Telecommunication technology for the management of large scale clinical trials: the Gissi experience.
The Coordinating Centre (CC) of the Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto miocardico (GISSI) used telecommunication technology to develop a computerized network system for the data management of the GISSI studies. Through a personal computer (PC), a communication program, a modem and a telephone line, the investigator in each participating centre can connect with a micro-computer at the CC, to recruit/randomize patients and download reports on the progress of the trial. In the first case, the investigator is required to answer a set of predefined questions, and thereby the system automatically checks eligibility criteria and randomly assigns the patient to a treatment arm. In the second case, once the investigator has made a choice from a list of standard reports and the relative query on CC central database, the generation, the formatting and the transfer of the selected report to the PC are executed automatically on line. The main advantages of this system are a reduction in number of mistakes in data completion and in the human and economic resources required, as well as the real time updating of participating centres. The system was successfully adopted in the GISSI-3 trial (200 Coronary Care Units and 19,394 patients enrolled), in the European arm of the CORE trial and it is currently being used in the GISSI-Prevenzione trial.
Santoro
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Department of Cardiovascular Research, Istituto di Ricerche Farmacologiche Mario Negri, Milano, Italy. eugenio@irfmn.mnegri.it
Nicolis
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Grazia Franzosi
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D000465:Algorithms; D002986:Clinical Trials as Topic / Q000379:methods*; D003195:Computer Communication Networks / Q000458:organization & administration*; D006801:Humans; D020407:Internet; D007558:Italy; D015337:Multicenter Studies as Topic / Q000379:methods*; D011897:Random Allocation; D012107:Research Design; D012984:Software; D013685:Telecommunications