Malignancy,Malignant Neoplasms,Neoplasia,Neoplasm,Neoplasms, Benign,Cancers,Malignancies,Neoplasias,Neoplasm, Benign,Neoplasm, Malignant,Neoplasms, Malignant
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D003628 Database Management Systems Software designed to store, manipulate, manage, and control data for specific uses. Data Base Management Systems,Management System, Data Base,Management Systems, Data Base,System, Data Base Management,Systems, Data Base Management,Database Management System
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000970 Antineoplastic Agents Substances that inhibit or prevent the proliferation of NEOPLASMS. Anticancer Agent,Antineoplastic,Antineoplastic Agent,Antineoplastic Drug,Antitumor Agent,Antitumor Drug,Cancer Chemotherapy Agent,Cancer Chemotherapy Drug,Anticancer Agents,Antineoplastic Drugs,Antineoplastics,Antitumor Agents,Antitumor Drugs,Cancer Chemotherapy Agents,Cancer Chemotherapy Drugs,Chemotherapeutic Anticancer Agents,Chemotherapeutic Anticancer Drug,Agent, Anticancer,Agent, Antineoplastic,Agent, Antitumor,Agent, Cancer Chemotherapy,Agents, Anticancer,Agents, Antineoplastic,Agents, Antitumor,Agents, Cancer Chemotherapy,Agents, Chemotherapeutic Anticancer,Chemotherapy Agent, Cancer,Chemotherapy Agents, Cancer,Chemotherapy Drug, Cancer,Chemotherapy Drugs, Cancer,Drug, Antineoplastic,Drug, Antitumor,Drug, Cancer Chemotherapy,Drug, Chemotherapeutic Anticancer,Drugs, Antineoplastic,Drugs, Antitumor,Drugs, Cancer Chemotherapy
D016247 Information Storage and Retrieval Organized activities related to the storage, location, search, and retrieval of information. Information Retrieval,Data Files,Data Linkage,Data Retrieval,Data Storage,Data Storage and Retrieval,Information Extraction,Information Storage,Machine-Readable Data Files,Data File,Data File, Machine-Readable,Data Files, Machine-Readable,Extraction, Information,Files, Machine-Readable Data,Information Extractions,Machine Readable Data Files,Machine-Readable Data File,Retrieval, Data,Storage, Data
D016347 Medical Records Systems, Computerized Computer-based systems for input, storage, display, retrieval, and printing of information contained in a patient's medical record. Automated Medical Records Systems,Computerized Medical Records Systems,Automated Medical Record System,Automated Medical Record Systems,Automated Medical Records System,Computerized Medical Record System,Computerized Medical Record Systems,Computerized Medical Records System,Computerized Patient Medical Records,Medical Record System, Automated,Medical Record System, Computerized,Medical Record Systems, Automated,Medical Record Systems, Computerized,Medical Records System, Automated,Medical Records System, Computerized,Medical Records Systems, Automated
D053672 Electrochemotherapy A cancer treatment modality that uses pulsed electrical currents to permeabilize cell membranes (ELECTROPORATION) and thereby enhance the uptake of chemotherapeutic agents into the body's cells. Electrochemotherapies
D020407 Internet A loose confederation of computer communication networks around the world. The networks that make up the Internet are connected through several backbone networks. The Internet grew out of the US Government ARPAnet project and was designed to facilitate information exchange. World Wide Web,Cyber Space,Cyberspace,Web, World Wide,Wide Web, World

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