Functional equality of coordinating centers in a multicenter clinical trial. Experience of the International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT).
The International Mexiletine and Placebo Antiarrhythmic Coronary Trial (IMPACT) included clinical centers in both Europe and North America. The clinics were monitored by two Regional Coordinating Centers: one located in Baltimore, Maryland, for North American clinics; the other in Lyon, France, for European clinics. These coordinating Centers were in turn monitored by an independent Data Audit Center located in Chicago, Illinois. This article describes how computer systems and operational procedures were developed to allow the three IMPACT centers to exchange processed files for a common analysis by the two Regional Coordinating Centers. The problems encountered and the advantages of this organization are described and discussed.
D001145:Arrhythmias, Cardiac / Q000188:drug therapy*; D002624:Chemistry, Clinical / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D003625:Data Collection / Q000592:standards*; D004311:Double-Blind Method; D001330:Electronic Data Processing; D006801:Humans; D007391:International Cooperation; D008801:Mexiletine / Q000627:therapeutic use*; D010919:Placebos; D011437:Propylamines / Q000627:therapeutic use*; D011786:Quality Control; D011897:Random Allocation
D010919:Placebos; D011437:Propylamines; D008801:Mexiletine