Abstract
A multidose tolerance trial of an experimental antihypertensive drug was monitored by remote data entry. The study was conducted offshore with a 6-hour time difference between investigator and sponsor sites. All 12 patients were enrolled at the same time, making this 2-week study both short and data intensive. The primary end-points were blood pressure and various safety assessments. Personal computers (IBM-XT) were installed at both the investigator's site and the sponsor's site; data was transferred by phone lines via modems. Remote data entry provided a number of advantages over conventional monitoring. Because data was available for review within 48 hours of the patient visit, it was possible to identify miscalculations of certain parameters and protocol violations early in the course of the study. The capacity of the software to review data across parameters, visits, or patients allowed for better safety monitoring. In addition, graphs and tables of key endpoints were constructed within 24 hours of study completion, which saved considerable time in planning for future trials with this experimental drug.
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